YNHH opens neuroCOVID clinic to treat long-term neurological symptoms associated with COVID-19 – Yale Daily News

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Courtesy of Yale Medicine

For some COVID-19 patients, recovery does not mean the end of their suffering. Effects from the illness could linger in the brain and manifest through symptoms including persistent headaches, brain fog and cognitive difficulties.

To address these long-term neurological effects, doctors at the Yale New Haven Hospital have started a new neuroCOVID clinic one of the first of its kind in the United States. Led by a team of physicians at YNHH, the clinic started offering telehealth consults on Oct. 12 and will likely transition into a physical setting in the coming months.

In normal circumstances, starting a new clinic takes a while, but patients need help now so everybody was supportive in getting it off the ground, said Lindsay McAlpine, a neurology resident at YNHH and one of the clinics leaders.

Neuroinfectious disease specialist and assistant professor at the School of Medicine Shelli Farhadian said that the pulmonary division at YNHH swiftly established an outpatient clinic for post-COVID patients who were experiencing long-term respiratory difficulties. Some of these patients were never even hospitalized but still contended with lasting symptoms months after diagnosis. Pulmonologists running this service would often come across patients with neurological complaints, who they would refer to YNHH neurologists.

The volume of patients in need of special neurological attention was part of what inspired the creation of a specialized neuroCOVID clinic. Specific neurological symptoms could be addressed through the clinic while unloading some of the obligations from the hospitals primary neurology service. According to Farhadian, this dedicated service could really [help] us begin to understand just the basics of the spectrum of disease thats associated with COVID-19.

Because neurological manifestations have a wide range of variability, the clinic will harness the expertise of neuroinfectious disease doctors, clinical neurologists, neuropsychiatrists and other specialists to help patients.

According to behavioral neurologist Arman Fesharaki-Zadeh, this decision to coalesce forces should lead to a more conclusive understanding of elusive neurological symptoms.

I think we have a synergistic picture moving forward and hopefully a complementary set of expertise, Fesharaki-Zadeh said.

McAlpine said that, from her experience with inpatient consults, not only do patients often want to learn more about what is happening to them, but they also want to help others by participating in research.

Although the clinics primary mission is to help patients feel better, the doctors hope to work with those who wish to voluntarily enroll in studies to paint a clearer picture of how COVID-19 can affect the brain, Farhadian said.

We have an obligation, I think, and also an important opportunity here, to understand how and why these symptoms are happening, she said.

Fesharaki-Zadeh said that one of the first post-COVID patients he saw was a YNHH technician who had contracted the virus from a patient. Despite having no prior medical issues, he suffered a complicated infection course and was hospitalized for almost a month.

According to him, this patient not only struggled with respiratory difficulties, but also grappled with neurological and psychiatric manifestations, including anxiety, memory issues and difficulties organizing his thoughts. These observations, coupled with imaging that evidenced oxygen deprivation in his brain, struck Fesharaki-Zadeh.

I was really taken back by what I saw, he said. He didnt have any of the risk factors that I would associate with that type of presentation.

The brain is a three-pound organ that nevertheless expends 20 percent of the bodys oxygen supply, Fesharaki-Zadeh said. Because of that, the neurovascular effects of the coronavirus can be devastating. Fatal coronavirus-related strokes, for example, have been documented in the medical literature.

But, according to Fesharaki-Zadeh, not all phenomena affecting the brain have easily identifiable anatomical indications. Sometimes, patients experiencing psychiatric symptoms can have perfectly normal brain scans.

Fesharaki-Zadeh told the News that he hopes more nuanced ways of looking into brain function will be developed in the near future, possibly by measuring other biological footprints including molecules in synapses, the points of connection between neurons.

We have a few barriers to surpass, he said. But I think once those barriers are at least partially resolved it will be a new renaissance, a new era of clinical care.

Serena Spudich division chief of neurological infections and global neurology and one of the leaders of the new neuroCOVID clinic and her colleagues published a paper in The Lancet which details lessons learned from consults with neuroCOVID patients prior to opening the clinic.

Upon reviewing 100 post-COVID cases at YNHH spanning from Apr. 6 to May 29, they observed that, among patients requiring neurological consults, 25 percent were Hispanic and 25 percent were Black. In Connecticut as a whole, 17 percent of residents are Hispanic and 12 percent are Black.

The authors wrote that this discrepancy reflects the racial and ethnic disparities observed throughout the pandemic in the United States and in Europe, and that further action is required to understand and target the roots of this phenomenon.

These observations are important to highlight and guide future research on how we can, one, figure out why this disparity is happening, and two, create policies to address it, McAlpine said. Its definitely one piece of the puzzle, and its an important one that we want to figure out.

Farhadian also emphasized that doctors are currently open to what the spectrum of disease for COVID-19 could be.

She pointed out that it is possible that these long-term symptoms could be common to other extended conditions but have never been studied under the same level of scrutiny as now.

We dont know if the symptoms that people are reporting now are specific to COVID-19 or if these are symptoms that people may experience after any kind of critical illness really, and that were paying attention to them in a different way because of COVID-19, Farhadian said.

According to the New York Times, at the time of this writing, over 64,000 coronavirus cases have been reported in the state of Connecticut.

Maria Fernanda Pacheco | maria.pacheco@yale.edu

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YNHH opens neuroCOVID clinic to treat long-term neurological symptoms associated with COVID-19 - Yale Daily News

What We Know So Far about How COVID Affects the Nervous System – Scientific American

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Many of the symptoms experienced by people infected with SARS-CoV-2 involve the nervous system. Patients complain of headaches, muscle and joint pain, fatigue and brain fog, or loss of taste and smellall of which can last from weeks to months after infection. In severe cases, COVID-19 can also lead to encephalitis or stroke. The virus has undeniable neurological effects. But the way it actually affects nerve cells still remains a bit of a mystery. Can immune system activation alone produce symptoms? Or does the novel coronavirus directly attack the nervous system?

Some studiesincluding a recent preprint paper examining mouse and human brain tissueshow evidence that SARS-CoV-2 can get into nerve cells and the brain. The question remains as to whether it does so routinely or only in the most severe cases. Once the immune system kicks into overdrive, the effects can be far-ranging, even leading immune cells to invade the brain, where they can wreak havoc.

Some neurological symptoms are far less serious yet seem, if anything, more perplexing. One symptomor set of symptomsthat illustrates this puzzle and has gained increasing attention is an imprecise diagnosis called brain fog. Even after their main symptoms have abated, it is not uncommon for COVID-19 patients to experience memory loss, confusion and other mental fuzziness. What underlies these experiences is still unclear, although they may also stem from the body-wide inflammation that can go along with COVID-19. Many people, however, develop fatigue and brain fog that lasts for months even after a mild case that does not spur the immune system to rage out of control.

Another widespread symptom called anosmia, or loss of smell, might also originate from changes that happen without nerves themselves getting infected. Olfactory neurons, the cells that transmit odors to the brain, lack the primary docking site, or receptor, for SARS-CoV-2, and they do not seem to get infected. Researchers are still investigating how loss of smell might result from an interaction between the virus and another receptor on the olfactory neurons or from its contact with nonnerve cells that line the nose.

Experts say the virus need not make it inside neurons to cause some of the mysterious neurological symptoms now emerging from the disease. Many pain-related effects could arise from an attack on sensory neurons, the nerves that extend from the spinal cord throughout the body to gather information from the external environment or internal bodily processes. Researchers are now making headway in understanding how SARS-CoV-2 could hijack pain-sensing neurons, called nociceptors, to produce some of COVID-19s hallmark symptoms.

Neuroscientist Theodore Price, who studies pain at the University of Texas at Dallas, took note of the symptoms reported in the early literature and cited by patients of his wife, a nurse practitioner who sees people with COVID remotely. Those symptoms include sore throat, headaches, body-wide muscle pain and severe cough. (The cough is triggered in part by sensory nerve cells in the lungs.)

Curiously, some patients report a loss of a particular sensation called chemethesis, which leaves them unable to detect hot chilies or cool peppermintsperceptions conveyed by nociceptors, not taste cells. While many of these effects are typical of viral infections, the prevalence and persistence of these pain-related symptomsand their presence in even mild cases of COVID-19suggest that sensory neurons might be affected beyond normal inflammatory responses to infection. That means the effects may be directly tied to the virus itself. Its just striking, Price says. The affected patients all have headaches, and some of them seem to have pain problems that sound like neuropathies, chronic pain that arises from nerve damage. That observation led him to investigate whether the novel coronavirus could infect nociceptors.

The main criteria scientists use to determine whether SARS-CoV-2 can infect cells throughout the body is the presence of angiotensin-converting enzyme 2 (ACE2), a protein embedded in the surface of cells. ACE2 acts as a receptor that sends signals into the cell to regulate blood pressure and is also an entry point for SARS-CoV-2. So Price went looking for it in human neurons in a study now published in the journal PAIN.

Nociceptorsand other sensory neuronslive in discreet clusters, found just outside the spinal cord, called dorsal root ganglia (DRG). Price and his team procured nerve cells donated after death or cancer surgeries. The researchers performed RNA sequencing, a technique to determine which proteins a cell is about to produce, and they used antibodies to target ACE2 itself. They found that a subset of DRG neurons did contain ACE2, providing the virus a portal into the cells.

Sensory neurons send out long tendrils called axons, whose endings sense specific stimuli in the body and then transmit them to the brain in the form of electrochemical signals. The particular DRG neurons that contained ACE2 also had the genetic instructions, the mRNA, for a sensory protein called MRGPRD. That protein marks the cells as a subset of neurons whose endings are concentrated at the bodys surfacesthe skin and inner organs, including the lungswhere they would be poised to pick up the virus.

Price says nerve infection could contribute to acute, as well as lasting, symptoms of COVID. The most likely scenario would be that the autonomic and sensory nerves are affected by the virus, he says. We know that if sensory neurons get infected with a virus, it can have long-term consequences, even if the virus does not stay in cells.

But, Price adds, it does not need to be that the neurons get infected. In another recent study, he compared genetic sequencing data from lung cells of COVID patients and healthy controls and looked for interactions with healthy human DRG neurons. Price says his team found a lot of immune-system-signaling molecules called cytokines from the infected patients that could interact with receptors on neurons. Its basically a bunch of stuff we know is involved in neuropathic pain. That observation suggests that nerves could be undergoing lasting damage from the immune molecules without being directly infected by the virus.

Anne Louise Oaklander, a neurologist at Massachusetts General Hospital, who wrote a commentary accompanying Prices paper in PAIN, says that the study was exceptionally good, in part because it used human cells. But, she adds, we dont have evidence that direct entry of the virus into [nerve] cells is the major mechanism of cellular [nerve] damage, though the new findings do not discount that possibility. It is absolutely possible that inflammatory conditions outside nerve cells could alter their activity or even cause permanent damage, Oaklander says. Another prospect is that viral particles interacting with neurons could lead to an autoimmune attack on nerves.

ACE2 is widely thought to be the novel coronaviruss primary entry point. But Rajesh Khanna, a neuroscientist and pain researcher at the University of Arizona, observes that ACE2 is not the only game in town for SARS-CoV-2 to come into cells. Another protein, called neuropilin-1 (NRP1), could be an alternate doorway for viral entry, he adds. NRP1 plays an important role in angiogenesis (the formation of new blood vessels) and in growing neurons long axons.

That idea came from studies in cells and in mice. It was found that NRP1 interacts with the viruss infamous spike protein, which it uses to gain entry into cells. We proved that it binds neuropilin and that the receptor has infectious potential, says virologist Giuseppe Balistreri of the University of Helsinki, who co-authored the mouse study, which was published in Sciencealong with a separate study in cells. It appears more likely that NRP1 acts as a co-factor with ACE2 than that the protein alone affords the virus entry to cells. What we know is that when we have the two receptors, we get more infection. Together, its much more powerful, Balistreri adds.

Those findings piqued the interest of Khanna, who was studying vascular endothelial growth factor (VEGF), a molecule with a long-recognized role in pain signaling that also binds to NRP1. He wondered whether the virus would affect pain signaling through NRP1, so he tested it in rats in a study that was also published in PAIN. We put VEGF in the animal [in the paw], and lo and behold, we saw robust pain over the course of 24 hours, Khanna says. Then came the really cool experiment: We put in VEGF and spike at the same time, and guess what? The pain is gone.

The study showed what happens to the neurons signaling when the virus tickles the NRP1 receptor, Balistreri says. The results are strong, demonstrating that neurons activity was altered by the touch of the spike of the virus through NRP1.

In an experiment in rats with a nerve injury to model chronic pain, administering the spike protein alone attenuated the animals pain behaviors. That finding hints that a spike-like drug that binds NRP1 might have potential as a new pain reliever. Such molecules are already in development for use in cancer.

In a more provocative and untested hypothesis, Khanna speculates that the spike protein might act at NRP1 to silence nociceptors in people, perhaps masking pain-related symptoms very early in an infection. The idea is that the protein could provide an anesthetic effect as SARS-CoV-2 begins to infect a person, which might allow the virus to spread more easily. I cannot exclude it, says Balistreri. Its not impossible. Viruses have an arsenal of tools to go unseen. This is the best thing they know: to silence our defenses.

It still remains to be determined whether a SARS-CoV-2 infection could produce analgesia in people. They used a high dose of a piece of the virus in a lab system and a rat, not a human, Balistreri says. The magnitude of the effects theyre seeing [may be due to] the large amount of viral protein they used. The question will be to see if the virus itself can [blunt pain] in people.

The experience of one patientRave Pretorius, a 49-year-old South African mansuggests that continuing this line of research is probably worthwhile. A motor accident in 2011 left Pretorius with several fractured vertebrae in his neck and extensive nerve damage. He says he lives with constant burning pain in his legs that wakes him up nightly at 3 or 4 A.M. It feels like somebody is continuously pouring hot water over my legs, Pretorius says. But that changed dramatically when he contracted COVID-19 in July at his job at a manufacturing company. I found it very strange: When I was sick with COVID, the pain was bearable. At some points, it felt like the pain was gone. I just couldnt believe it, he says. Pretorius was able to sleep through the night for the first time since his accident. I lived a better life when I was sick because the pain was gone, despite having fatigue and debilitating headaches, he says. Now that Pretorius has recovered from COVID, his neuropathic pain has returned.

For better or worse, COVID-19 seems to have effects on the nervous system. Whether they include infection of nerves is still unknown like so much about SARS-CoV-2. The bottom line is that while the virus apparently can, in principle, infect some neurons, it doesnt need to. It can cause plenty of havoc from the outside these cells.

Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.

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What We Know So Far about How COVID Affects the Nervous System - Scientific American

Marcus Neuroscience Institute names Khalid A. Hanafy, M.D., Ph.D., Medical Director of Neurocritical Care and Research – Baptist Health South Florida

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October 13th, 2020 Baptist Health South Florida

Boca Raton, FL October 13, 2020 Khalid A. Hanafy, M.D., Ph.D., has joined Marcus Neuroscience Institute at Boca Raton Regional Hospital, part of Baptist Health, as medical director of neurocritical care and director of research. He specializes in the care of subarachnoid hemorrhage patients and the study of neuroinflammation. He also serves as associate professor of neurology at Florida Atlantic University Charles E. Schmidt College of Medicine in Boca Raton. He is board certified in neurology and neurocritical care.

Dr. Hanafy joined Marcus Neuroscience Institute from Beth Israel Deaconess Medical Center/Harvard Medical School in Boston, Mass., where he served as the director of the neurological intensive care unit and was an assistant professor of neurology at Harvard Medical School.

We are pleased to welcome Dr. Hanafy to Marcus Neuroscience Institute, said Frank D. Vrionis, M.D., MPH, Ph.D., Institute director and chief of neurosurgery. His clinical skills, research acumen and leadership in the field of neurology will greatly benefit our team and our patients.

As the Institutes director of research, Dr. Hanafy is principal investigator of cutting-edge studies that seek to bring the most advanced, personalized treatments to subarachnoid hemorrhage patients and improve their survival rates and health outcomes. His groundbreaking work in neuroinflammation has been funded by the National Institutes of Health, American Heart Association, American Academy of Neurology, and Massachusetts Institute of Technology. Marcus Neuroscience Institute is at the forefront of stem cell therapeutics, and Dr. Hanafy and Dr. Vrionis have already initiated clinical trials using stem cells in critically ill COVID patients. Together, they will expand research and clinical trials using stem cells for the treatment of other neurological conditions, such as stroke and brain tumors.

Dr. Hanafy has authored more than 40 articles, book chapters and invited editorials in peer-reviewed scientific publications and serves on the editorial boards of scholarly journals in his field. He is a member of several professional societies, including the American Academy of Neurology, Society for Neuroscience Research, Society of Critical Care Medicine, and Neurocritical Care Society.

Dr. Hanafy earned his medical degree and doctorate degree in molecular biology at the University of Texas Medical Scientist Training Program at Houston, a dual degree program of the University of Texas McGovern Medical School and MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences. He did his thesis graduate work under Dr. Ferid Murad, the 1998 Nobel laureate. He returned to these Houston facilities to complete a neurology residency following an internal medicine internship at the University of Texas Southwestern at Parkland Memorial Hospital in Dallas. He concluded his medical training with a two-year fellowship in neurological critical care at Columbia University Medical Center in New York City.

About the Marcus Neuroscience InstituteThe Marcus Neuroscience Institute at Boca Raton Regional Hospital is an innovative nexus for neurologic and neurosurgical care. The 57,000-square-foot facility houses a 20-bed Neuro Intensive Care and Step-Down Unit, four dedicated operating rooms including one equipped with intraoperative MRI and two with intraoperative CT capability and a biplane angiography suite, a crucial component in the diagnosis and care of neurological conditions. The Institute has a staff of five neurosurgeons and nine neurologists who represent some of the most respected clinicians in their fields and is affiliated with Florida Atlantic Universitys Charles E. Schmidt College of Medicine.

About Boca Raton Regional HospitalBoca Raton Regional Hospital is part of Baptist Health South Florida, the largest healthcare organization in the region, with 11 hospitals, nearly 23,000 employees, more than 4,000 physicians and more than 100 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences. In addition, it includes Baptist Health Medical Group; Baptist Health Quality Network; and Baptist Health Care On Demand, a virtual health platform. A not-for-profit organization supported by philanthropy and committed to our faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the Worlds Most Ethical Companies. For more information, visit BaptistHealth.net/Newsroom and connect with us on Facebook, Instagram, Twitter and LinkedIn.

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Marcus Neuroscience Institute names Khalid A. Hanafy, M.D., Ph.D., Medical Director of Neurocritical Care and Research - Baptist Health South Florida

Neurelis Announces Four Poster Presentations For The Joint Meeting Of The International Child Neurology Association And Child Neurology Society -…

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SAN DIEGO, Oct. 16, 2020 /PRNewswire/ -- Neurelis, Inc., announced today the company has four posters being presented at the 16th annual International Child Neurology Association Congress/49th annual Child Neurology Society Meeting. Due to the COVID-19 pandemic, posters are available online during the organizations' virtual meetings.

Neurelis Chief Medical Officer Enrique Carrazana, M.D., said the poster presentations continue to validate the safety, pharmacokinetics, and tolerability of VALTOCO (diazepam nasal spray) in children with epilepsy aged 6 and older. VALTOCO was approved by the U.S. Food and Drug Administration (FDA) on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older. In its approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as part of the Orphan Drug Exclusivity designation.

"The data continue to demonstrate that VALTOCO is an important treatment option for children with epilepsy suffering from seizure clusters,"Dr. Carrazana said.

Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, said, "It's important to note that similar to what we have seen in adults, a single dose of VALTOCO was used in 88 percent of seizure episodes in children studied. This gives physicians and parents confidence that VALTOCO has a sustained response."

The details for the poster presentations are as follows and are available online here; type VALTOCO in search bar to view.

Abstract: Time to Second Doses in Children With Epilepsy Treated With Valtoco (Diazepam Nasal Spray): Interim Subgroup Results From a Phase 3, Open-Label, Repeat Dose Safety Study

Abstract: Safety of Valtoco (NRL-1; Diazepam Nasal Spray) in Children With Epilepsy: Updated Interim Subgroup Results From a Phase 3, Open-Label, Repeat Dose Safety Study

Abstract: Importance of Seizure Time of Day in Children With Epilepsy Treated With Valtoco (Diazepam Nasal Spray): Interim Subgroup Results From a Phase 3, Open-Label, Repeat Dose Safety Study

Abstract: Valtoco (Diazepam Nasal Spray) in Children With Epilepsy Aged 6-11 Years: Interim Subgroup Results By Frequency of Usage From a Phase 3, Open-Label, Repeat Dose Safety Study

About VALTOCO

VALTOCO is a proprietary formulation of diazepam incorporating the science of Intravail. Intravail transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. In its approval of VALTOCO, the FDA also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO's intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). In a long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO was evaluated and more than 4,000 seizures were treated. The clinical trial included adult and pediatric patients aged 6 and older. VALTOCO was generally safe and well tolerated during clinical studies. The most common adverse reactions for diazepam (at least 4%) were somnolence, headache, and nasal discomfort.For more information on VALTOCO, please visit http://www.valtoco.com.

About Neurelis

Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. On January 10, 2020, the U.S. Food and Drug Administration (FDA) approved Neurelis' VALTOCO(diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. In addition to VALTOCO, the company is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of psychomotor agitation (PMA) symptoms outside of the medical setting. The Neurelis technology platform includes Intravail, ProTek and Hydrogel, three proprietary, noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules, and small molecules. For more information on Neurelis, please visit http://www.neurelis.com.

Important Safety Information about VALTOCO:

Indication

VALTOCO (diazepam nasal spray)is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.

IMPORTANT SAFETY INFORMATION

RISK FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Contraindications: VALTOCO is contraindicated in patients with:

Central Nervous System (CNS) Depression

Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits.

The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.

Glaucoma

Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol-preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Adverse Reactions

The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.

To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read full Prescribing Information, including Boxed Warning, for additional important safety information.

For More Information:Mark Leonard[emailprotected]858-251-2100

SOURCE Neurelis, Inc.

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In brief: New neurology chief at St. Clair, covid-19 relief and more in the South Hills – TribLIVE

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St. Clair Hospital welcomes new chief of neurology

St. Clair Hospital has appointed noted neurologist Maxim D. Hammer, M.D., MBA, as its new chief of neurology.

Hammer joins St. Clair from UPMC, where he held numerous titles, including vice chairman, clinical affairs, Department of Neurology; clinical director of neurology; and director of stroke Services at UPMC Mercy Hospital, where he helped develop the Stroke Clinic. Hammer founded and directed the Neurosonology lab, which provides outpatient and inpatient services, using carotid duplex and transcranial ultrasonography.

He earned his medical degree at Albany Medical College, Albany, N.Y., and completed his neurology residency at Cleveland Clinic, where he was elected chief resident. He also completed a Vascular Neurology Fellowship at UPMC. Hammer holds an executive healthcare masters degree in business administration from the University of Pittsburgh Katz School of Business. He is an associate professor, Department of Neurology, at University of Pittsburgh School of Medicine. Hammer is board-certified in neurology, as well as in vascular neurology.

Covid-19 relief funding

Fire and EMS companies in the South Hills will share more than $200,000 in state grants awarded to offset operational expenses related to covid-19.

State Rep. Harry Readshaw (D-Allegheny) said the grants awarded by the Office of State Fire Commissioner are necessary to help first responders continue operating as they face additional expenses and a loss of fundraising.

The awards are as follows:

Baldwin Emergency Medical Services Inc.: $23,973

Baldwin Independent Fire Co. No 1: $24,520

Baldwin Emergency Medical Services Inc.: $24,238

Brentwood Volunteer Fire Company: $20,752

Brentwood Emergency Medical Services: $15,048

Mount Oliver Hook and Ladder Company: $23,288

Pleasant Hills Volunteer Fire Co.: $25,068

South Baldwin Volunteer Fire Co.: $22,094

Whitehall Fire Co.: $25,342

Readshaw said the funding may be used for operational expenses such as apparatus repair, fuel, personal protective equipment, utilities, insurance and lost revenue related to pandemic restrictions. It may also be used for cleaning, sanitizing and disinfecting equipment and property or other expenses needed to prevent the spread of disease.

The funds must be used for expenses initiated on or after March 6 and completed on or before Dec. 30 to be eligible for the grant program.

Virtual Turkey Trot 5K

Bethel Park Recreations 2020 Thanksgiving Turkey Trot 5K Run & Walk is offering individuals of all ages the chance to participate in the fun annual event being held virtually this year.

Those registered can run their race between Nov. 8-30.

Registration cost is $40 for adults and $20 for children 12 and under.

Each participant will receive a bib number, finisher certificate, finisher medal and T-shirt. Shirts and medals will be shipped the week of Nov. 30.

To register, stop by the Bethel Park Community Center, 5151 Park Ave., Bethel Park, 15102, or visit runsignup.com/Race/PA/BethelPark/ThanksgivingDayBethelParkRecreationTurkeyTrot5KRunWalk.

For questions or more information, call Bethel Park Recreation at 412-831-1328.

Womens Business Network

Part networking group, part mastermind group, Womens Business Network provides members with the tools to be successful while expanding her circle of influence and marketplace.

All professional women are welcome to attend a meeting as a guest at no charge. Many meetings are being held virtually, so check with a local chapter representative for more information.

The Mt. Lebanon Chapter meets on the second and fourth Tuesdays of the month at 8:30 a.m. The next meeting is Oct. 27. To find out more, contact chapter representative Marlene Will-Knapp at 412-833-9279.

The South Hills Chapter meets on the first and third Thursdays of the month at 8 a.m. To find out more, contact chapter representative Katie Martin at 724-288-1819.

The All Virtual Chapter meets on the first and third Wednesdays of the month at 7:30 p.m. Guests are welcome to attend at no cost. For more information, contact Jennifer at 412-908-1663.

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Neurology Department calls for grant proposals to support Alzheimer’s disease and related research – The South End

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The Department of Neurology at the Wayne State University School of Medicine, partnered with Department of Psychiatry and Behavioral Sciences, has an endowment from the Albert and Goldye J. Nelson Fund to support scientific research in the detection, pathogenesis, molecular genetics, neurobiology and therapeutic development to cure Alzheimers disease and related disorders. Available funds for the coming fiscal year are between $50,000 and $100,000.

The Neurology Department is accepting proposals for FY 2021.Interested applicants must submit a proposal that consists of:

1. Specific aim (one page)

2. Research plan (six pages)

3. Human subjects if applicable (two pages)

4. Vertebral animals if applicable (two pages)

5. Biosketch (National Institutes of Health format) for all personnel involved in the study

6. Budget with budget justification

7. Resource

8. Support letters

Funds may not be used to cover the principal investigators salary. Proposals are for two to three years. Applicants must have at least a .25 FTE faculty appointment at the School of Medicine.

The deadline for submission is Jan. 31, 2021. The grant will begin Aug. 1, 2021.

Submit proposals to Carla Santiago, research administrator, WSU Department of Neurology - 8D UHC, 4201 St. Antoine, Detroit, MI 48201. E-mail:csantiago@med.wayne.edu.

Please note that the grant submissions must follow grant guidelines. Please click here for the guidelines.

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Neurology Department calls for grant proposals to support Alzheimer's disease and related research - The South End

El Husseini, Spector discuss transforming telestroke and racial disparities with AAN – Duke Department of Neurology

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The Duke Neurology Departments Nada El Husseini, MD, and Andrew Spector, MD, both appeared in the American Academy of Neurologys (AAN) AAN Alumni Leadership Newsletter for October 2020, where they discussed transforming telestroke during a global health crisis and how neurologists can reduce racial health disparities.

El Husseini, a 2020 graduate of the AANs Transforming Leadership Program (TLP), spoke with Daniel Jose Correa, MD, MSC, about her year-long project to optimize telestroke care. El Husseini discussed her efforts to add standardized, patient-centered measures of outcomes in Dukes stroke network, improve wellness and satisfaction of telestroke providers, and include telestroke education in our Vascular Neurology Fellowship. Correa and El Husseini also discussed North Carolina and Dukes response to the COVID-19 pandemic, and how that pandemic affected (and continues to affect) telemedicine and the needs of patients with neurological conditions.

Spector, meanwhile, spoke with Ima Ebong, MD, as representatives of neurologists with different racial backgrounds to provide their perspectives on racial inequalities, and how the AAN and individual neurologists can make a difference.

Read both of these articles here in the AANs Leadership Alumni Newsletter.

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El Husseini, Spector discuss transforming telestroke and racial disparities with AAN - Duke Department of Neurology

Woman has four-year wait to see Northern Ireland neurologist – The Guardian

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A single mother of six children has been waiting four years and four months to see a consultant for suspected multiple sclerosis in Northern Ireland as officials admit in leaked court papers that health waiting lists have spiralled out of control.

Although referred to a neurologist in June 2017, Eileen Wilson, 47, has still not received a date to see the specialist despite suffering choking episodes that leave her blue in the face, loss of muscle control and a multitude of other symptoms.

She is one of the hundreds of thousands of patients suffering in silence because of the chronic waiting lists that have been building since 2013, according to testimony submitted to the high court.

Her case is at the centre of two landmark cases to be heard in December and January against the Northern Ireland health minister, Robin Swann, the UK chancellor, Rishi Sunak, and the health secretary, Savid Javid, who were named as defendants in the case last week after affidavits from Northern Irelands Department of Health blamed years of underfunding for the crisis.

Sitting in her garden in her army veteran house in Belfast, Wilson said she would not give up the fight even though the human rights commission, her GP, and her MP, Gavin Robinson, have all failed to get her an appointment.

I just want to know whats wrong with me, she says.

She explains how she staggers around her home like a drunk even though she does not drink and now suffers episodes of sleep paralysis, which has been likened to locked-in syndrome.

When I go to bed all the worry is there, its like a washing machine on full spin, she said.

I worry that if I fall or choke, thats going to be the end of it. Die? Yes, she answers. It can happen anytime. Its like something is stuck in my throat. Ive gone blue in the face. It lasts for a few minutes but it feels like hours, she said.

To her shock, she heard through her MP that her GPs referral had been downgraded from urgent to routine, with the chief executive of South Eastern health and social care trust telling Robinson that regrettably the waiting time for an appointment was 163 weeks three years and 13 weeks.

I am very sorry that we have not yet been able to offer Mrs Wilson an appointment, he said.

Four years and four months later, she is none the wiser.

Her solicitor, Ciaran OHare of McIvor Farrell, has already applied successfully for leave for a judicial review, which is now listed for January with a second case expedited for hearing in December over a failed bid to get her an appointment overseas under EU legislation transposed into domestic law.

He said her case was for the benefit of the people of Northern Ireland and is asking the court to conclude that the waiting lists, the worst in the UK for much of the past decade, are unlawful and a breach of human rights.

This saga has been going on in Northern Ireland for over 10 years and hospital waiting lists have been getting longer and longer. We do not have the NHS here, like in England; we have health and social care and it doesnt work, said OHare.

This is the first case of its kind and it is absolutely crucial because something must be done to end the suffering that is occurring every single day with people languishing and dying on hospital waiting lists, he added.

Recent figures show nearly a fifth of Northern Irelands population are waiting for a first appointment and more than half of those are waiting for more than a year.

It is the case that the majority of people on the waiting list are waiting for more than a year, which is pretty extraordinary, said Mark Dayan, a policy analyst at the health services thinktank the Nuffield Trust.

Waiting lists are the worst in the UK and possibly in Europe. Last week, the childrens commissioner revealed that 24 children with confirmed or suspected cancer were among the 17,000 minors waiting more than a year to see a specialist.

Affidavits submitted to the courts and seen by the Guardian paint a grim picture.

A senior official in the Department of Health in his testimony, said the delays were extremely regrettable but the health minister had repeatedly said a significant increase in funding was necessary to make a return to acceptable levels.

While doctors, nurses, other health professionals and managers have made every effort to ensure that any negative impact on patients has been kept to a minimum, waiting times have continued to grow to a level where many believe that they are now out of control, he added.

Dayan said Northern Irelands waiting lists began to spiral to more and more unacceptably poor levels relative to the rest of the UK 10 years ago.

He said one year-plus waits were almost unheard of in England before Covid, but have been common in Northern Ireland. Out of an estimated 460,000 on a waiting list, 250,000 have been on it for more than a year, he said.

The Department of Health declined to comment due to ongoing court proceedings.

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Woman has four-year wait to see Northern Ireland neurologist - The Guardian

The Practice of Neurology in Mongolia – WFN News

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Training has been cut from 2 years to 1 year; residents are unsalaried; exams are not standardized.

I am glad to have the great opportunity to write about the practice of neurology in my country, Mongolia. Let's begin with its interesting history. The practice of neurology got its start in Mongolia in 1939 with the establishment of 10 neurologic beds in the Central Hospital by the Russian neurologist Dr. N.Ya. Semyonova.

In 1947, a neurologist who was a faculty member of Leningrad Medical High School, Dr. G.Ya. Liberson, founded the neurology department in the medical faculty of Mongolian State University. Dr. G. Ya. Liberson's work was taken over by the first Mongolian neurologists, Dr. G. Lodon and Dr. L. Dagzmaa.

In the 1950s and 1960s, the first scientific research works were done in the field of neuroinfections (neurolues, epidemic encephalitis, polymyelitis) according to the social and ecological requirements of the country at that time (G. Lodon, D. Rawdandorj). At this time, the second adult neurology ward and the first one for children were launched, the first department of neurosurgery was founded, and the use of new diagnostic methods such as EEG and pneumoencephalography (PEG) was adopted (Tsagaankhuu G et al. 2007).

In the 1970s and 1980s, the neurologic service in the country expanded to become an independent medical branch and improved the quality of neurologic care by increasing the number of neurologists (about 100) and founding neurologic wards in all province hospitals (each with about 20 beds and two neurologists). At that time, the Mongolian neurologists were supported mostly from Ukrainian neurologists (E.P. Zagorowsky), and inherited their methods (Tsagaankhuu G et al. 2007).

The political changes in the late 1980s and early 1990s with the end of the Cold War smashed completely the old socialist social system in the country. While the loss of contact with Russian neurologists was keenly felt, one benefit was that Mongolian neurology was offered new chances to develop professional relationships with neurologists from other countries. In 2002, the Mongolian neurologic association "Monneurology" was founded, and it became a member of the WFN. Also in 2002 the first international epilepsy seminarworkshop was held with the support of the ASEAN Epilepsy Society.

In 2006, the first international neurologic INFOSeminar was held in Ulaanbaatar, with the initiation of WFN and international participation opening new opportunities in foreign relations. Today, the neurologic service in Mongolia consists of more than 20 medical doctors with PhDs and about 200 neurologists. The number of neurologists in Mongolia is 7.8 per 100,000 people, which is a very high proportion compared to most other countries of the world. About 60% of all Mongolian neurologists are working in the capital Ulaanbaatar, where more than a half of the population is concentrated (1.5 million of Mongolia's entire population of 2.5 million people live in the capital city). The number of neurologic beds is about 900 in the whole country, about 3.7 per 10,000 (Baasanjaw D et al, 2006).

In recent years, neurologic research has focused on the epidemiology of most common neurologic disorders such as stroke, epilepsy, neurodegenerative and neuroinflammatory diseases. The stroke epidemiology study revealed that there is a high percentage of the hemorrhagic type (about 50% vs. about 40% ischemic stroke and 10% subarachnoid hemorrhage), which requires special attention to prevention (Baasanjaw D et al, 1999). Also, several research studies were done on epilepsy, which is a significant cause of disability in Mongolia. But because of flaws in the design of these studies, their findings do not distinguish various exact types of epilepsy, limiting the studies' usefulness.

From 1997 to 2000, the neurogenetic group from the U.S. National Institutes of Health, which was led by Dr. Lev Goldfarb, collaborated with the Mongolian Medical Research Institute to undertake research on neurohereditary diseases in Mongolia. The investigators found a high prevalence of certain neurogenetic disorders associated with certain regions of the country. For example, Charcot Marie Tooth [CMT] type 2 disease was prevalent in Arkhangai province, where there were about 100 cases in the population of 97,000. Other disorders with a geographic prevalence included the observations of CMT type 1 disease in Khulunbuir, Dornod province; hereditary spastic spinal paralysis in the Khowd and Uws provinces; and familial oligophrenia in Dornod province. Cases of myotonic dystrophy were registered in nearly all provinces.Not all provinces were involved in the epidemiologic research, but the fact that hereditary neurologic disorders occur in high prevalence within a country that has small population deserves special clinical attention.

Despite the high number of specialists and neurology beds in Mongolia, there are many problems resulting from the difficult current socioeconomic situation in the country. There is insufficient medical and social insurance, both of which were newly founded in Mongolia only 10 years ago.

The low level of knowledge and outdated training methods of some neurologists are leading to misdiagnosis and treatment failures in many cases. Neurologic residency training lasted for 2 years during the period from 1997 to 2001 and included psychiatry training. Since 2002, the training program has been shortened to 1 year. The quality of clinical training is limited by numerous problems: Neurology residents must often pay for part or all of their training costs; they lack proper workplaces; and they are unsalaried. In most respects, neurology residency training in Mongolia lacks standards, adequate supervision, and standardized examinations.

Established neurologists require but usually do not receive training in order to bring them up to date with the massive increase in new diagnostic methods in recent years. Without such training they risk misinterpreting test results. Pharmaceutical companies are not inclined to introduce their new drugs in Mongolia because our small population means fewer sales for them. Some important medical branches in neurology, such as neurorehabilitation, are still nonexistent in the country. Instead, this type of treatment has been replaced by minimally effective traditional treatment methods.

To become familiar with the latest versions of diagnostic and treatment research, the neurologic consultant of the Ministry of Health began to implement a CME program for neurologists. The younger generation of neurologists eagerly participates in these CME opportunities. All recent information must be translated into Mongolian because knowledge of the English language is not widespread. We are also working on setting and renewing the special standards and guidelines for neurologic diseases which can be generally diagnosed and treated. Mongolia is located in the center of the Asian continent, is bordered by Russia and China, and, belongs neither among the Southeast, Pacific, nor Middle East countries.

The climate is dry and cold. Mongolia has its own culture and language, and a population with a nomadic style of life that has existed for thousands of years. We hope our geographical, cultural, and climatic conditions will not be a barrier for expanding our foreign relationships, and we continue to makes strides to improve our neurologic services in Mongolia.

At time of print, SARANGEREL JAMBAL, M.D., known to her friends as Saraa, is a neurologist at the "Reflex" Neurological Clinic in Ulaanbaatar, Mongolia.

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The Practice of Neurology in Mongolia - WFN News

Insufficient and Excessive Sleep Associated With Faster Cognitive Decline – Neurology Advisor

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Sleeping too little or too much, meaning no more than 4 hours per night or at least 10 hours per night, respectively, is associated with faster cognitive decline compared with sleeping approximately 7 hours per night, according to study results published in JAMA Network Open.

Study researchers from China sought to examine the relationship between sleep duration and cognitive decline. They achieved this by conducting an observational study, analyzing a pooled cohort of participants from waves 4 to 8 (2008-2009 to 2016-2017) of the English Longitudinal Study of Ageing and waves 1 to 3 (2011 to 2015) of the China Health and Retirement Longitudinal Study. In total, the pooled cohort included 9254 individuals from England who were at least 50 years of age (55.9% women; mean age, 64.6 years; median follow-up duration, 8 years) and 10,811 individuals living in China who were at least 45 years of age (50.2% men; mean age, 57.8 years; median follow-up duration, 4 years).

The investigators assessed face-to-face interview responses to obtain self-reported, per-night sleep duration information from participants. Sleep duration data were then correlated with global cognitive z scores, which were calculated based on the immediate and delayed recall test, animal fluency test, serial sevens test, an intersecting pentagon copying test, as well as a date orientation test.

Compared with a reference group of participants who slept for approximately 7 hours per night, global cognitive z scores declined significantly faster for those who slept no more than 4 hours per night (pooled =-0.022; 95% CI, -0.035 to -0.009; P =.001) or at least 10 hours per night (pooled =-0.033; 95% CI, -0.054 to -0.011; P =.003) in an analysis adjusted for age, body mass index, and other covariates. The investigators observed an inverted U-shaped association between sleep duration and global cognitive decline, in addition to memory in these participants.

Limitations of this study included its observational design, the reliance on self-reported data for the assessment of sleep duration, and the use of isolated tasks rather than more sensitive methods for the measurement of cognitive function.

The study researchers concluded that the inverted U-shaped association indicates that cognitive function should be monitored in middle-aged and older individuals with insufficient or excessive sleep duration.

Reference

Ma Y, Liang L, Zheng F, Shi L, Zhong B, Xie W. Association between sleep duration and cognitive decline. JAMA Netw Open. Published online September 21, 2020. doi:10.1001/jamanetworkopen.2020.13573

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Insufficient and Excessive Sleep Associated With Faster Cognitive Decline - Neurology Advisor

Recurrent GBM brain tumors with few mutations respond best to immunotherapy – Duke Department of Neurology

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Glioblastoma brain tumors are especially perplexing. Inevitably lethal, the tumors occasionally respond to new immunotherapies after theyve grown back, enabling up to 20% of patients to live well beyond predicted survival times.

What causes this effect has long been the pursuit of researchers hoping to harness immunotherapies to extend more lives.

New insights from a team led by Dukes Preston Robert Tisch Brain Tumor Center, including Katherine Peters, MD, PhD, Dina Randazzo, DO, and Annick Desjardins, MD provide potential answers. The team found that recurring glioblastoma tumors with very few mutations are far more vulnerable to immunotherapies than similar tumors with an abundance of mutations.

The finding, appearing online Jan. 13 in the journal Nature Communications, could serve as a predictive biomarker to help clinicians target immunotherapies to those tumors most likely to respond. It could also potentially lead to new approaches that create the conditions necessary for immunotherapies to be more effective.

Its been frustrating that glioblastoma is incurable and weve had limited progress improving survival despite many promising approaches, said senior author David Ashley, MD, PhD, professor in the departments of Neurosurgery, Medicine, Pediatrics and Pathology at Duke University School of Medicine.

Weve had some success with several different immunotherapies, including the poliovirus therapy developed at Duke, Ashley said. And while its encouraging that a subset of patients who do well when the therapies are used to treat recurrent tumors, about 80% of patients still die.

Ashley and colleagues performed genomic analyses of recurrent glioblastoma tumors from patients treated at Duke with the poliovirus therapy as well as others who received so-called checkpoint inhibitors, a form of therapy that releases the immune system to attack tumors.

In both treatment groups, patients with recurrent glioblastomas whose tumors had few mutations survived longer than the patients with highly mutated tumors. This was only true, however, for patients with recurrent tumors, not for patients with newly diagnosed disease who had not yet received treatment.

This suggests that chemotherapy, which is the standard of care for newly diagnosed glioblastoma, might be altering the inflammatory response in these tumors, Ashley said, adding that chemotherapy could be serving an important role as a primer to trigger an evolution of the inflammation process in recurrent tumors.

Ashley said the finding in glioblastoma could also be relevant to other types of tumors, including kidney and pancreatic cancers, which have similarly shown a correlation between low tumor mutations and improved response to immunotherapies.

In addition to Ashley, study authors include Matthias Gromeier, Michael C. Brown, Gao Zhang, Xiang Lin, Yeqing Chen, Zhi Wei, Nike Beaubier, Hai Yan, Yiping He, Annick Desjardins, James E. Herndon II, Frederick S. Varn, Roel G. Verhaak, Junfei Zhao, Dani P. Bolognesi, Allan H. Friedman, Henry S. Friedman, Frances McSherry, Andrea M. Muscat, Eric S. Lipp, Smita K. Nair, Mustafa Khasraw, Katherine B. Peters, Dina Randazzo, John H. Sampson, Roger E. McLendon and Darell D. Bigner.

The study received support from The Brain Tumor Research Charity, Jewish Communal Fund, Circle of Service Foundation, Uncle Kory Foundation, Department of Defense (W81XWH-16-1-0354) and the National Institutes of Health (R35CA197264, P01CA154291, P50CA190991, R01NS108773, R01NS099463, R21NS112899, P01CA225622, F32CA224593). Support was also received through the Angels Among Us fundraising event and a gift from the Asness Family.

Authors Gromeier, Brown, Desjardins, Bolognesi, Henry Friedman, Nair, Sampson, Bigner and Ashley own intellectual property related to the poliovirus therapy, which has been licensed to Istari Oncology, Inc. Gromeier, Desjardins, Bolognesi, Allan Friedman, Henry Friedman and Bigner hold equity in Istari Oncology, Inc. Additional disclosures are provided in the published study.

This story originally appeared on the Duke Health website. View it in its original location here.

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Recurrent GBM brain tumors with few mutations respond best to immunotherapy - Duke Department of Neurology

COVID-19s Effects on the Brain – The Scientist

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When epidemics and pandemics washed over humanity through the ages, watchful doctors noticed that in addition to the usual, mostly respiratory ailments, the illnesses also seemed to trigger neurological symptoms. One British throat specialist observed in the late 1800s that influenza appeared to run up and down the nervous keyboard stirring up disorder and pain in different parts of the body with what almost seems malicious caprice. Indeed, some patients during the 188992 influenza pandemic reportedly became afflicted with psychoses, paranoia, stabbing pains, and nerve damage. Similarly, scholars have linked the 1918 flu pandemic to parkinsonism, neuropsychiatric disorders, and a broadly coinciding outbreak of the sleeping sickness encephalitis lethargica, which would often arrest patients in a coma-like statealthough researchers still debate whether the two are causally connected.

That SARS-CoV-2, the culprit of the COVID-19 pandemic, is also associated with neurological symptoms isnt entirely surprising, given some evidence that its close relatives, MERS-CoV and SARS-CoV-1, have been associated with neurological symptoms too. But the proportion of patients developing such symptomsand their mounting collective numbershas startled some scientists. When the news broke early last year that some 36 percent of COVID-19 patients in Wuhan hospitals were developing impaired consciousness, seizures, sensory impairments, and other neurological symptoms, that floored me, remarks Shibani Mukerji, a neuroinfectious disease specialist at Massachusetts General Hospital.

Autopsy studies have revealed a range of recurrent neuropathological features in hospitalized COVID-19 patients.

Now, entire clinics are being created specializing in subsets of patients with neurological symptoms, including one in London co-led by Patricia McNamara, a neurologist at the National Hospital for Neurology and Neurosurgery. She broadly separates neurological symptoms into two diverse groups. The firstdescribed in several reports last yearcomprises acute symptoms often afflicting hospitalized patients with severe disease. These can manifest as a confused, delirious state known as encephalopathy, or as strokes, peripheral nerve damage, or encephalitis, an inflammation of the brain. The second group represents long-term symptoms usually following milder infections, ranging from headaches, fatigue, sensations of numbness or tingling, and cognitive difficulties to occasionally seizures and inflammation of the heart, McNamara says. The people Ive seen so far [in this group] are people who slowly improve, but its certainly a very slow improvement.

As this cohort grows, so too does the global effort to investigate how SARS-CoV-2 causes such symptoms. The picture so far remains somewhat puzzling. Autopsy studieswhich have been limitedhave found clear signs of damage in dozens of brains of COVID-19 patients. Although traces of the virus have been reported in some brain specimens, in many cases it is nowhere to be found. While the question of whether SARS-CoV-2 directly infects the brain remains unresolved, researchers are exploring other mechanisms whereby it could affect the human brain.

I think all of us probably . . . would agree that there is no overwhelming infection of the brain, notes Avindra Nath, a neurovirologist at the National Institute of Neurological Disorders and Stroke. If there is, its a very, very miniscule amount. That cannot explain the pathology that we see. It has to be something more than that.

An electron microscope image depicting a section of a ciliated cell in a COVID-19 patients olfactory mucosa, where researchers found intact SARS-CoV-2 particles (stained in red) inside cells

Michael Laue/RKI & Carsten Dittmayer/Charit

Early in the pandemic, some researchers worried that SARS-CoV-2 could be gaining access to the brain and represent a neurotropic virus, McNamara says. That would offer an obvious hypothesis for some of the neurological symptoms observed, while also posing complex questions around how to therapeutically target pathological processes in the brain. And after all, the genetic material of SARS-CoV-1 and MERS-CoV have been spotted inside human brains, and even common cold-causing coronavirus proteins arecuriously, given that they rarely lead to neurological symptomscommon in autopsied brains, adds Helena Radbruch, a neuropathologist at the Charit hospital in Berlin.

Yet the first brain autopsies of COVID-19 patients didnt find much SARS-CoV-2 RNA, let alone viral protein. In a September study of 18 COVID-19 patients with neurological symptoms who died in hospitals last April, Mukerji and her colleagues found very low levels of RNAthe source of which is a mysteryin only five of the patient brains, and no signs of viral protein. Because the low RNA concentration seems out of proportion to the profound deficits that people are experiencing, she says, Id be extremely surprised [if] the majority of cases where people are having neurological symptoms are due to direct viral invasion.

By the time COVID-19 patients die, most virus in the lung has often already been cleared, and that might be the case for the brain too.

In a more recent postmortem analysis of 18 patients published in the New England Journal of Medicine, Nath and his colleagues couldnt find any evidence of the virus in the brain. However, an earlier study from researchers in Germany reported viral protein in the cranial nerves and isolated brainstem cells in 21 of 40 patients examined postmortem. Viral protein that has somehow reached the central nervous system typically elicits an immune response, Mukerji notes, but its presence in the German study didnt correlate with the severity of neural inflammation the team observed.

Whatever viral protein is doing inside the brain, Radbruch and her colleagues assert that it is indeed finding its way there. In an autopsy study published in November in Nature Neuroscience, they propose that the virus could get into the brainstem through the nose. Based on detailed autopsy analyses from 33 COVID-19 patients, they discovered intact coronavirus particles in supporting cells of the olfactory mucosa at the roof of the nose, along with evidence of active replication in the tissue. Perhaps viral replication destroys those cells, and/or induces inflammation, which could help explain the frequent loss of taste and smell at the start of SARS-CoV-2 infections, notes Charit neuropathologist Frank Heppner, a coauthor of the study. The virus could then work its way into the olfactory bulb, a hub for processing sensory information, and via specific cranial nerves into the brain. Indeed, they observed evidence of viral RNA in these tissues as well as viral RNA and protein inside cells in the medulla oblongata in the brainstem, and in other structures such as the cerebellum, hinting that the virus could be using multiple routes of entry into the brain.

Nevertheless, Radbruch and Heppner agree that the extent of SARS-CoV-2s infection pales in comparison to that of fellow RNA viruses such as rabies, which is devoted to infecting brain tissue. SARS-CoV-2 is more of an incidentally neurotropic virus, likely getting into the brain by accident, Heppner says. Notably, in the brainstem they only found viral protein inside endothelial cells that make up the lining of blood vesselsthe blood-brain barrierand not inside neurons. That could be due to difficulties detecting the virus inside neurons, or could indicate that it doesnt infect neurons. In contrast to endothelial cells, which have an abundance of ACE2, the molecular doorways SARS-CoV-2 uses to enter cells, neurons tend not to have ACE2 receptors.

Still, the jurys still out on whether SARS-CoV-2 infects the brain, notes Eric Song, an immunobiologist at Yale University who recently completed his PhD in immunologist Akiko Iwasakis lab there. He points to their recently published study on brain organoid models, which suggests that its possible for SARS-CoV-2 to infect and exert pathological effects in neural tissue. Plus, postmortem samples are limited in number, only show the final picture of a disease, and, by necessity, reflect what happens in just the sickest patients. By the time COVID-19 patients die, most virus in the lung has often already been cleared, and that might be the case for the brain too, Song says.

In a recent preprint, he and his colleagues couldnt find viral RNA in the brain-engulfing cerebrospinal fluid (CSF) of six living COVID-19 patients with neurological symptoms. But interestingly, they did find B cells and antibodies in the CSF, and not just ones that target SARS-CoV-2, but also ones that target the bodys own proteins, including components of neurons. What this finding means is unclear, but it adds to a string of findings of body-attacking immune machinery in COVID-19. The looming question now, Song says, is whether this is an enriched process in [COVID-19] or if its a process that occurs with the same magnitude in other viral diseases.

Magnetic resonance microscopy of the medulla in an autopsied COVID-19 patient. Yellow arrows indicate hypointense regions (dark areas that are possibly a sign of local bleeding) and red arrows signify hyperintense areas (bright patches sometimes indicating immune cell presence)

Myoung-Hwa Lee et al.

While the evidence of SARS-CoV-2 inside human brains remains murky, autopsy studies have revealed a range of recurrent neuropathological features in hospitalized COVID-19 patients. Pathologists have frequently found localized hypoxic damage caused by a lack of oxygen and associated infarcts (or ischemic strokes), and less commonly, signs of bleeding in the brain, as well as some inflammationin some cases a severe inflammation known as acute disseminated encephalomyelitis. What exactly causes these pathologies is unclear, but scientists have some suspicions about contributing factors.

For instance, blood clotswhich COVID-19 patients are prone to developcould create blockages that restrict blood supply to neural tissue, explaining the observed mini strokes, Song says. The difficulty in getting enough oxygen through damaged lungs probably also makes patients more vulnerable to hypoxic brain damage. Systemic hypoxia, in turn, could result in neurological symptoms, but in general, its hard to say how pathologies discovered in autopsies are connected to clinical symptoms observed in patients, Mukerji adds in an email, as neurological exams arent often conducted when patients are hospitalized.

The immune response to the virus could also explain some neurological complications. Perhaps the exuberant flush of proinflammatory cytokines in the bodys periphery could cause inflammatory cytokines within the brain to be more active and cause inflammation [there], McNamara suggests. Interestingly, the Charit neuropathologists recent paper also found signs of inflammation and hordes of highly activated microglial cellsbrain-resident immunological defendersthat could feasibly be the result of a local or peripheral immune overactivation, Heppner hypothesizes. In turn, this could perturb neuronal function, and help explain certain COVID-19 encephalopathy symptoms, such as agitation, confusion, excessive sleepiness, and comas. Some patients, for instance, have problems weaning from ventilationthey do not wake up, and so far, we do not really understand why, Radbruch says.

Curiously, some patients also exhibit signs of microscopic damage to the small blood vessels in their brains, as evidenced in Nath and his colleagues recent brain autopsy study. The SARS-CoV-2positive subjectswho were obtained from New York Citys chief medical examiners officerepresent a unique patient cohort, most of them having died suddenly. Some had been found dead in nursing homes or in the subway, Nath says. In 10 of 13 patient brains examined under a high-resolution MRI scanner, the team noticed patches that appeared unusually bright or darkthe latter likely signifying signs of bleeding. Scrutinizing those areas, which sometimes included the olfactory bulb, the team found evidence of damaged blood vessel walls. And wherever blood vessels were damaged, protein staining revealed leakage of fibrinogena blood coagulation protein whose presence in the brain is associated with various neurological disordersinto neural tissue. Clustering around those sites they found macrophages and sometimes also activated microglia and T cells.

A plausible hypothesis is that some of those immune cells attack the endothelial cells that line the blood vessels, a cell type that SARS-CoV-2 is known to infect. Naths study didnt find any evidence of that, but at least thats one way to explain it, he says. And maybe thats whats causing the leakage. Then once you get the fibrinogen in the brain, you can incite more inflammation there . . . so it keeps building up a spiral.

He and his team also discovered signs that shine light on the patients sudden deaths. Assuming the patients died of cardiac dysfunction, they examined the nuclei in the base of the brainstem involved in the control of breathing. There, they spotted macrophages clustering around those neurons, a possible sign of neuronophagia, in which phagocytes devour unhealthy neurons. These respiratory centers and some of these other brainstem nuclei are impaired in their function, Nath says. Its hard to say how generalizable these findings are among COVID-19 patients, but I think its quite possible that some of these long-term symptoms that people have may be related to some of these things. Along with other researchers, hes working on a series of studies in long hauler patients to find out.

Its unlikely that one mechanism of neurological effects will fit all patients. Finding out what causative processes are unfolding in individuals will require integrating different techniques and many more brain autopsies, of which there have been only around a few hundred reported so far, largely due to a shortage of specialized equipment and labs to conduct them, Nath says. It will also require some sorting of what is currently a hodgepodge of neurological symptomsfor example, by establishing diagnostic criteria of post-COVID-19 syndrome and defining what acute versus chronic symptoms are, Mukerji adds.

She says she hopes that these studies will also help those with neurological conditions caused by other infections. There are a variety of people whove had [viral] infections [such as] Ebola or West Nile, who have said that they have cognitive complaints, brain fog, and that theyre disabledand its largely fallen on some deaf ears, she says. I would be surprised if the world does not take up this discussion much more scientifically than it has done in the past [and] try to understand if we can develop . . . some sort of diagnostic, and then some sort of therapeutic agent to help what is now going to be a large percentage of the worlds population.

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Neurologists test novel compound for lung and brain injury in severe COVID-19 patients – Newswise

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Newswise Neurologists are researching whether a novel immunomodulatory treatment, OP-101, can dampen lung and brain injury in hospitalized COVID-19 patients through a clinical trial at The University of Texas Health Science Center at Houston (UTHealth).

OP-101 is an investigational compound developed byAshvattha Therapeuticsto selectively attack the proinflammatory macrophages and microglia, which are the immune cells responsible for hyperinflammation, lung injury, and multi-organ failure caused by infections.

We see this type of hyperinflammation in a number of neurological disorders, including Parkinsons and Alzheimers disease, saidAaron Gusdon, MD, an assistant professor in the Vivian L. Smith Department of Neurosurgery at McGovern Medical School at UTHealth and principal investigator of the Houston site of the study. Now were seeing the same activation of the innate immune system in COVID-19 patients that drives production of proinflammatory cytokines, which can contribute to patients becoming rapidly critically ill. OP-101 has shown to robustly suppress hyperinflammation in a number of different disorders, so were investigating if this targeted approach can help patients with severe cases of COVID-19 as well.

Unlike single agent approaches, like antibodies, that address only one pathway, the treatment is intended to seek out and selectively shut down cells that are proinflammatory and restore the macrophages to a normal state.

The hope is that since it only targets the activated component of the innate immune system, it will have fewer side effects and less risk of a concurrent infection compared with some steroids and antibodies that broadly suppresses the whole immune system, said Gusdon, a neurologist with UTHealth Neurosciences.

In COVID-19 patients, we know the lungs and sometimes the brain become severely inflamed, saidLouise McCullough, MD, PhD,professor and Roy M. And Phyllis Gough Huffington Distinguished Chair in the Department of Neurology at McGovern Medical School and co-investigator of the OP-101 Houston site. Were seeing that trend play out in the long-hauler patients, as the inflammation can lead to long-term symptoms like confusion, fatigue, and depression. Were interested to see if selectively targeting the activated cells in the lungs, blood, and brain, can help dampen the cytokine storm and possibly prevent the consequences of lung and brain injury for these patients down the road. McCullough is also the co-director of UTHealth Neurosciences and chief of the Neurology Service at Memorial Hermann-Texas Medical Center.

McCullough is treating patients with neurological long-hauler symptoms at theUT Physicians Post-COVID-19 clinic, which is part of the UTHealth COVID-19 Center of Excellence and was the first post-coronavirus clinic in Houston.

The Phase II trial, called PRANA, is taking place at Memorial Hermann-Southwest and Memorial Hermann-Memorial City, along with several other sites across the country.

Were proud to offer some of the most innovative care not only to patients in the Texas Medical Center, but in surrounding sites as well, McCullough said.

At the Houston site, seven patients have been enrolled so far, and researchers are seeking two to four more. The national study will enroll approximately 24 patients.

Patients will be randomized to one infusion of OP-101 or placebo, in addition to standard-of-care therapy. Researchers will evaluate whether the treatment reduced inflammation, improved fever and oxygenation, and reduced the number of days without a ventilator, or time in the intensive care unit.

This research builds on a strong foundation of COVID-19 neurological research that McCullough andH. Alex Choi, MD, have built since the start of the pandemic.

Were a good fit to be on the front lines of coronavirus research because in addition to being neurologists, were also intensivists, said Choi, associate professor and vice chair ad interim for neuro critical care with McGovern Medical School, and a neurologist at UTHealth Neurosciences. Were interested in how systemic changes like sepsis and respiratory failure impact long-term cognitive functioning. We have established a prospective longitudinal study of COVID patients to understand how severe systemic inflammation can cause brain injury and long-term symptoms. We need to be part of the solution and understand how coronavirus affects patients long-term. Choi is also the director of neurocritical care for Memorial Hermann Health System and director of the neuroscience intensive care unit at Memorial Hermann-TMC.

For more information about the PRANA Phase II study, call 713-500-UTHN (8846) or visitclinicaltrials.gov.

Media inquiries: 713-500-3030

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Neurologists test novel compound for lung and brain injury in severe COVID-19 patients - Newswise

Diversity, Equity and Inclusion | Ohio State Medical Center – Wexner Medical Center – The Ohio State University

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The Ohio State Department of Neurology wants to stay connected to the community!

Please follow us on social media. Keep up-to-date on our efforts to promote greater diversity.

Interested in a career at Ohio State? Consider joining our department as well. You'll find current job listings here.

In the Department of Neurology, we value different perspectives and how each person can drive discussion and new improvements that we may have never considered individually. We strive to support a diverse, talented workforce that is truly inclusive. We recognize the value of broad perspectives and how varied characteristics and life experiences enrich our work and learning environment.

Formally writing our goals for diversity, equity and inclusion, holds us accountable. It shows our serious intent and keeps our efforts centered on what we want to accomplish now and in the future.

"The Ohio State University Wexner Medical Center Department of Neurology is committed to the values of diversity, equity and inclusion. We uphold these values by embracing the diversity of all of our employees, creating a supportive environment of professionalism and success. We strive to recruit and retain a diverse group of faculty and staff who can fully develop their talents through accessing equal and all opportunities for growth. We enhance our understanding of these issues by researching and devising strategies to eliminate health disparities among groups of patients with neurological disorders from different ethnic, racial and socioeconomic backgrounds. We believe that the values of diversity, equity and inclusion are essential to achieving excellence in our academic mission and in patient care."

Talk is a start, but action is what proves how seriously we take our commitment to change. Our department not only has a formal plan in place, but we are taking the steps necessary to continue ongoing progress.

Department activities

Medical center and College of Medicine recognition

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Cell discovery could lead to future treatments for neurological disorders – 6 On Your Side

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Researchers are hoping a new cell discovery will lead to strides when it comes to future treatments for degenerative neurological disorders like ALS and multiple sclerosis.

"If this translates to the clinic and it actually is successful, it'll be a game-changer," said Dr. Benjamin Segal.

For more than 30 years as a neurologist, Dr. Segal has watched patients slowly succumb to disorders like multiple sclerosis. But now, he and a team at Ohio State University's Wexner Medical Center say they've discovered a new type of immune cells tested in mice, that they hope will lead to new treatments.

The treatments will be not only for those with degenerative neurological disease, but also for people suffering from brain or spinal cord damage, and even stroke.

"What we're all pursuing is better ways to make our patients function better and to reclaim lost skills and abilities," said Dr. Segal.

He says the cell tested in mice can save dying nerve cells and stimulate re-growth when nerve fibers are damaged. Dr. Segal says they've also identified an immune cell line in humans with similar characteristics that promotes nervous system repair.

The next step is to harness this cell in the lab. Researchers are hoping to one day be able to inject the cells into patients.

"There's really a tremendous potential with this new approach."

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Newly discovered immune cell offers path to treating ALS, MS and other brain diseases – FierceBiotech

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Neurological diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) cause damage to nerve fibers that cant be reversed. Now, scientists at Ohio State University and the University of Michigan have discovered an immune cell they believe could be harnessed to partially reverse this damage and slow MS, ALS and other neurodegenerative disorders.

By studying mouse models, the researchers discovered a new type of white blood cell known as a granulocyte. Its similar to a neutrophilan infection-fighting white blood cellbut it secretes growth factors that helped axons of the central nervous system regenerate, the team reported in the journal Nature Immunology. They identified a subset of human immune cells with similar properties, they said.

The ability of this subset of granulocyte to stimulate the regrowth of severed nerve fibers is "really unprecedented," said Benjamin Segal, M.D., professor and chair of neurology at Ohio State College of Medicine and co-director of the Wexner Medical Center's Neurological Institute, in a statement. "In the future, this line of research might ultimately lead to the development of novel cell based therapies that restore lost neurological functions across a range of conditions."

RELATED: How the brain's immune cells could guide treatment of neurodegenerative diseases

The team observed that the newly discovered granulocytes were similar to immature neutrophils. To test whether the granulocytes might have therapeutic powers, the researchers injected them into mice with injured optic nerves or broken nerve fibers. Those animals regrew nerve fibers, while mice injected with mature neutrophils did not.

The notion that immunotherapy might offer solutions to brain diseases is a popular one in neurological research. Last year, Stanford University researchers described a subpopulation of CD8 T cells that could be boosted with a peptide to relieve MS symptoms in mice.

And just last month, researchers led by Mount Sinais Icahn School of Medicine reported that immune cells called microglia can tamp down excessive neuron activity in diseases such as Alzheimers and Huntingtons. Targeting microglia in neurodegenerative diseases is also the focus of startup Tranquis Therapeutics, which launched with $30 million in capital this summer.

The next step for the Ohio State and University of Michigan researchers is to collect the neuro-enhancing granulocytes they discovered and figure out how to enhance them in the lab. Ultimately, they hope to determine whether the cells could be injected into patients to reverse damage to the central nervous system.

Such an immunotherapy could be useful not just for treating diseases like MS and ALS, but also for treating traumatic injuries to the brain and spine, they suggested.

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Newly discovered immune cell offers path to treating ALS, MS and other brain diseases - FierceBiotech

Global Impact of Covid-19 on Interventional Neurology Device Market to Record Significant Revenue Growth During the Forecast Period 20202025 |…

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Interventional-Neurology-Device-Market

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Detailed TOC of Interventional Neurology Device Market Report 2020-2025:1 COVID-19 Impact on Interventional Neurology Device Market Overview1.1 Product Definition and Market Characteristics1.2 Global Interventional Neurology Device Market Size1.3 Interventional Neurology Device market Segmentation1.4 Global Macroeconomic Analysis1.5 SWOT Analysis2 COVID-19 Impact on Interventional Neurology Device Market Dynamics2.1 Interventional Neurology Device Market Drivers2.2 Interventional Neurology Device Market Constraints and Challenges2.3 Emerging Market Trends2.4 Impact of COVID-192.4.1 Short-term Impact2.4.2 Long-term Impact3 Associated Industry Assessment3.1 Supply Chain Analysis3.2 Industry Active Participants3.2.1 Suppliers of Raw Materials3.2.2 Key Distributors/Retailers3.3 Alternative Analysis3.4 The Impact of Covid-19 From the Perspective of Industry Chain4 Interventional Neurology Device Market Competitive Landscape4.1 Industry Leading Players4.2 Industry News4.2.1 Key Product Launch News4.2.2 M&A and Expansion Plans5 Analysis of Leading Companies5.1 Company A5.1. Company Profile5.1.2 Business Overview5.1.3 Interventional Neurology Device market Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.1.4 Interventional Neurology Device market Products Introduction5.2 Company B5.2.1 Company Profile5.2.2 Business Overview5.2.3 Interventional Neurology Device market Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.2.4 Interventional Neurology Device market Products Introduction6 Interventional Neurology Device Market Analysis and Forecast, By Product Types6.1 Global Interventional Neurology Device Market Sales, Revenue and Market Share by Types (2015-2020)6.2 Global Interventional Neurology Device Market Forecast by Types (2020-2025)6.3 Global Interventional Neurology Device Market Sales, Price and Growth Rate by Types (2015-2020)6.4 Global Interventional Neurology Device Market Revenue and Sales Forecast, by Types (2020-2025)7 Interventional Neurology Device Market Analysis and Forecast, By Applications7.1 Global Interventional Neurology Device Market Sales, Revenue and Market Share by Applications (2015-2020)7.2 Global Interventional Neurology Device Market Forecast by Applications (2020-2025)7.3 Global Interventional Neurology Device Market Revenue, Sales and Growth Rate by Applications (2015-2020)7.4 Global Interventional Neurology Device Market Revenue and Sales Forecast, by Applications (2020-2025)Continued

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New Epilepsy Drugs, Expanded Therapy Options: How the… : Neurology Today – LWW Journals

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Article In Brief

Newly-approved epilepsy drugs and other therapies in development may be effective in treating cases that were once resistant to treatment, epileptologists say. But while experts said they appear promising, they also were not ready to skip older options for which more data are available.

New epilepsy medications and other products in the pipeline may soon start to chip away at the stubborn one-third of epilepsy cases that are resistant to treatment, epileptologists told Neurology Today in a series of telephone interviews. What's more, they said, the new therapies may also offer the possibility of seizure control with fewer side effects.

Among the recent advances in epilepsy care are a much-anticipated new drug for uncontrolled focal seizures in adults, an added indication approved for the first cannabidiol (CBD)-based medication for children with uncontrolled seizures associated with several rare conditions, and rescue medications in the form of nasal sprays.

Epilepsy researchers said the new drugs and others in development will begin to fill niches in both adult and pediatric epilepsy care and expand treatment options for some patients.

There have been dramatic changes in the past few years, and there are even more dramatic ones on the horizon, said James W. Wheless, MD, FAAP, FAAN, professor and chief of pediatric neurology at the University of Tennessee Health Science Center.

But Dr. Wheless said that in spite of the progress achieved in recent years in developing new treatments, seizure freedom rates haven't improved dramatically. We haven't found the Holy Grail yet.

Researchers anticipate that some genetic-based therapies will likely be in the next wave of epilepsy treatments. The general approach is to target underlying genetic causes of epilepsy rather than treating the symptomseizures.

We have come to understand that epilepsy has many causes, said Dr. Wheless, who is working with companies that are developing therapies that would target the SCN1A gene, which is implicated in Dravet syndrome.

The goal is to modify the one good copy of the gene that these patients' have, which will correct the channel defect, he said. This should restore normal brain function and dramatically improve the symptoms, one of which is uncontrolled seizures.

Some of the newer treatment options include cenobamate (Xcopri), which was approved by the US Food and Drug Administration (FDA) in November 2019 as an adjuvant therapy for treatment-resistant partial-onset seizures in adults. The experts said the drug is a noteworthy addition, but it is too soon to say whether it will be a game changer for many patients.

Gregory L. Krauss, MD, professor of neurology at Johns Hopkins University who was a co-investigator for the drug's clinical trials, said that in two placebo-controlled regulatory trials, about 60 percent had marked seizure reduction (greater than 50 percent) and 20 percent became seizure free, despite having highly treatment-resistant epilepsy.

Dr. Krauss said that two-thirds of his 49 patients have continued cenobamate treatment for up to eight years, and 12 achieved long-term seizure freedom. The drug's mechanism of action is not fully understood, though its strong efficacy may relate to its activity as a selective sodium channel blocker, preferentially inhibiting a persistent sodium current, Dr. Krauss said. It also may enhance release of the gamma aminobutyric acid inhibitory neurotransmitter.

Several patients in clinical trials developed serious allergic reactions with DRESS syndrome (drug reaction with eosinophilia and systemic symptoms). In a subsequent open-label safety study, more than 1,300 patients started treatment using very low, slowly titrated initial doses and they did not develop the syndrome.

Dr. Krauss said the while cenobamate was approved for patients with intractable epilepsy, it may have broader potential.

The question is how patients with less refractory epilepsy than those enrolled in the placebo-controlled trials will do and so far, based on the large safety study results and our initial clinical use, cenobamate looks pretty effective, he said.

A CBD therapy (Epidiolex), the first FDA-approved medication derived from marijuanawas approved in July for a new indicationseizures associated with tuberous sclerosis complex. The therapy was approved in 2018 to treat seizures related to two other rare conditions, Lennox-Gastaut syndrome and Dravet syndrome.

While there have been dramatic stories in the media of young patients whose relentless seizures were helped by the therapy, clinical experience with cannabidiol is still new.

I've had some real success with a handful of patients who have drug-resistant epilepsy, said Shawniqua Williams Roberson, MD, assistant professor of neurology at Vanderbilt University Medical Center. Her enthusiasm, however, has been tempered by the drug's side effects, including significant diarrhea and somnolence, that her patients have experienced.

Dr. Williams Roberson said that in general, and not just with cannabidiol, she tends to adopt new medications into her practice slowly because she wants to wait for post-approval reports that may provide a fuller picture of side effects and efficacy.

In general, I don't see the new drugs as first-line agents because we have a number of agents that are quite reliable and likely to work, she said. Why expose the patient to the unknown potential for side effects of a new drug when it does not offer a substantially better chance of seizure freedom than others I have yet to try?

But some newer therapies are worth trying for certain patients, some neurologists said. Diazepam nasal spray (Valtoco) and midazolam nasal spray (Nayzikam) are rescue medications approved for the acute treatment of seizure clusters. They are considered a welcome alternative to rectally-administered diazepam.

Dr. Wheless said the rescue nasal sprays can be life-changing for families who fear venturing very far from home because their child might have seizures and not be near a hospital.

It really empowers the families and can change the quality of life for the entire family, he said.

Fenfluramine (Fintepla) was approved by the FDA in June for the treatment of seizures associated with Dravet syndrome. The drug comes with a warning that it can cause valvular heart disease and pulmonary arterial hypertension.

Jacqueline A. French, MD, FAAN, professor of neurology at NYU Langone Health, said the excitement around new and emerging treatments for epilepsy was evident during a conference in August that focused on new therapies in the research and development pipeline.

The pipeline for epilepsy therapies is just exploding, which is a wonderful thing to see, said Dr. French, who is chief medical officer for the Epilepsy Foundation, which sponsored the conference. There is a renewed enthusiasm for tackling the unmet needs in epilepsy.

She said emerging therapies are likely to include disease-modifying drugs that target genetic underpinnings of disease.

Most therapies up to now have been symptomatic treatments. They can stop seizures, but they leave the disease unchanged, she said.

Dr. French coauthored an article published in Epilepsy Currents in March that advocated for changing the name used to describe drugs from antiepileptic drugs (AEDs) to antiseizure medicines (ASMs).

Using the term antiepileptic to describe these compounds is misleading because it suggests an action on the epilepsy itself, she wrote along with Emilio Peruca, MD, PhD, of the University of Pavia in Italy.

Using appropriate terminology is especially important at a time when innovative treatments targeting the development of epilepsy and its comorbidities are being actively pursued, the article said.

The International League Against Epilepsy is considering the issue, Dr. French said.

For now, much of the attention in epilepsy care is expected to be on cenobamate. Dr. French, who participated in a randomized phase 2 trial and the open-label testing of the drug conducted primarily to look at safety concerns, said it is too soon to make any firm conclusions about the drug's potential, noting that it will take time for more data on efficacy, safety and tolerability to emerge from clinical use.

Sheryl R. Haut, MD, professor of neurology at Albert Einstein College of Medicine and director of the Adult Epilepsy Program at Montefiore Medical Center, said that in addition to pharmacological interventions for epilepsy, surgical treatments such as thermal ablation have also expanded. Surgery is still seen as the ideal option for many patients with intractable seizures. She said there is also an important role in epilepsy care for alternative approaches, such as using meditation or mindfulness to reduce stress.

Dr. Haut, who participated in clinical testing of both cenobamate and cannabidiol, said she and her colleagues who work in epilepsy centers continue to have a healthy respect for the efficacy and experience with the older drugs. Insurance coverage also influences prescribing decisions, she added, particularly since many older drugs are available in cheaper generic forms.

Changing someone who is seizure-free to another medicine ends up being a big decision, she said, even if the person has some milder side effects. Some drug changes, involving switching from a potentially teratogenic drug, are necessitated by a female patient's desire to become pregnant.

Dr. Haut said that while seizure freedom is the goal for which we aim, in tailoring a patient's treatment, there is a long list of positive outcomes that have to also be our goals.

The impact of epilepsy is far-reaching, she said, noting that improvements in quality of life are a measure that doesn't necessarily get enough attention.

Dr. Haut has received consulting fees from Alden Health. Dr. Williams Roberson has received fees for an in-kind gift of a dinner from LivaNova. Dr. French receives NYU salary support from the Epilepsy Foundation and for consulting work and/or attending scientific advisory boards on behalf of the Epilepsy Study Consortium for Aeonian/Aeovian, Anavex, Arvelle Therapeutics, Inc., Athenen Therapeutics/Carnot Pharma, Axovant, Biogen, BioXcel Therapeutics, Blackfynn, Cerebral Therapeutics, Cerevel, Crossject, CuroNZ, Eisai, Encoded Therapeutics, Engage Therapeutics, Epiminder, Epitel, Fortress Biotech, Greenwich Biosciences, GW Pharma, Ionis, Janssen Pharmaceutica, Knopp Biosciences, Lundbeck, Marinus, Merck, NeuCyte, Inc., Neurocrine, Otsuka Pharmaceutical Development, Ovid Therapeutics Inc., Passage Bio, Pfizer, Praxis, Redpin, Sage, SK Life Sciences, Stoke, Sunovion, Supernus, Takeda, UCB Inc., Xenon, Xeris, Zogenix. She has also received research grants from Biogen, Cavion, Eisai, Engage, GW Pharma, Lundbeck, Neurelis, Ovid, Pfizer, SK Life Sciences, Sunovion, UCB, Xenon and Zogenix as well as grants from the Epilepsy Research Foundation, Epilepsy Study Consortium, and NINDS. She is on the editorial board of Lancet Neurology and Neurology Today. She has received travel reimbursement related to research, advisory meetings, or presentation of results at scientific meetings from the Epilepsy Study Consortium, the Epilepsy Foundation, Arvelle Therapeutics, Inc., Biogen, Cerevel, Engage, Lundbeck, NeuCyte, Inc., Otsuka, Sage, UCB, Xenon, Zogenix.

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Falls Are Associated with Markers of Neurodegeneration in… : Neurology Today – LWW Journals

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Cognitively normal older adults who experienced falls also had markers of neurodegeneration, such as amyloid uptake and smaller hippocampal volume on imaging measures. The research suggest falls in cognitively normal older adults may serve as a behavioral biomarker of preclinical Alzheimer's disease.

Falls in cognitively normal older adults could potentially serve as a behavioral marker of preclinical Alzheimer's disease (AD), researchers suggested in a paper published September 15 in the Journal of Alzheimer's Disease.

The findings were based on a cross-sectional analysis of structural and functional MRI and PET measures of amyloid uptake, brain volumetrics, and global resting state-functional connectivity (rs-fc) intra-network signature on MRI in cognitively normal adults who kept a calendar of falls over a one-year period. (The global rs-fc intra-network signature measures connectivity between brain networks when subjects are in a resting state.) The researchers compared imaging data with similar measures from preclinical AD participants who had not recorded falls.

Falls in cognitively normal older adults correlated with markers of neurodegeneration, such as amyloid uptake and smaller hippocampal volume (p=0.004). Amyloid-positivity alone did not lead to more falls, however. Rather those who had increased amyloid and more disrupted connectivity (on rs-fc MRI), particularly in the somatomotor and primary sensory networks, had a greater risk of more falls.

Not everyone who has a fall is going to develop AD, but it is something that you should be asking about among patients; we can't just think about memory complaints alone, said study author Beau M. Ances, MD, PhD, MS. FAAN, the Daniel J. Brennan, MD professor of neurology at Washington University in St. Louis, MO.

Clinicians should inquire about other physical changes that individuals are experiencing. This information can help clinicians address the individual's needs, Dr. Ances said.

We work with a great team of occupational therapists, and if individuals are having repeated falls, if they are having difficulties getting in and out of the bathroom or the tub, we can assess their home environment. We can do certain kinds of things so that individuals can stay in their homes and be comfortable and be safe, and that can make a huge difference for the family as well as the individual who may be developing AD, he added

To look closely at the association between neurodegeneration and falls, the study team evaluated 83 cognitively normal individuals who had been assessed by the Clinical Dementia Rating scale. The research used tailored calendar journals to collect data on falls on these individuals over a one-year period.

We verified falls both with the individual as well as other caregivers who could report and be a collateral source for helping us evaluate that, Dr. Ances explained.

Within two years of falls, the participants underwent structural functional MRI and amyloid PET. Using standard cutoffs, cognitively normal participants were dichotomized by amyloid PET status.

The team compared the relationship between the global rs-fc intra-network signature and amyloid accumulation among those who did and did not fall among amyloid-positive participants. In addition to having a smaller hippocampal volume, those who fell had a negative correlation between global rs-fc intra-network signature and amyloid uptake (R = -0.75, p=0.012).

This means that within those individuals who had falls a loss of connections within the brain was associated with increased amyloid uptake, Dr. Ances told Neurology Today.

The researchers also found a trend toward a positive correlation between global rs-fc intra-network signature and amyloid uptake among preclinical AD participants who didn't fall (R = 0.70, p=0.081).

It's really the presence of amyloid and tau that is really starting to lead to changes in the brain, which are then reflected in those functional connections in the brain, Dr. Ances said. Because those functional connections are no longer as strong between these various brain networks, individuals may be more susceptible to having falls. This tells us that falls could be an important evaluation tool for individuals, he added.

More research is underway in which the investigators are going into homes to evaluate these patients, noted Dr. Ances. We are looking at these falls and the trajectories of these patients longitudinally, he said. We will continue to use these biomarkers, and other markers at home, to report on how they are doing in the home setting. That's where our next efforts are focused.

This is a very useful and important cross-sectional study connecting neurodegeneration to factors other than cognition, said Sudha Seshadri, MD, FAAN, a professor of neurology and founding director of the Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases at the University of Texas Health Science Center in San Antonio.

Obviously, we have achieved an understanding of amyloid-related neurodegeneration in the brain. And the most obvious and distressing part of AD is the loss of memory and thinking, but when the brain has changes, it affects more than just cognition, she added.

Falls are the other big problem with older adults, and because falls were often dealt with by other physicians and geriatricians, we have tended to think of them as a related to muscle strength and bone density, Dr. Seshadri said. It is related to those things, but there is [also] a very important neurologic component to solve. This study highlights the importance of understanding that association in terms of its biology. It may help us perhaps better prevent falls, and potentially use something like a simple gait test as a marker, Dr. Seshadri told Neurology Today.

I'm excited by this study as I think it recognizes the need to look at the physical and other aspects of amyloid-related neurodegeneration as well as other types of neurodegeneration, Dr. Seshadri said.

Douglas W. Scharre MD, CMD, FAAN, professor of clinical neurology and psychiatry in the Ohio State University Wexner Medical Center, who was not involved in the study, agreed. Common sense may tell us that the more your brain is damaged by AD, the more likely it will not work as well to prevent falls. This study looks at volume loss of the brain in particular areas and looks for loss in neural networks and connections between different parts of the brain to see if that is associated with increased falls, he said.

The findings suggests that the more advanced the preclinical disease, the more at risk they are for falling. Practically speaking, it is universally good practice to educate patients on fall prevention as eliminating any falls is worthwhile, Dr. Scharre added.

Dr. Scharre pointed out that this research team previously published work on falls in preclinical AD based on PIB amyloid PET and CSF tau-to-amyloid ratios and had previously associated increased amyloid in the brain with more falls. But this paper added functional and structural MRI to amyloid PET, he said.

The study was underpowered in proving the association between falls and AD because some of the other neurodegenerative dementias may not have been entirely captured, noted Kevin Conner, MD, a neurologist at the Texas Health Arlington Memorial Hospital and with Neurology Inpatient Physician Services, a Texas Health Physicians Group practice. Dr. Conner noted that the study duration was relatively short, and perhaps more positive findings would have been found with a longer duration.

Falls are difficult to assess because there can be many factors at play when a person falls, and just because a person falls doesn't mean they have AD, Dr. Conner noted. Falls may be related to a range of factors like peripheral neuropathies, amyotrophic lateral sclerosis, stroke, spinal cord injuries, or even vitamin deficiencies, Dr. Conner continued.

I think what this study tells me is that if you have a patient, who is having falls, and you have ruled out some of the other reasons behind the falls that you need to think about AD as a potential etiology for the fall itself. If you have a patient who is cognitively impaired and is falling, then it may be worth doing additional studies looking specifically looking for AD or for some of the other neurodegenerative dementias that can cause falls, like Lewy Body disease, frontotemporal dementia, or Parkinson's disease, Dr. Conner told Neurology Today.

Drs Ances and Conner reported no disclosures. Dr. Scharre disclosed relationships with Acadia, BrainTest, Biogen, InSightec, vTv therapeutics, Eisai, Eli Lilly, Biogen, Roche, AZTherapies, Biohaven, and Novartis. Dr. Seshadri disclosed relationships with Biogen.

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Women neurologists have become more prominent in leadership at the AAN by serving on committeesfrom 14 percent in 1997 to 36 percent in 2017. And significantly, their academic achievement improved when first and last authorship in Neurology were analyzed.

The last two decades have ushered in a growing number of women in neurology. Still, representation in positions of leadership, publication, and award appointments has often been far from equitable. A Neurology study published online ahead of print on September 15 found some encouraging trends in the recognition of women from recent years (between 2007 and 2017), based on data from US-based AAN members.

However, there is a lot more work to be done.

Given the large inequity prior to 2007, it will likely take until 2047 for women to reach 50 percent of US neurologist members, study author Janis Miyasaki, MD, MEd, FRCPC, FAAN, director of the Parkinson and Movement Disorders Program at the University of Alberta in Edmonton, Canada, told Neurology Today.

Despite this, we found that women have become more prominent in leadership at the AAN by serving on committeesfrom 14 percent in 1997 to 36 percent in 2017. And significantly, their academic achievement improved when first and last authorship in Neurology were analyzed.

The analysis showed that, while in 1997 and 2007 US female AAN members were equally as likely as male members to be first author on papers in Neurology, by 2017, women were more likely to have first authorship than men (p <0.001). Further, the rate ratio of a woman being a last author in a Neurology publication was 0.38 in 1997, but by 2017, it had grown to 1.06.

At the medical student level, as each year achieves a greater proportion of women in neurology, women medical students can see themselves as belonging to neurology. Each intervention [to improve representation] has an effect on other measures that we looked at in an almost endless cycle, Dr. Miyasaki said.

When you read articles written by women, you imagine that you could be an investigator or scientist. When you see women at the podium, you believe you could be there some day. My personal experience with the AAN has been that it was progressive when other organizations or institutions were not.

For a long time, the argument has been that the pipeline will solve all problems of women's participation, Dr. Miyasaki continued. But if we wait passively for the pipeline to fix everything, women will not progress.

Recognizing this, she said, the AAN has made a concerted effort to champion women in neurology, and the analysis shows these labors are beginning to pay off.

When I first started as a volunteer with the AAN in 1999, I was often the only woman on a committee or work group. And I was often the only person who was not White. When I look around the room now, I see many more individuals from varied backgrounds. This can only help make our organization stronger because we better represent the demographic in medicine and, hopefully, we will come to represent the demographic in society as a whole, Dr. Miyasaki said.

Using membership data from the AAN, Dr. Miyasaki and colleagues reported that in 1997, US male AAN members outnumbered US women 4:1; in 2007 and 2017, the ratio of US women to men increased to 1:2.3 and 1:1.5, respectively. Additionally, American Medical Association and the Accreditation Council for Graduate Medical Education data showed that while female medical students were less likely than male medical students to enter neurology residency programs in 1997, in 2007 and 2017, there was no significant difference between these groups.

And although there were fewer women receiving AAN awards in absolute terms, when analyzed proportionately, women were more likely to receive recognition awards in all years studied (1997, p=0.008; 2007, p<0.001; 2017, p<0.001), according to the analysis.

Dr. Miyasaki suggested that some of these improvements may stem from the growing trend of equity, diversity, and inclusion officers in departments of neurology across the country, as well as the AAN's leadership programs for women and those underrepresented in medicine (UIM).

In the leadership cohorts, there is a concerted effort to ensure that each class is representative of our membership in sex (women and men) and UIM, and thus ensure that women are better represented, she added.

Still, it is important to remember that the AAN is just one influencer in neurology and neuroscience, Dr. Miyasaki said. Universities, research institutes, granting agencies, and editorial boards have significant influence on attracting women into neurology and also supporting their careers. Until we see women in the highest positions in significant numbers as chairs of neurology departments, ordare we dreamdeans of medical faculties or presidents of universities, women will still have challenges in achieving equity and inclusion in their local institutions, she said.

Dr. Miyasaki noted that many AAN members are in community practices and should be asking the same questions of their own organizations and leadership.

The Neurology paper had some notable limitations, including its inability to examine ethnicity, gender identity, geographic location, or other factors that may result in marginalization of neurologists; its use of a single journal (Neurology) for authorship data; and its inclusion of US-only AAN members.

In the future, we should also examine the intersectionality of gender, gender minorities and ethnicity for these same metrics. Research shows that participating in education on this topic is not enough, she added; we need to examine what steps can change behaviorfor example, hiring more diverse faculty, choosing more diverse trainees, collaborating with those outside your usual research group.

Responding to the findings, neurology leadersall of whom were involved in the AAN's Gender Disparity Task Force Reportsaid the results were encouraging and further evidence of the importance of continuing to fight for representation of women, as well as other minority groups.

The most important takeaway from this article is that an inclusive and proactive approach to recognizing and identifying talent among women can lead to real change within an organization, whether it is a professional society like the AAN or a university, medical school, or neurology practice, said Nassim Zecavati, MD, MPH, FAAN, associate professor of neurology at Virginia Commonwealth University and director of epilepsy at the Children's Hospital of Richmond.

There has undoubtedly been a concerted effort by the AAN to ensure the Academy's leaders and publications reflect the diversity of its members. The breadth and growth of the AAN's leadership programs reflect this. However, there is much work left to be done as women make up a dismal 13 percent of health care CEOs in the United States (according to the Oliver Wyman Report), Dr. Zecavati emphasized.

In senior positions in academia and large health systems, she added, we continue to see the underrepresentation of women. It is incumbent upon organizations to scrutinize their leaders and ask, do these leaders reflect the diversity of our organization, both in terms of gender and ethnicity? If the answer is no, then concrete steps need to be taken to promote gender equity and parity in the organization.

Lynne P. Taylor, MD, FAAN, Alexander M. Spence Endowed Chair in Neuro-Oncology and clinical professor of neurology and neurologic surgery and medicine at UW Medicine, remembers in 1992, after Patty Murray was elected as the first female Senator from Washington State. It made an impression on her then and inspired her determination to become involved in the AAN, but, she said, couldn't see her way into what appeared to be an old man's society.

Dr. Taylor wrote a letter addressed to the Academy declaring, This is the year of the woman in politics and I think you need more female representation in the AAN. Without any connections to the organization, she never expected to hear back, but less than a week later she received a phone call from Robert C. Griggs, MD, FAAN, who was then the chair of the AAN's Education Committee.

I couldn't believe he was calling me. He said, how would you like to be involved? With that phone call, he put me on a committee, and I have been very involved in the AAN ever since.

The lesson, perhaps, is that you can't be who you can't see. She continued: When academies and organizations put their annual meeting together or decide who will give their annual lecture, they should always ask the question, Is it equitable?

Since the publication of a number of articles showing disparities in pay based on gender within medicine, there has been concern with the equity of professional achievement for women in medicine, Elaine C. Jones, MD, FAAN, a member of the AAN's Board of Directors, said.

With neurology showing some of the largest disparities in pay based on gender and subsequent research suggesting lower rates for awards to female neurologists compared to males, AAN leadership focused on this area. One important point that came up was that transparency was vital to understanding the issues and dealing with any discrepancies.

Dr. Jones said she was pleased to see the investigation by Dr. Miyasaki and colleagues, as well as the results. While there are some limitations to the conclusions, as pointed out in the article, the overall findings suggest that as of 2017 and within the AAN's scope of leadership roles, awards and publications, women are equal or even slightly ahead of men in these areas.

She added that these findings, though encouraging, will need to be monitored over time to ensure continuity. I would like to see similar investigations of other underrepresented groups, including by race, geographic location, and age, although these are harder factors to determine with this type of data analysis.

In the future, it will also be important to look at how gender roles in society factor into women's professional achievement, she said. It is well documented that women tend to be the caregivers for the family and so some women may be unable to pursue professional advancement due to these other demands on their time. Is there a selection bias for the type of women that are able to achieve these goals?

Due to loss of school and extracurricular participation, the current pandemic has created a need for one parent to be home more than in the past, Dr. Jones said. Women have borne the brunt of some of this and may have had to forego work opportunities that could lead to future professional advancement. It is important to continue to monitor these areas for impact in the future.

There is also the possibility telecommunication will encourage and allow more women and underrepresented groups to become involved, Dr. Taylor said.

It will likely take years to fully understand the effects of the pandemic on the workforce Dr. Zecavati agreed, but it is a very concerning possibility that women and minorities will be disproportionately affected.

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Study Finds Women Increasingly Represented in AAN... : Neurology Today - LWW Journals