Social isolation is associated with an increased risk of a cardiovascular event of more than 40%, and of all-cause mortality approaching 50%, new research suggests.

"These results are especially important in the current times of social isolation during the coronavirus crisis," Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.

The mechanism by which social isolation may boost risk for stroke, myocardial infarction, or death isn't clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Gronewold.

The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.

For this new study, researchers analyzed data from 4139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall (HNR) study. The randomly selected study group was representative of an industrial rural area of Germany, said Gronewold.

Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.

Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed).

They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.

Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. Over 300 (309) lacked social integration, defined by the lowest level on the social integration index.

Participants were asked annually about new cardiovascular events, including stroke and myocardial infarction. Over the follow-up period, there were 339 such events and 530 deaths.

After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio [HR], 1.44; 95% CI, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).

The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).

Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.

"Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile," commented Gronewold. "They seem to have a direct effect on these outcomes."

Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Gronewold.

The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Gronewold.

It's not yet clear why people who are socially isolated have such poor health outcomes, she added.

Gronewold has reported no relevant financial relationships.

Congress of the European Academy of Neurology (EAN) 2020. Abstract 2369. Presented May 22, 2020.

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Social Isolation Tied to Higher Risk of CV Events, Death - Medscape

New York, May 26, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Asia Pacific Rare Neurological Disease Treatment Market to 2027 - Regional Analysis and Forecasts by Indication ; Drug Type ; Distribution Channel ; Mode of Administration and Country" - https://www.reportlinker.com/p05894521/?utm_source=GNW Restraining factors, such as higher cost of rare neurological disease treatments likely to damage the growth of the market in the coming years.

On the other hand, artificial intelligence for the treatment of rare neurological diseases is expected to have a positive impact on the growth of the Asia Pacific rare neurological disease treatment market in the coming years.

A large group of rare diseases that have inefficient diagnoses and treatments are the neurological disease.These diseases target the nervous system, which include the brain, spinal cord, and all the nerves that run throughout the human body.

There is no surety regarding the onset of the diseases; some can strike during childhood, whereas others can affect even highly aged people.

In the world of medicine, rare neurological diseases represent significant burden on health systems in terms of disease diagnosis, treatment, and management.Some of the majorly observed rare neurological diseases comprises narcolepsy, amyotrophic lateral sclerosis, Alzheimers disease, multiple sclerosis, spinal muscular atrophy (SMA), Duchenne muscular dystrophy, and others.

According to a data published in neurological disorders report by World Health Organisation (WHO), most people with dementia are living in developed countries: by 2040, 60 percent in 2001 increased to an estimated 71 percent. Growth rates are not uniform; numbers are expected to rise by 100 percent in developed countries between 2001 and 2040, but by more than 300 percent in China, India and neighboring countries in South-East Asia and the Western Pacific.

Over the past few decades, various research and developmental works have been carried out pertaining to the diagnosis and management of rare neurological diseases.Advancements in healthcare systems and modernizing diagnostic systems are likely to enhance the screening operation for rare neurological diseases.

Additionally, increasing prevalence of rare neurological diseases is expected to drive the growth of the rare neurological disease treatment market during the forecast period.

In 2019, the Alzheimers disease accounted for the largest market share in the Asia Pacific rare neurological disease treatment market.Alzheimers disease is a progressive disease and a type of dementia, and the condition is characterized by eating and death of brain cells.

It is characterized by symptoms such as reduced thinking, memory loss, and lacking behavioural sense.These symptoms get worse over time and highly reduce the independently for daily routine.

The disease accounts for nearly 60% to 80% of all dementia cases.It is widely seen among the aging population.

The disease accounts for nearly 60% to 80% of all dementia cases. It is widely seen among the aging population. For instance, In 2012, Alzheimers Asia Pacific reports that prevalence of AD in China has been found to range between 7 per 1000 people to 66 per 1000 individuals.

In 2019, the biologics segment, held the most significant market share of the rare neurological disease treatment market by the drug type.This segment is also anticipated to be the fastest growing segment of the market in 2027, owing to the increasing neurological disorders, coupled with increasing robust hospital infrastructure and advancements in medicines, has enabled people for various treatments for the deadliest diseases.

Hence, the segment is anticipated to witness growth at a significant rate during the forecast period.

Some of the significant primary and secondary sources for cold plasma equipment included in the report are World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and National Institute of Health (NIH).Read the full report: https://www.reportlinker.com/p05894521/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Asia Pacific, the rare neurological disease treatment market, is anticipated to reach US$ 2,437.02 Mn in 2027 from US$ 1,225.38 Mn in 2019 -...

As case numbers of COVID-19 continue to rise around the world, we are starting to see an increasing number of reports of neurological symptoms. Some studies report that over a third of patients show neurological symptoms.

In the vast majority of cases, COVID-19 is a respiratory infection that causes fever, aches, tiredness, sore throat, cough and, in more severe cases, shortness of breath and respiratory distress.

Yet we now understand that COVID-19 can also infect cells outside of the respiratory tract and cause a wide range of symptoms from gastrointestinal disease (diarrhoea and nausea) to heart damage and blood clotting disorders. It appears that we have to add neurological symptoms to this list, too.

Several recent studies have identified the presence of neurological symptoms in COVID-19 cases. Some of these studies are case reports where symptoms are observed in individuals.

Several reports have described COVID-19 patients suffering from GuillainBarr syndrome. GuillainBarr syndrome is a neurological disorder where the immune system responds to an infection and ends up mistakenly attacking nerve cells, resulting in muscle weakness and eventually paralysis.

Other cases studies have described severe COVID-19 encephalitis (brain inflammation and swelling) and stroke in healthy young people with otherwise mild COVID-19 symptoms.

Larger studies from China and France have also investigated the prevalence of neurological disorders in COVID-19 patients. These studies have shown that 36 percent of patients have neurological symptoms.

Many of these symptoms were mild and include things like headache or dizziness that could be caused by a robust immune response. Other more specific and severe symptoms were also seen and include loss of smell or taste, muscle weakness, stroke, seizure and hallucinations.

These symptoms are seen more often in severe cases, with estimates ranging from 46 percent to 84 percent of severe cases showing neurological symptoms. Changes in consciousness, such as disorientation, inattention and movement disorders, were also seen in severe cases and found to persist after recovery.

SARS-CoV-2, the coronavirus that causes COVID-19, may cause neurological disorders by directly infecting the brain or as a result of the strong activation of the immune system.

Recent studies have found the novel coronavirus in the brains of fatal cases of COVID-19. It has also been suggested that infection of olfactory neurons in the nose may enable the virus to spread from the respiratory tract to the brain.

Cells in the human brain express the ACE2 protein on their surface. ACE2 is a protein involved in blood pressure regulation and is the receptor the virus uses to enter and infect cells. ACE2 is also found on endothelial cells that line blood vessels.

Infection of endothelial cells may allow the virus to pass from the respiratory tract to the blood and then across the blood-brain barrier into the brain. Once in the brain, replication of the virus may cause neurological disorders.

SARS-CoV-2 infection also results in a very strong response by the immune system. This immune response may directly cause neurological disorders in the form of GuillainBarr syndrome. But brain inflammation might also indirectly cause neurological damage, such as through brain swelling. And it's associated with though doesn't necessarily cause neurodegenerative diseases such as Alzheimer's and Parkinson's.

SARS-CoV-2 is not unique in being a respiratory virus that can also infect the brain. Influenza, measles and respiratory syncytial viruses can all infect the brain or central nervous system and cause neurological disease.

Other coronaviruses have also been found to infect the brain and cause neurological disorders.

The related seasonal coronavirus, HCoV-OC43, typically causes very mild respiratory symptoms but can also cause encephalitis in humans. Similarly, the coronavirus that causes MERSand the 2003 SARS virus can cause severe neurological disorders.

Respiratory viruses getting into the brain is thankfully a rare occurrence. But with millions of COVID-19 infections worldwide, there is the risk of significant neurological disease, especially in severe cases.

It is important to be aware of the possibility of neurological manifestations of COVID-19, both during acute illness as well as the possibility of long-term effects. This also highlights the continued importance of preventing viral transmission and identifying those who are, and have been, infected.

Jeremy Rossman, Honorary Senior Lecturer in Virology and President of Research-Aid Networks, University of Kent.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Coronavirus Patients Are Reporting Neurological Symptoms. Here's What You Need to Know - ScienceAlert

Its going to be the era of neuroscience, Roche CEO Bill Anderson declared on stage at the JP Morgan Healthcare Conference in January. The field, he said, had the potential to be in the 20s what oncology was for the last decade.

Five months into that decade, a new biotech is emerging from stealth mode with large investments from Blackstone and two drugs already in Phase II, one of them nearing a pivotal trial. Called Praxis Precision Medicines, since 2016 its raised $100 million with Novo Holdings, Vida Ventures and Eventide also chipping in to back a bet that, by finding the underlying cause of rare neurological diseases, they could find and treat mechanisms behind more common ones.

For all Andersons optimism about the future, though, Praxis emerges at a tough time for neuroscience-focused biotechs. Much of the rest of Big Pharma has all but abandoned the field. The last major piece of neuro-news of the previous decade was the announcement, in December, that Sage Therapeutics vaunted drug for major depressive disorder had failed a large trial, a readout that has since cost the company $6 billion in market cap and induced them to cut more than half their staff. Praxiss lead drug goes after the same indication.

Its a challenging field, Praxis CEO Marcio Souza acknowledged in an interview.

The company began as an effort to findde novomutations that caused epilepsy the spontaneous genetic malfunctions that cause the disease in patients who did not inherit it from their parents. The search turned up, among other things, a gene that affects calcium channels in the brain. But instead of trying to fix that mutation, they used that information to figure out how that channel and how that channel falling out of balance, with neurons firing too much or too little played a role in other diseases.

What became quite clear is that when you were looking beyond just the pure mutations we were all talking about imbalances in a given part of the brain, and normally as it relates to a specific channel, Souza said.A lot of people jumped in the past from mutation correcting that mutation, or correcting the genetic defect. What were doing differently is looking into how that manifests and attempting to correct the actual manifestation.

The result was PRAX-944, a T-type calcium channel blocker that is in the early stages of development for rare forms of genetic epilepsy, but which the company is more aggressively taking forward in essential tremor, one of the more common neurological conditions. They expect to have Phase II proof-of-concept results before the end of the year.

The lead program, though, is PRAX-114, a depression drug. The overlapping indications here are perimenopausal depression, a relatively rare condition compared with major depressive disorder. Despite the vast medical need and market, scientists have struggled for years leading up to Sages flop to build better anti-depressants.

Praxis hopes to have an answer on their drug soon, with plans to enter a pivotal trial before the end of the year. The drug works by allosterically targeting GABAa, the neurotransmitter implicated in a long list of disorders and targeted head-on by benzodiazepines. Souza said the new trial will try to track patients as they would use it in their daily lives, hoping to show what he says they saw in Phase II: a safe and quick drug.

They have the right safety profile, Souza said. Most of the issue is not only with the efficacy, but with the safety of these compounds. And we think 114 has that balance.

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UPDATED: Praxis Precision Medicines launches with $100M and bold sights on long-evasive neurological disorders - Endpoints News

Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

This transcript has been edited for clarity.

Hello. I'm Dr Steven Krieger, a neurologist at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis (MS) at Mount Sinai in New York, reporting for Medscape on the care of MS patients amidst the COVID-19 pandemic.

COVID-19 has impacted every one of us. Of course, we've been counseling our patients to observe stringent precautions: sheltering in place, maintaining effective home quarantine, practicing hand hygiene, wearing masks outside the home per the Centers for Disease Control and Prevention's recommendation, and encouraging social connectedness to prevent isolation during this time of physical distancing. But what else can we do specifically for our patients with MS?

Mount Sinai and many other institutions treating patients with MS have migrated all patient care to virtual and telehealth to try to minimize their exposure to the health system during this time. We're all developing clever ways to perform neurologic exams via video visits and have patients collect and report their own data. If you have any tips on how you're doing this in your own practice, please do add them in the comments section so everyone can benefit from your experience.

Our psychologists have also been holding video support groups for our patients to try to provide remote counseling and address the anxiety that everyone's feeling. We're trying to keep patients with MS from emergency department or urgent care exposure unless it's truly necessary.

In this new setting of COVID-19, we've established a higher threshold for treating MS relapses with steroids. If steroids must be used for a particularly debilitating relapse, we're trying to use oral preparations1250 mg of prednisone a day for 3-5 days with gastrointestinal prophylaxisso that patients can administer them at home and avoid intravenous treatment and nurse visits whenever possible.

There is yet no evidence that MS makes patients more susceptible to this infection. We're all incredibly susceptible to it. There's also no evidence that people with MS have a more severe experience of COVID-19; however, of course, disability is an important comorbidity.

Thankfully, there is also little evidence to date of increased infection susceptibility or risk for patients treated with disease-modifying therapies (DMTs). Whenever possible, our practice has been to not interrupt medication out of concern for COVID-19 and to counsel patients as such. We have to remain vigilant to the risk for disease rebound when DMTs are stopped, particularly the sphingosine 1-phosphate (S1P) modulators or natalizumab.

Sometimes we are choosing to delay infusions to minimize patients' risk of being exposed to the virus at a treatment center. Remember that natalizumab infusions can be safely delayed typically by about 1-2 weeks for extended-interval dosing. For patients with relapsing-remitting MS, we feel that ocrelizumab can probably be safely delayed by perhaps a month or 2 months without real risk for recurrent disease activity. Patients with primary progressive MS on ocrelizumab may be older, with more comorbidities and disability. Therefore, we've typically been trying to delay those infusions until the worst of the COVID-19 crisis, at least in this region, has begun to pass.

Many infusion centers may have limited resources as their nurses and other staff are redeployed for COVID-directed care. As such, trying to decrease the burden on patient centers during this time may be appropriate.

In recent months, we've really fielded two different waves of phone calls and inquiries from our patients with MS. In February and March, we had innumerable calls from people asking what they should do in advance out of concern for this disease. In April, those calls have since changed to ask what they should do now that they have COVID-19. Those are challenging conversations, because COVID-19 affects people in such a heterogeneous way, both in terms of symptoms and severity.

If one of our patients with MS develops COVID-19, we've begun counseling them that they can, for example, hold their interferon injections to avoid additional flu-like symptoms during the acute infection. We could counsel patients to hold S1P modulators like fingolimod during a prolonged episode of high fever, but hopefully not beyond the 14-day period, after which new first-dose observation would be needed again. Again, this strategy aims to prevent an extended amount of exposure in the medical system.

We are recommending that patients hold their infusion therapies at least until a week or so after their primary COVID-19 symptoms and fever have resolved. As previously noted, extended-interval dosing for natalizumab is likely both safe and effective.

And, of course, for any patient with symptoms of COVID-19, it's crucial to counsel them to seek urgent care if they develop difficulty breathing or significant shortness of breath.

There is a very nice review published this April in Neurology by Brownlee and colleagues looking at the implications of using DMTs in people with COVID-19. There's also research looking at the potential for S1P modulators like fingolimod to prevent acute respiratory distress syndrome in aggressively worsening COVID-19. The hope there is that this immunomodulatory strategy might prevent the potentially devastating influx of lymphocytes into the pulmonary compartment.

Clinical data on people with MS contracting COVID-19 are also now being collected by several different research consortia around the world. In pulling together this information, they are hoping to provide crucial information that we can use to guide our treatment decisions.

Comi and colleagues presented data via the National Multiple Sclerosis Society (NMSS), I believe with a publication forthcoming, from three Italian centers at the beginning of this crisis. They looked at 150 patients with MS and COVID-19, 90% of whom remained at home. Only a small handful required intensive care unit admission and critical care. There was no trend for worse outcomes for MS patients on individual DMTs. As with the general population, however, older patients had a more severe course of COVID-19.

The International Women in Multiple Sclerosis group has been gathering the latest data on their website, listing best practices for MS patients in the era of COVID-19. And a joint effort from the NMSS and the Consortium of Multiple Sclerosis Centers, called COViMS (COVID-19 Infections in MS & Related Diseases), is going to aggregate data for MS patients with COVID that we can all learn something from in the weeks and months to come.

As we await these forthcoming data and continue to provide care for patients with neurologic disease and with MS in particular, I'd like to offer a little reminder of the two essential tools we have at our disposal: effective hand hygiene and masks to prevent transmission of this disease. We need to protect ourselves as we protect our patients. Stay safe, everyone.

Reporting from New York City for Medscape, I'm Steven Krieger.

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What We Know About Multiple Sclerosis and COVID-19 - Medscape

As doctors gain a better understanding of how the coronavirus attacks the human body, the list of possible symptoms caused by an infection continues to grow. Itnow appears to include neurological damage.

Reportsfrom China, where the pandemic originated, and other coronavirus hotspots, including the United States, suggest that the coronavirus can spread to the brain, potentially leading to a seizure, stroke or encephalitis.

In response,theU.S. Centers for Disease Control and Preventionhas added "new confusion or inability to arouse" to the list of emergency warning signs for COVID-19.

The most common symptoms are cough, fever, fatigue and difficulty breathing. OtherCOVID-19 patients have experienced headache, vomiting, nausea and loss of sense of smell and taste.

But there is growing concern about the coronavirus's ability to harm the brain.

According to Dr. Lin Mei, director of the Cleveland and Brain Health Initiative, the coronavirus can travel to the brain from the nasal cavity, through the bloodstream or by attaching itself to nerve terminals.

More research is needed to determine whether the coronavirus directly causes neurological symptoms by breaching the blood-brain barrier or if those symptoms are a side effect of the virus attacking other systems in the body.

For instance, does the coronavirusdirectly cause a stroke or does the infection lead to a spike in blood pressure, which then triggers a stroke?

Henry Ford Health System doctors recently reported a case of encephalitis in a 58-year-old Detroit woman who tested positive for COVID-19. She developed acute necrotizing encephalitis, a central nervous system infection more commonly seen in young children.

Her symptoms began with just a fever, cough and muscle aches. But a few days later, she started experiencing confusion and disorientation. She was rushed to the emergency department by ambulance and was tested for the flu and COVID-19. The flu test came back negative, the rapid COVID-19 test positive.

Her care team suspected she had encephalitis and ordered imaging scans. The MRI scan showed abnormal lesions inboth the thalami and temporal lobes of the brain, which regulate consciousness, sensation and memory function.

"This is significant for all providers to be aware of and looking out for in patients who present with an altered level of consciousness,"Dr. Elissa Fory, a Henry Ford neurologist saidin a statement."We need to be thinking of how we're going to incorporate patients with severe neurological disease into our treatment paradigm.This complication is as devastating as severe lung disease."

Frank Carter, a 82-year-old man in Tennessee, also experienced neurological symptoms related to COVID-19, NBC Newsreported. Besides some nausea and vomiting, the first indicator of the infection was delirium, according to his daughter, who is a nurse. He died within a week.

There have been neurological symptoms in COVID-19 patients in China as well.

At the Union Hospital of Huazhong University of Science and Technology in Wuhan, 36.4% of COVID-19 patients developed neurological issues,according to a study published in the journalJAMA Neurology.For some, the neurological symptoms even showed up before the cough and fever.

"We've been telling people that the major complications of this new disease are pulmonary, but it appears there are a fair number of neurological complications that patients and their physicians should be aware of," Dr. Andrew Josephson, editor of JAMA Neurology, wrote in a commentary to the study.

Dr. E. Wesley Ely, a professor of medicine and critical care at Vanderbilt University Medical Center is collaborating with the Critical Illness, Brain Dysfunction and Survivorship Center in studying post-mortem brain tissue to better understand how COVID-19 affects the neurological system.

The researchers will measure different regions of the brain to see whether they have shrunk. They also will look for damage to neurons and evidence of the proteins associated with dementia and Alzheimer's disease. Carter's brain was the first to be donated to the project.

Health officials say that it is important for people to watch for sudden cognitive changes in family members so they can more quickly get the help they might need.

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COVID-19 may harm both the brain and the lungs - PhillyVoice.com

SOUTH SAN FRANCISCO, Calif., April 28, 2020 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (STSA), a clinical-stage biopharmaceutical company, announced today that it will host a Key Opinion Leader (KOL) event discussing STS101 and the acute treatment of migraine on Tuesday, May 5, 2020 at 12:00pm Eastern Time.

The event will feature presentations by headache medicine specialists Jessica Ailani, MD, from MedStar Georgetown Headache Center, and Alan Rapoport, MD, from The David Geffen School of Medicine at UCLA, addressing the current treatment landscape for the acute treatment of migraine, unmet needs, and potential roles for Satsumas product candidate, STS101. As well, Satsuma's Chief Medical Officer, Detlef Albrecht, MD, will review the design of the ongoing STS101 EMERGE Phase 3 pivotal efficacy and safety trial. Following presentations, Drs. Ailani, Rapoport, Albrecht and members of Satsumas management team will be available to answer questions from the audience.

STS101 is an investigational product designed to make the well-established anti-migraine benefits of dihydroergotamine (DHE) more broadly accessible to people with migraine. STS101 is a simple-to-use, nasal-route DHE product featuring easy and quick self-administration (within a matter of seconds) and a pharmacokinetic profile similar to DHE administered by intramuscular injection, which Satsuma believes is necessary for achieving optimal DHE efficacy. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, pre-filled and ready-to-administer non-injectable DHE product candidate that it believes could, if approved, better meet the needs of people with migraine than current and development-stage DHE products. STS101 has undergone extensive preclinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Jessica Ailani, MD, is a Professor of Clinical Neurology and Director of the MedStar Georgetown Headache Center at MedStar Georgetown University Hospital in Washington, DC. She received her medical degree from the Stony Brook University School of Medicine in New York, followed by an internship at Winthrop University Hospital in Mineola, New York. Dr. Ailani subsequently completed a residency and Chief Residency in Neurology at NYU Langone Medical Center in New York, New York, followed by a fellowship in Headache Medicine at Thomas Jefferson University in Philadelphia, Pennsylvania. She is board-certified in Neurology with subspecialty certification in Headache Medicine.

Dr. Ailani is a fellow of the American headache society and of the American Academy of Neurology. She holds a position on the board of the American Headache Society as a member at large. For AHS, Dr. Ailani is a co-chair of the Practice management committee and is on the scientific and Scottsdale program planning committees. Dr. Ailani is Section Editor of Unusual Headache Syndromes for Current Pain and Headache Reports and a reviewer for several professional journals. Dr. Ailani has presented nationally on topics surrounding headache medicine.

Alan Rapoport, MD is a Clinical Professor of Neurology at The David Geffen School of Medicine at UCLA, Los Angeles, California, where he teaches medical students, neurology residents and fellows. He is a Past President of the International Headache Society (IHS) and the founder and Director-Emeritus of The New England Center for Headache, in Stamford, Connecticut. Board-certified in Neurology and Headache Medicine, he has co-authored more than 300 articles,10 books, as well as multiple chapters and posters on headache and other neurological diseases.

Dr. Rapoport is the Co-Founder and CEO of BonTriage, an IT company in Silicon Valley, California, dedicated to helping patients and doctors around the globe by collecting detailed patient histories on line and linking with an app that monitors patient progress and outcomes. Dr. Rapoport has served on the Board of Directors of the American Headache Society (AHS) and is the immediate past President of the Fairfield County Neurological Society (Connecticut), the Founding President of the Headache Cooperative of New England (HCNE), the Founding Director of the Headache Cooperative of the Pacific (HCOP). He is the director of the headache day at the annual Controversies in Neurology (CONy) which was held in Madrid in 2019 and will be held in London in October 2020.

Story continues

About Satsuma Pharmaceuticals and STS101Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit http://www.satsumarx.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the Company), as well as the Companys plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as aim, anticipate, assume, believe, contemplate, continue, could, due, estimate, expect, goal, intend, may, objective, plan, predict, potential, positioned, seek, should, target, will, would, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Companys expectations regarding the potential safety and efficacy of STS101; the potential benefits of STS101, if approved; and the likelihood of regulatory filings and approvals for STS101. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Companys actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Companys Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Companys ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; the risk that the COVID-19 worldwide pandemic may negatively impact the development of STS101; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Companys ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:

Corey Davis, PhDLifeSci Advisors, LLCcdavis@lifesciadvisors.com

Tom ONeil, Chief Financial OfficerSatsuma Pharmaceuticals, Inc.tom@satsumarx.com

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Satsuma Pharmaceuticals to Host Key Opinion Leader Event: STS101 and the Acute Treatment of Migraine - Yahoo Finance

Certifications

Board Certified: Cardiovascular Disease

Cardiovascular Disease, Interventional Cardiology

Doylestown Health Physicians

Medical School: Georgetown University School of Medicine

Residency: University of Massachusetts Hospital

Fellowship: Cardiovascular Disease, Cleveland Clinic Foundation; Interventional Cardiology, Presbyterian Medical Center

Male

English

Joseph McGarvey, MD, has been recognized by Philadelphia Magazine as a Top Doc for 2018-2019.

Dr. McGarvey is an Interventional Cardiologist specializing in emergent stenting for acute heart attacks. His areas of expertise include treatment of peripheral vascular disease (PVD), cardiac catheterization, carotid stenting, intra-arterial thrombectomy (IAT) treatment for acute stroke, ventricular device implantation, and AAA stent grafting for abdominal aortic aneurysms, as well as coronary stenting for acute heart attacks.

Dr. McGarvey is active in the treatment of structural heart disease and the implantation of the Watchman device for AFib patients that has the added benefit to patients who cannot tolerate blood thinners. He performs Patent Foramen Ovale (PFO) closures for patients with strokes and a hole in their heart. He joined the practice in 1996 and currently runs an active clinical research program.

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Joseph F. McGarvey Jr., MD, FACC | Interventional ...

The main symptoms of COVID-19 were known as coughing, shortness of breath, and fever. But recently, more and more it becomes known about new other symptoms of coronavirus infection.

According to Dr. Daniel Griffin, a physician-scientist board certified in Infectious Disease, the phenomenon of paresthesia can be a sign of coronavirus infection.

As the New York Post noted, this disorder is well known to people suffering from diabetes and some autoimmune diseases. However, some patients with COVID-19 complained of the same symptoms (feelings of burns, pricks from needles, light electric shocks on the skin).

The antibodies that the body uses to protect against COVID-19 infection can disrupt the nervous system, causing unusual, not very pleasant, sensations, he noted.

Coronavirus infection can have other neurological symptoms, including tingling or numbness in the arms and legs, according to Harvard Health.

Experts name the following neurological disorders, which may be symptoms of a coronavirus infection:

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Skin tingling, neurological disorders: New unexpected COVID-19 symptoms revealed - Information-Analytic Agency NEWS.am

By Orly Avitzur April 16, 2020

A neurologist with the CDC discusses what's known to date about COVID-19 and what neurologists should be especially alert to.

On March 19, Neurology Today caught up with AAN member, James J. Sejvar, MD, a neurologist and epidemiologist at the US Centers for Disease Control and Prevention (CDC), who has been working on COVID-19 since early January when the first reports of illness were announced in China. In 2009, Dr. Sejvar he asked the AAN to collaborate with the CDC in reporting cases of Guillain-Barr syndrome (GBS), and any adverse events that were suspected of being associated with vaccines in general or the 2009-H1N1 vaccine.

Over the past eleven years, Dr. Sejvar has been deployed to regions of the United States to track the West Nile virus outbreak (2012), to remote villages in central Africa to investigate the Ebola outbreak (2014), to South America to track the Zika pandemic (2016), among numerous other urgent infectious disease epidemics.

I have worked with a number of worrisome viral outbreaks over the years, but none have frightened me as much as COVID-19 from the standpoint of spread of the disease, apparent ease of transmission, and associated morbidity and mortality, Dr. Sejvar told Neurology Today.

We reached Dr. Sejvar, who has been working 19-hour days, after his return from an extended trip to Rhode Island to engage in a special study examining the risk of contracting the 2019 novel coronavirus after exposure. Back in Atlanta on a mandated 14-day quarantine, he shared his current knowledge and advice on COVID-19.

We are continuously understanding more and more but there is still a lot we do not know: First, how long is someone contagious, and second, how easy it is to spread. We do know that people of older age and those with underlying conditions are at highest risk. People who have impairments that cause difficulty in clearing secretions such as those with Parkinson's disease, severe multiple sclerosis, GBS, or other chronic neuropathies are among those at higher risk. We are also concerned about people with seizure disorders. Although there is nothing specific about their condition that places them at risk, we know that seizures can be triggered in the setting of a febrile illness.

People with those conditions or of older age groups, as well as those taking immunosuppressants or immune-modulating medications, should adhere to the CDC guidelines and HHS advisories to minimize contact with others, both asymptomatic individuals and those who are symptomatic. They need to take these messages to heart.

While most neurologists are not currently on the front lines of directly working with COVID-19, they are clearly seeing people with neurologic diseases associated with aging, such as Alzheimer's disease and Parkinson's disease. Clinicians need to be fastidious in terms of infection control and whenever possible, place symptomatic patients in face masks and make sure that contact is limited. If a patient has known respiratory symptoms, neurologists should try to use full protective personal equipment (PPE) before examination to minimize exposure.

Admittedly, we are in the midst of a very difficult situation in terms of PPE. Quite frankly, there are health departments without adequate PPE. If possible, limit the exposure of someone with respiratory illness or signs of COVID-19 and keep them isolated. The government has worked with industry to ramp up the manufacturing of N95 masks, surgical masks, gowns, and eye shields. In lieu of masks, some people are using bandanas on both the physician and the patient to try to minimize the transmission of respiratory droplets. We know this is not ideal, but the CDC says that it's better than nothing.

In Rhode Island, we have set up tents that cars can go through and people can get swabbed after a brief history of present illness and past medical history is attained. The provider is outside the car and the patient is inside the car. This is being replicated in Massachusetts, New York, and other places. It's possible that a neurologist may be able to test someone and get an accurate assessment while minimizing exposure in waiting rooms and reception areas, by setting up systems that minimize patient contact.

There is a serologic test that the CDC developed for people who had been infected. In January, a group of students from a school in Rhode Island visited Italy, France and Germany before returning home. A teacher came down with COVID-19 and the students were all exposed. We are now conducting a sero-survey to look at how many kids exposed are sero-positive. The serology test is not yet Clinical Laboratory Improvement Amendments (CLIA)-approved and it still needs to be validated with positive- and negative-predictive value. We also don't know whether mounting an antibody response in IgG and IgM confers protection as it does with other viruses. As this is a new virus, we cannot assume that getting ill and recovering provides absolute protection.

One of the most alarming concerns is that COVID-19 transmission in the hospital is orders of magnitude higher than in the community. My biggest fear is that we incur a situation in which we end up with a limited availability of ventilators for people who are elderly or have underlying medical conditions. While the overall fatality rate is about 0.8-1 percent, recent age-stratified data suggests a rate of 9.5 percent for those over the age of 70 years. I am also very worried about the attitude of some young people we are seeing on the news who are ignoring warnings, congregating on beaches and in bars on spring break. Although there are fewer cases, we are definitely seeing people under the age of 45 with pneumonia.

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COVID-19: Advice from CDC Neurovirologist and... : Neurology Today - LWW Journals

Article In Brief

In response to COVID-19, many academic and private-practice neurologists have turned to telemedicine. They discuss what works and what has been challenging.

Neurologists in academic and private practice alike are scrambling to embrace telemedicine as one part of their response to the COVID-19 pandemic.

While heartened by the Trump administration's announcement on March 17 that it is lifting many telemedicine restrictions, both on reimbursement and HIPAA compliance, neurologists nevertheless expressed anxiety and some confusion over how to handle the new realityand how long it will last.

We're trying to figure out how to avoid the chaos, stay on solid ground, and feel comfortable knowing everything will be all right eventually, said Brad C. Klein, MD, FAAN, a headache specialist at Abington Neurological Associates in Pennsylvania.

In private practice with nine fellow neurologists and privileges at nearby Abington Hospital, Dr. Klein said his group held an urgent meeting on the evening of March 15 to develop a response to the fast-evolving situation.

Even at a major academic neurology center with an established telemedicine program, efforts to protect physicians, staff, and patients are daunting.

We are feeling our way, said Neil A. Busis, MD, FAAN, who arrived on March 1 at New York University Langone Health to lead its telemedicine program for the department of neurology. Things are moving rapidly. NYU already has had a very robust virtual health program. Neurology has some pilot programs; it's my charge to develop a broader range of options. As you can imagine, right now we're overwhelmed.

Even so, telemedicine evangelists who have been preaching the benefits of digital communication for years say that neurologists will like the new normal, once they get used to it.

I see almost all my patients over the internet, said Ray Dorsey, MD, MBA, the David M. Levy professor of neurology and director of the Center for Health Technology at the University of Rochester Medical Center in Rochester, NY.

I haven't set foot in the clinic in six years. In general we shouldn't make patients come to the clinicians; we should bring care to them. Why do we ask people with compromised driving ability and mobility to come to us? It's crazy. You will learn a whole lot more about your patients and form a deeper relationship with them.

For those not already running a telemedicine program, however, the challenges of building a program on the fly, in the face of a pandemic, are not trivial. But experts hope that an announcement by the White House would ease some restrictions.

In a White House press briefing on March 17, President Donald J. Trump announced that Medicare patients can now visit any doctor by phone or videoconference at no additional cost, including with commonly used services like Facetime and Skype.

No longer will telemedicine benefits be restricted to Medicare patients in rural areas without access to physicians nearby.

Seema Verma, administrator of the Centers for Medicare and Medicaid Services (CMS), said at the news conference: Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home. And these services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.

Alex Azar, Secretary of Health and Human Services, issued a press release stating that the administration will essentially stop enforcing elements of HIPAA that required physicians to use only secure telecommunication services when communicating with patients. For the time being, at any rate, physicians can use (and bill Medicare for) ordinary telephone and video links such as Skype and Zoom.

States are also taking action to speed access to medical care in the era of social distancing. On March 14, both New York Governor Andrew M. Cuomo and Colorado Governor Jared Polis announced that insurance companies in their states must waive co-pays for telehealth visits. The next day, Massachusetts Governor Charlie Baker announced emergency actions to address COVID-19, including ordering all commercial insurers...to cover medically necessary telehealth services in the same manner they cover in-person services.

The moves come as patients around the nation are overwhelming telemedicine services, producing technical and procedural backlogs, Stat News reported.

In response to the changes in how telemedicine visits are being coded and reimbursed, the AAN has established a small working group of experts to develop a new guidance document for members, according to Luana Ciccarelli, the Academy's senior manager of reimbursement & coding.

In place for more than 10 years, the Mayo Clinic Connected Care platform is taking on the recent uptick in telemedicine sessions relatively smoothly, according to Bart Demaerschalk, MD, FAAN, professor of neurology at Mayo Clinic's Phoenix campus and director of its telestroke program.

To the degree possible, neurologists and neurology allied health staff are now working from home, said Dr. Demaerschalk. Clinic appointments are being rescheduled whenever feasible to a telemedicine format. We are trying to utilize a wide variety of digital health tools to best serve and protect our patients including portal messages, telephone, eConsults, video telemedicine, and remote patient monitoring. Our acute-care neurology services, including stroke, can use robotic telepresence devices, allowing neurologists to participate in acute-care patient encounters from their home or office.

The robotic devices, he explained, are remotely drivenoften autonomouslyand include auto navigation and obstacle-avoidance capabilities. In addition to offering synchronous audio-video links, they usually employ such peripherals as stethoscopes, otoscopes, and ophthalmoscopes that a neurologist can deploy remotely. Even so, the availability of telemedicine services does not preclude in-person neurology care, Dr. Demaerschalk said.

I've been in the emergency department several times today to treat an acute stroke syndrome, a seizure, and a patient with a brain tumor, he said. We are abiding by the Centers for Disease Control and Prevention [CDC] recommendations. When a patient presents with a neurologic complaint and has passed all the screening evaluations, we follow standard universal precautionsnothing elevated. No routine use of gloves or masks. Mostly we are seeking to reduce the number of people in a given area and the theoretical risk of viral spread from those patients who might be asymptomatic.

In keeping with CDC recommendations, he said, a few staff members, including at least one neurologist, are currently self-quarantined at their homes after returning from domestic or international travel to areas with high numbers of COVID-19 cases.

At the Cleveland Clinic's Mellen Center for Multiple Sclerosis, staff neurologist and medical director Robert J. Fox, MD, FAAN, said they are taking their response to the outbreak in stride.

First and foremost we are encouraging patients to use online visits as much as possible, said Dr. Fox. We are also offering some clinicians at high risk for COVID-19 complications the opportunity to work from home if possible. About three-quarters of our follow-up visits are now being conducted online, which makes working from home possible.

While preparing for the possibility that neurologists who normally practice in the outpatient clinic will be pulled over to the inpatient service if hospitalizations rise due to COVID-19, relatively modest precautions are being taken for now. As at Mayo, the outpatient neurologists are not generally wearing gloves or masks, he said.

But, he said, I haven't shaken hands with a patient in over a week, which is very unnatural for me. We're waving, we're doing virtual high fives, and we're washing our hands a lot.

After developing a telemedicine program at the University of Pittsburgh Medical Center, where he was clinical professor of neurology, Dr. Busis had the misfortune to arrive at NYU Langone at the beginning of March with an ordinary cold.

The last thing I wanted to do on my first day on the job was to flip out patients and be seen as the COVID-19 equivalent of Typhoid Mary, Dr. Busis said. So he did what he recommends patients do: He arranged a virtual care appointment. After signing up for the NYU Langone service, he filled out an online questionnaire and then queued up in the virtual waiting room.

When the provider showed up, I saw her on a split screen on my iPhone, Dr. Busis said. She could see me, and I could see her. After talking, she told me, You have a cold. Wear a mask, wash your hands a lot, and be upfront with your patients. That's what I did. When I saw my first patients, I told them, Don't worry, this is just out of an abundance of caution. My patients accepted it fine.

Now digging into his job of ramping up the medical center's telemedicine program, not only in neurology but systemwide, Dr. Busis said the easiest part is the telemedicine visit.

Setting up the audio and video at both ends is actually fairly easy, he said. The harder part is documentation, coding, billing, how you notify people, and how you integrate the virtual visits into your workflow. You can't just do telemedicine at the end of the day; you need a schedule combining in-person and virtual visits. And of course you still have to figure out some sort of way to get reimbursed for services, especially if this is going to become sustainable over the long-term.

Until the changes announced by President Trump and other officials on March 17, coding for telemedicine visits was tricky, Dr. Busis said. Different insurers used different codes, and CMS had its own set of codes. Now, he said, The reimbursement landscape is rapidly changing and many of the old restrictions are no longer in effect, at least temporarily. This is a welcome development. All of us wonder how long these restrictions will remain lifted and if they will ever be reinstated.

While Dr. Dorsey at the University of Rochester Medical Center has worked in telemedicine for years, the sudden transition to virtual care for other neurologists there has been bumpy.

The move to telephone and video telemedicine work has been a major change for some of our providers, particularly some that are not as tech-savvy, said Adam G. Kelly, MD, FAAN, associate professor of neurology and director of the New York State Primary Stroke Center at Highland Hospital. It's been a big paradigm shift for our clinic staff but they have done an awesome job modifying what they do in a very short time. This was an almost overnight switch on our institution's part.

With waiting rooms extraordinarily quiet because of the shift to telemedicine, Dr. Kelly said some neurologists there have had to self-quarantine after attending a medical conference where they were potentially exposed to the virus.

Fortunately no one has developed symptoms yet, he said. But, he added, We have had scheduling challenges related to the self-quarantining. We have also needed to build in multiple layers of back-up coverage in case providers become ill. We have asked some providers to minimize contact with one another to decrease the odds that a large group will all need to quarantine should one become ill.

Without the infrastructure and experience of a large institution to rely on, neurologists in private practice are facing what some fear could be an existential challenge.

We had one of our telephone operators today tell our office manager that her son is a nurse who might have been exposed to someone with COVID-19, Dr. Klein said. The administrator had to tell her: You're banned, you're not coming back into the office for 14 days.

Unlike academic telemedicine programs that merely need to ramp up to meet the current need for virtual visits, Dr. Klein's practice is facing the prospect of having to transition virtually overnight.

We only last week started a process to understand the nuances of getting telemedicine into our office, he said. We're trying to understand the reimbursement rules, who pays for it, what we do if the insurers don't cover it. We need to find the right vendor and get it up and running.

Politics aside, he and other neurologists said, greater leadership from the federal government, as well as from insurers, would be helpful.

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Neurologists Scramble to Respond to COVID-19 with... : Neurology Today - LWW Journals

(Photo : Photo by Robina Weermeijer on Unsplash)

Nicole Hutcherson, daughter of the late Frank M. Carter, who died from COVID-19 a week ago, recounts how her father's symptoms of the disease were not the common ones seen in most people.

Frank Carter, an 82-year-old local of Goodlettsville, Tennessee asserted he was fine despite having nausea and vomiting. Hutcherson said her father thought he was just dehydrated. Being a nurse, she had some supplies ready on hand and attempted to insert an IV line on her father to address his dehydration.

She recalls how her father had no reaction when she inserted the needle in his arm as if he was sedated. This was when Hutcherson noticed something was off with her father's mental state. She thought it was unusual, as her father had shown no prior signs of dementia or any other cognitive diseases in the past.

Hutcherson believes that the delirium she recognized in her father was one of the first signs of his infection of the coronavirus. Carter died within a week of experiencing symptoms.

Also Read: A Quicker Solution to Coronavirus May Be Vaccines That Are 50% Effective, Scientists Claim

There is growing evidence to suggest that COVID-19, can affect not only the lungs but the brain, as well.

Dr. E. Wesley Ely, a professor of medicine and critical care at Vanderbilt University Medical Center, speculates the possibility of coronavirus being capable of invading the brain. Not much is certain about the coronavirus and its connection with the neurological system.

Due to the lack of information about the matter, Ely and colleagues with the Critical Illness, Brain Dysfunction, and Survivorship Center, in partnership with Vanderbilt and the Nashville VA, have launched a study of post-mortem brain tissue to study signs of COVID-19 in the brain.

Funding for the research will be the National Institutes of Health. The team plans to analyze the brains' neurons for damage, measure different brain regions to see if parts have unusually shrunk, and examine the hippocampus, which plays a large role in memory. The first brain donated to the project was Frank M. Carter's.

A recent study of 214 patients in Wuhan, China, found more than 33% had neurologic manifestations of the disease, including stroke and loss of consciousness. Doctors in the United States have noted the same.

Dr. Johanna Fifi, the associate director of the cerebrovascular center at the Mount Sinai Health System in New York, told NBC News that she had five COVID-19 patients under the age of 49, all with strokes resulting from a blockage in one of the major blood vessels which led to the brain.

Two of her patients had what Fifi described as mild coronavirus infections before the stroke. The other three displayed no symptoms at all.

A similar case is that of 40-year-old Jesse Vanderhoof, a nurse with coronavirus, who spent more than a week on a mechanical ventilator in an intensive care unit in a hospital in Idaho. His wife, Emily Vanderhoof, described how her husband's mind 'wasn't right' as he yanked his IV out of his arm and talked in circles about random topics.

Read Also: Tech Company Claims UV LED Could Kill Coronavirus in 30 Seconds in Support to Research by UC Santa Barbara

Excerpt from:
Coronavirus Patients First Symptom was Delirium; Neurologists Form Theory that Virus Could Invade the Brain - Science Times

Patients with COVID-19 have suffered strokes and other neurological symptoms, according to the first scientific study to analyse the effects of the disease on the brain.

The study found that neurological effects were seen in just over a third of all cases of hospitalised COVID-19 patients, but affected more than 45% of those with severe infections.

It isn't yet clear if the coronavirus is causing the strokes directly or as a result of the body's inflammatory response, and leading neurologists say more research is needed.

They warn that as well as respiratory symptoms, doctors need to consider potential neurological effects when assessing new patients.

The study was carried out by researchers at Huazhong University in Wuhan, and the Barrow Neurological Institute in Arizona.

The team analysed cases in Wuhan in China, the original epicentre of the outbreak, between 16 January and 19 February - including 214 hospitalised patients whose diagnoses were laboratory-confirmed.

Just over a third of these patients, 78 (36.4%), had neurological symptoms as well as respiratory symptoms.

"Compared with patients with non-severe infection, patients with severe infection were older, had more underlying disorders, especially hypertension, and showed fewer typical symptoms of COVID-19, such as fever and cough," they found.

The study, in the journal JAMA, was published alongside an editorial by leading neurologists which notes the similarity of the coronavirus to SARS - which researchers have shown caused strokes.

However, unlike in SARS patients, the new study found that neurological symptoms could occur very early within the infection.

Some patients presented at hospital without a fever but had neurological issues including losing their taste or smell, as well more significant impacts such as impaired consciousness, headaches and dizziness.

The scientists warn that the disease may infect the "nervous system and skeletal muscle as well as [the] respiratory tract" which could provide healthcare workers with an additional way to diagnose patients.

COVID-19 has "now reached pandemic status and is common all over the world" said the neurologists in their editorial.

"With so many affected patients, we can expect as neurologists to be confronted with these patients commonly in coming months and years."

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Coronavirus: Patients have suffered strokes and other neurological symptoms, says study - Sky News

The damaging effects of covid-19 will extend beyond the lungs to our brains and minds, scientists are warning. The viral disease may directly affect the nervous systems of some patients both during and post-infection, and the stress of the pandemic and its economic fallout is likely already leading to spikes in anxiety among the general public.

In a new preprint paper released this week in the journal Brain, Behavior and Immunity, researchers Emily Troyer, Jordan Kohn, and Suzi Hong, all from the University of California San Diego, argue that the world is set to face a crashing wave of neurological and psychological illness caused by covid-19.

Some of these harms can be attributed to the obvious changes that the pandemic has made to our daily lives, even for people not sickened by the coronavirus that causes covid-19. But theres a growing sense among doctors and scientists that the virus itself can directly affect our brain health.

I think we have all recently witnessed a significant shift in our society and economy, which has been associated with distress and fear for everyone, lead author Troyer, a psychiatrist at UCSD, told Gizmodo. We dont want to minimize that, but my colleagues and I were also curious about whether or not individuals who developed covid-19 would experience not only the psychological stress associated with a pandemic, but also other neuropsychiatric symptoms related to the effects of the virus or host immune response on the nervous system.

Past pandemics caused by viral respiratory illnesses such as the flu, Troyer and her co-authors noted, have been closely linked to reported spikes of neurological or psychiatric symptoms such as brain damage, mood changes, or muscular dysfunction. In many cases, these symptoms have happened during someones initial infection; other times, they happen post-infection. And were starting to see the same pattern with covid-19 emerge. Rarely, confirmed covid-19 patients have also had brain swelling, strokes, or seizures, while many more patients have reported a loss of smell or taste, which can be caused by neurological damage.

The authors lay out a few theories for how this is happening. Some evidence has suggested, for instance, that the coronavirus can slip past the blood-brain barrier and infect nerve cells directly. Another theory is that the immune system overshoots its response to the virus, causing systemic damage throughout the body, including to the brain. They also theorize that certain immune cells can become infected, migrate to the brain, and then trigger dangerous inflammation. Another less supported but plausible theory is that the coronavirus damages the gut microbiome, which then affects the brain.

All these explanations could be true to some extent. But even making it through the initial infection relatively healthy may not spare you from neurological problems down the line. Some viral infections, including the flu, are rarely known to trigger later autoimmune disorders that affect the brain and nervous system, which can cause muscle weakness, chronic pain, and even paralysis.

Beyond those concerns, the pandemic is also affecting peoples mental health. Millions have seen covid-19 sicken or kill their family and friends, with many unable to be with their loved ones as they died or attend funerals in person, due to the aggressive measures needed to slow down person-to-person transmission. These same measures have shut down or curtailed non-essential businesses, dramatically changing most peoples daily lives and devastating many financially. In countries like the U.S., with weak worker protections, these lockdowns have led to the highest unemployment rates seen since the Great Depression.

Already, the authors note in their paper, there have been some reports of suicides among people worried about having the illness or catching it. Essential workers, including in health care, are also reporting high levels of stress and burnout related to covid-19, as many struggle with meager pay and risky working conditions that leave them exposed to the virus.

This pandemic is a potential source of direct and vicarious traumatization for everyone, the authors wrote.

Because were still in the early stages of this pandemic, it may take a long time before we can know how commonly these neurological afflictions are happening among covid-19 patients, especially those post-infection. One unanswered question is whether these complications happen more in people infected with the novel coronavirus, called SARS-CoV-2, than they do in people with other cold and flu viruses. But compared to other recent outbreaks of deadly coronaviruses like SARS and MERS, the scale of this coronavirus pandemic is significantly greater, Troyer said.

By raising awareness of these problems now, the authors hope that the medical community keeps a close eye on the brain health of covid-19 patients moving forward.

We also want people to be aware that the nervous system could be involved in COVID-19, so we hope people will talk to their physicians about any emotional, behavioral, cognitive, or sensorimotor symptoms they might have over the course of their recovery, Troyer said. We dont want to cause people more worrywe just want people to know to talk to their healthcare providers about these kinds of symptoms if they arise, and together we will get through this.

If you or someone you know is having a crisis, please call the National Suicide Prevention Lifeline at 800-273-8255 or text the Crisis Text Line at 741-741.

Excerpt from:
Researchers Warn of 'Wave' of Neurological Illness Caused by the Coronavirus - Gizmodo

A study out of China finds that strokes, altered consciousness and other neurological issues are relatively common in more serious cases of Covid-19.

Looking at 214 cases of severe coronavirus illness treated in Wuhan city during the early phase of the global pandemic, doctors reported that 36.4% of patients displayed neurological symptoms.

Sometimes these symptoms appeared in the relative absence of "typical" symptoms of Covid-19 fever, cough, diarrhoea the team said.

In such cases, doctors should consider coronavirus infection as a potential cause of the problem "to avoid delayed diagnosis or misdiagnosis", said a team led by Dr Bo Hu, a neurologist at Union Hospital in Wuhan.

Hu's team published their findings online in JAMA Neurology.

Absence of typical symptoms

The suspicion that the novel coronavirus could infiltrate and affect the brain and central nervous system is not new. Last month, numerous reports emerged that one key sign of infection was a loss of sense of smell, pointing to the virus somehow affecting nerve pathways.

In the new report, Hu's team tracked outcomes for more than 200 people treated at three hospitals in Wuhan, the original epicenter of the Covid-19 pandemic. Patients all had disease severe enough to warrant hospitalisation, and were treated between 16 January and 19 February. They averaged about 53 years of age.

Looking specifically at symptoms affecting the brain or central nervous system, the team found that these issues became more common as the severity of illness rose. And, in some cases, typical Covid-19 symptoms were absent.

"Some patients without typical symptoms of Covid-19 came to the hospital with only neurological manifestation as their presenting symptoms," the researchers wrote. In some cases, these issues could be life-threatening: there were at least six cases of stroke or brain haemorrhage observed among those studied, Hu's group reported.

Whether or not infection with the coronavirus directly triggered strokes is unclear, the team said, but in severe Covid-19, a "rapid clinical deterioration or worsening could be associated with a neurologic event such as stroke, which would contribute to its high mortality rate."

Other neurological issues were also at play. Many patients arrived at the hospital disoriented or confused, or were dizzy or had headaches or even seizures, the Chinese group said. Impairments in taste or smell were also seen.

More specific neuroimaging needed

Older patients, many of whom had other underlying chronic illnesses, were at highest risk for neurological issues tied to Covid-19, the study found.

Dr Rafael Ortiz is chief of neuro-endovascular surgery at Northwell Health Western Region in New York City and Westchester, New York.

Reading over the new report, he said "these findings could be related to direct involvement of the virus in the brain, brainstem and peripheral nerves." Other symptoms may be due to the stresses put on the body by the illness itself, he added.

The Chinese researchers and Ortiz agreed that this early study may not be the last word on how the new coronavirus affects the brain.

"A prospective, observational study with a larger number of patients that includes more specific neuroimaging and other diagnostic tests is warranted for more conclusive evidence," Ortiz said.

READ | Neurological ailments in some coronavirus patients - what could this mean?

READ | How scientists found the fingerprint behind South Africa's Covid-19 virus

READ | A lack of sleep affects your immune system - here's how quality sleep can help you fight the coronavirus

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Brain, nervous system affected in 1 in 3 cases of severe Covid-19 - Health24

NEW YORK, April 15, 2020 /PRNewswire/ --

The global rare neurological disease treatment market is expected to reach US$13,830.96 million by 2027 from US$ 7,300.12 million in 2019. The market is estimated to grow at a CAGR of 8.5% from 2020 to 2027.

Read the full report: https://www.reportlinker.com/p05882129/?utm_source=PRN

Driving factors of the rare neurological disease treatment market are growing prevalence of rare neurological diseases and favorable pipeline drugs and robust research activities for the treatment of rare neurological diseases. However, high treatment cost incurred is likely to show negative impact on market growth during the forecast period.Rapid developments in healthcare and drug discovery are leading to the introduction of new therapeutic solutions for the treatment of rare neurological diseases.Authorities such as World Health Organization, National Institute of Neurological Disorders and Stroke, and National Institutes of Health are taking constructive steps to encourage research activities to find a remedy for rare neurological diseases.

For instance, in August 2019, National Institute of Neurological Disorders and Stroke and National Center for Advancing Translational Sciences invited researchers to conduct study on rare neurological and neuromuscular diseases.In order to cope up with rising prevalence of rare neurological diseases and geriatric population, pharmaceutical companies are actively participating in the development of drugs.For instance, in December 2019, Healx in partnership with Boehringer Ingelheim announced a plan to discover new treatment approaches in the coming years.Additionally, they are planning to discover new therapeutic options for the treatment of fragile X syndrome and Pitt-Hopkins syndrome.

Additionally, in January 2020, Ovid Therapeutics, a well-known player in rare neurological diseases treatment market, announced the enrollment of patients for pivotal Phase 3 NEPTUNE trial associated with Angelman syndrome.The results of this research study are expected in mid-2020.

Such increasing awareness and developments for rare neurological diseases are likely to boost the growth of the market during the forecast period.The global rare neurological disease treatment market is segmented into indication, drug type, distribution channel, and mode of administration.The rare neurological disease treatment market, by indication, is further segmented into narcolepsy, amyotrophic lateral sclerosis, Alzheimer's disease, multiple sclerosis, spinal muscular atrophy (SMA), Duchene muscular dystrophy, and other indication.

Based on drug type, the rare neurological disease treatment market is further segmented into organic compounds and biologics.Based on distribution channel, the market is further segmented into online pharmacies, hospital pharmacies, and retail pharmacies.

The mode of administration segment is classified into oral, injectables.Some of the essential primary and secondary sources included in the report are Food and Drug Administration, World Health Organization (WHO), Center for Drug Evaluation and Research, Canada Foundation of Innovation, European Federation of Pharmaceuticals Industries Associations, and International Trade Administration.

Read the full report: https://www.reportlinker.com/p05882129/?utm_source=PRN

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The global rare neurological disease treatment market is expected to reach US$13,830.96 million by 2027 from US$ 7,300.12 million in 2019 - Yahoo...

Bill Gates and other philanthropists from the US have granted the Imperial College London and the UK Dementia Research Institute a $1.5 million grant to put to the test their new technology for Alzheimer's disease.

The neurologists chose 24 Alzheimer's disease patients in their early stages to participate in the therapy. Experts have high hopes for this trial after dozens of dementia drugshave failed tests.

(Photo: Wikimedia Commons)PET scan of a human brain with Alzheimer's disease

Neurologists from Imperial College London and the UK Dementia Research Institute received a $1.5 million grant from Bill Gates and other US philanthropists to start treating Alzheimer's diseaseby sending electrical currents deep in the brain.

The technology is called the temporal interference brain stimulation, which will be participated by 24 patients with early-stage Alzheimer's disease. Electrodes will be attached to their scalp during the trial that will last for two weeks with daily hour-long sessions.

The electrodes will be sending two harmless-high-frequency electric currents, 2,000 Hz and 2,005 Hz, into the brain. When these two slightly different frequencies meet, they create a third current that is a low-frequency wave of 5 Hz.

Neurologists are hoping that this third electric current will make a difference in the treatment of dementia. The frequency will be triggered in an area deep in the brain responsible for new memories, called the hippocampus.

Hopefully, the process would revive the mitochondria in that area of the brain. Mitochondriais the powerhouse of a cell that becomes damaged when a person has Alzheimer's disease.

Unlike the two original beams, the third frequency is not too high a frequency to interfere with the healthy brain tissue. It will only have a similar rate at which the brain cells fire that allows them to spark the affected neurons back to life.

The researchers also tested their new technology on healthy patients. They found an increased blood flow in the brain and improved facial-recognition results.

But it will be the first time to test the new technology on patients with Alzheimer's disease that is scheduled in January next year.

Read Also: No to Dementia: Drink Red Wine, Eat Dark Chocolates and Other Flavonoid-Rich Foods

The new technology which aims to treat Alzheimer's disease will target the mitochondria that are damaged by the disease. According to researcher Dr. Nir Grossman, more and more evidence has come to light that mitochondrial dysfunction has a vital role in the progression of Alzheimer's disease.

He added that this is an essential milestone in their research after years of studying and working on breakthrough technology.

An estimated 850,000 people in the United Kingdom have dementia, and among these numbers around 500,000 have Alzheimer's disease.

Bill Gates, Mikey Hoag, and the US Alzheimer's Association have given 16 grants to different institutions including this new trial, with a total of $60 million as part of their Cloud Program.

Gates said that finding a treatment for dementia needs increased and continued research after witnessing first-hand what dementia could do to people.

Read More: Living Alone in Your 50s and 60s? Dementia Found to Be 30% More Likely: Study

Check out more news and information on Alzheimer's Disease in Science Times.

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Neurologists Are Treating Alzheimer's Disease by Sending Electrical Currents Deep in the Brain - Science Times

The following article is part of conference coverage from the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event. Neurology Advisors staff will be reporting breaking news associated with research conducted by leading experts in neurology. .

While both recognize the importance of a telemedicine approach, patients with multiple sclerosis (MS) appear more prepared and ready to use telemedicine than their physicians during the coronavirus disease 2019 (COVID-19) pandemic, according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.

During the COVID-19 era, patients and clinicians alike increased their use of telemedicine platforms, particularly for routine evaluations that do not require in-person office visits. Study researchers sought to understand the acceptability and satisfaction of telemedicine among patients with MS and the neurologists who care for them.

This study consisted of a brief survey which was administered to a group of patients with multiple sclerosis and their neurologists at an MS center of a hospital in Milan, Italy. 151 patients completed the survey. Approximately 75% of the patient cohort consisted of women. The mean age of participants was 42.2 years, and the median Expanded Disability Status Scale was 1.5. Treatments included interferon (10%), glatiramer acetate (10%), teriflunomide (14%), dimethylfumarate (22%), fingolimod (23%), cladribine (3%), alemtuzumab (8%), and ocrelizumab (10%).

87% of patients said that they appreciated telemedicine during the COVID-19 pandemic. Contrastingly, responses from 82% supported traditional in-office evaluations and their importance in clinical care. Less than half (44%) of participants said that they would alternate in-person and remote telemedicine visits, whereas 38% strongly preferred traditional evaluations. About 10% held a positive opinion of telemedicine but required traditional evaluations. Only 3% of respondents were not satisfied with telemedicine.

The primary reasons given for the strong preference toward in-person evaluations included the need for human empathy with the neurologist, as well as the belief that in-person examinations would lead to better clinical outcomes. Only 18% of respondents said that they would always use telemedicine except if an acute event occurred.

None of the 18 neurologists and residents surveyed said that they would use telemedicine as their only tool for evaluating patients. One-third (33%) of clinicians said that they would alternate telemedicine visits with traditional evaluations, whereas 67% said they would use remote visits only in special situations.

Visit Neurology Advisors conference section for continuous coverage from the ACTRIMS/ECTRIMS MSVirtual2020 Forum.

Reference

Moiola L, Cristinzi MD, Guerrieri S, et al. Telemedicine in/outside the pandemic: a survey about satisfaction of this tool in a cohort of multiple sclerosis patients and their neurologists. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 20120. Abstract P0666.

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Patients With MS More Ready to Use Telemedicine Than Their Neurologists - Neurology Advisor

XconomyBoston

The blood-brain barrier protects the functioning of that essential organ, but its also a hurdle to delivering neurological drugs.

Italys Chiesi Group has agreed to pay Guilford, CT-based Bioasis Technologies $3 million up front to use the preclinical firms technology to facilitate the delivery of enzymes across the blood-brain barrier to treat neurological symptoms associated with four lysosomal storage disorders (LSDs). Such diseases are caused by mutations in the genetic instructions for important enzymes that normally help our cells clear out waste. Without those enzymes, toxic materials build up in the bodys cells over time.

Under the agreement Chiesi is responsible for R&D and commercialization costs associated with the programs. Bioasis is eligible for up to $138 more in milestone payments, plus royalties on net sales of any product Chiesi commercializes using its technology. In exchange Chiesi gets the rights to what Bioasis calls its xB3 platform, the technology the company is developing for the delivery of therapeutics across the blood-brain barrier and the treatment of central nervous system disorders.

Bioasis says its xB3 technology uses a process called receptor-mediated transcytosis and a human transport protein, melanotransferrin, to move molecules across the blood-brain-barrier. The company says that in preclinical studies, this method was able to ferry molecules of varying sizes and types into the brain.

Enzyme replacement therapy is used to treat some LSDs, but neurological complications of the disorders remain largely unaffected even when other affected parts of the body respond to the treatment, according to Bioasis CEO Deborah Rathjen.

The unique delivery method of [Bioasiss] xB3 platform has the potential to overcome a significant challenge in the treatment of many neurological disorders, which is the ability to cross the blood-brain barrier, said Giacomo Chiesi, who heads the companys Boston-based rare disease unit Chiesi, which launched in February.

The BioMarin Pharmaceuticals (NASDAQ: BMRN) drug erliponase alfa (Brineura), for example, which was approved in 2017 to treat a group of degenerative neurometabolic disorders caused by an enzyme deficiency, must be administered directly into the brain through a stent.

Chiesi isnt disclosing the specific LSDs it is targeting. Nearly 50 exist, according to the National Organization for Rare Disorders. For most LSDs no or few treatment options exist.

The companies described their new partnership as a strategic alliance focused on rare diseases.

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases - Xconomy

Anchorage, Alaska U.S. Attorney Bryan Schroder announced Freiday that Anchorage-based Alaska Neurology Center LLC and its owner, Franklin Ellenson, M.D., have agreed to pay $2 million to resolve False Claims Act allegations that the medical practice knowingly submitted false billing claims to federal healthcare programs. Contemporaneous with the civil settlement, Alaska Neurology Center LLC and Dr. Ellenson agreed to a three-year Integrity Agreement with the U.S. Department of Health and Human Services.

Healthcare providers who submit false bills hurt honest providers and the nations taxpayers, said U.S. Attorney Schroder. I commend the collaborative efforts of our federal partners to use all available remedies, both civil and criminal, to address waste and abuse in the healthcare market. I am particularly pleased that the public healthcare programs will be made whole, which will help ensure their continued vitality for future generations.

The settlement resolves allegations that, from March 2013 through June 2018, Alaska Neurology Center LLC engaged in multiple fraudulent billing schemes, including: (1)submitting claims with false dates of service in order to obtain reimbursement beyond program caps, (2)submitting claims for infusion services provided by an unqualified medical assistant, (3)submitting claims for physical therapy when the service provided was non-reimbursable massage therapy, (4)submitting claims using multiple, unbundled billing codes, rather than a single required billing code, to obtain overpayment for the service, (5)submitting claims with false names of performing and/or referring medical providers, and (6)re-submitting claims with false service or diagnosis information, and without consulting a medical provider, after an original claim was rejected.

The allegations stem from a lawsuit filed under the whistleblower, orqui tam, provision of the False Claims Act, which allows private parties to bring suit on behalf of the government and to share in any recovery. The whistleblower will receive approximately $380,000 of the settlement.

The governments pursuit of this matter illustrates the governments emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the U.S. Department of Health and Human Services at 1-800-HHS-TIPS (800-447-8477) orhttps://oig.hhs.gov/fraud/report-fraud.

The settlement was the result of an investigation conducted by the Civil Division of the U.S. Attorneys Office for the District of Alaska, in conjunction with the U.S. Department of Health and Human Services Office of Inspector General. Investigative support was also provided by the Defense Health Agency, U.S. Office of Personnel Management, U.S. Department of Veterans Affairs, and the Federal Bureau of Investigation.

The claims resolved by this settlement are allegations only, and there has been no determination of liability. The lawsuit is captionedUnited States of America ex rel. Thomas Fidler v. Alaska Neurology Clinic, LLC [sic], et al., No. 3:18-cv-00057-HRH (D. Alaska).

Source:DOJ

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Alaska Neurology Center LLC and Its Owner to Pay $2 Million to Settle False Claims Act Allegations Regarding Fraudulent Medical Billing - Alaska...