The Challenges of Maintaining Telehealth Access in a… : Neurology Today – LWW Journals

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Many of the state policies and regulations that enabled greater flexibility about access to telehealth across state lines have been retracted as COVID-19 rules and mandates relax. The patchwork of varying policies regarding telemedicine has prompted a call for more streamlined pathways to interstate credentialing for physicians who see patients in other states.

Neurologists at Wake Forest Baptist Health in Winston-Salem, NC, never used to get this kind of call, but it's happening more and more these days. A patient from a town like Blacksburg, VA, nearly two-and-a-half-hour's drive away will travel just over the border into North Carolina, seek out a parking lot with good cell reception or Wi-Fi, and connect via the health system's electronic medical record patient portal to their Wake Forest stroke specialist or epileptologist.

Our catchment area includes southern Virginia and West Virginia, said vascular neurologist Amy K. Guzik, MD, an associate professor of neurology at Wake Forest. Many of our patients have mobility and transportation limitations and may require a care partner or other person to drive them to the clinic. When telehealth limitations were lifted during the height of the COVID-19 pandemic in 2020, that was really beneficial for these patients, especially for follow-up appointments, and we were hoping that would continue. Now we have to ask each patient what state they are in before we are able to see them.

States of emergency issued by state and local governments in 2020 have gradually been lifted over the past year, and with them, temporary waivers allowing doctors licensed in one state to provide care to patients in other states via telemedicine.

As of October 6, 2021, the Federation of State Medical Boards (FSMB) reported that 18 states still had such waivers in place, while 32 states plus the District of Columbia no longer have waivers. Virginia's waiver, for example, expired in June 2021, but West Virginia's is still in place.

The geographic boundaries are so arbitrary, said Dr. Guzik. If a patient is 10 miles in one direction, I can't see them, but if they're 10 miles in another direction, I can.

The patchwork of emergency orders has created confusion for providers and health systems around the country, said Lisa Robin, FSMB's chief advocacy officer.

A few states have made their waivers permanent, while others have allowed them to expire. A lot of bills are being introduced surrounding telehealth in state legislatures, with licensure and credentialing being a key piece, but also credentialing of facilities and broadband and infrastructure resources to support telehealth. We expect a busy state legislative session. (Federal waivers that allow Medicare billing for both video and audio-only telehealth services remain in place at press time.)

For some neurologists and their patients, the end of the licensure waivers in some states has not proven particularly burdensome.

Here at NYU, for example, our out-of-state patients are frequently in Florida, because a lot of people go from New York to Florida for the winter, said Neil A. Busis, MD, FAAN, clinical professor of neurology at the NYU Grossman School of Medicine, associate chair for technology and innovation in the department of neurology, and clinical director of the telehealth program.

Florida makes it extremely easy to get a pure telehealth license; the process literally takes like half an hour. We also have many patients from Connecticut, which has the relaxed requirements for telehealth in place until June 2023, and New Jersey, which has made it fairly easy to get a temporary telehealth-only license with policies that are in place through the middle of January 2022.

But in neurology deserts like the Mountain West comprising Wyoming, Utah, New Mexico, Nevada, Montana, Idaho, Colorado, and Arizona, and for patients with rare conditions for whom there are only a handful of centers of excellence across the country, the waivers had provided access to expert neurologic care that would otherwise have been all but inaccessible. This was true, particularly given that travel can be burdensome for people with conditions such as epilepsy, Parkinson's, and Alzheimer's disease; post-stroke patients; and children with rare neurologic conditions.

The Child Neurology Foundation has had a series of strategic discussions this year on the role of telehealth in child neurology, said Dr. Busis. Imagine that you're at home with a child who has frequent seizures and may be on a ventilator and require frequent suctioning. You have a lot of supportive equipment that has to be with you at all times. It can take hours to pack up a medically fragile child for a visit to a specialized center an hour or more away, and if you're halfway there and the child has a seizure, what do you do? In the cases of these children, and other people who may be on home ventilation or other significant supportive care, it's not just I can't miss work today, it's life-altering. It's a quality of care issue.

As a stroke specialist, Dr. Guzik said she has found that telehealth is particularly beneficial for transitions of care as patients are discharged from the hospital to home and are adjusting to a new set of limitations.

After they're home for a couple of weeks, we want to check in and see how they're doing, she said. Maybe they do need that physical therapist they didn't think they needed at discharge, or the occupational therapist to help them modify their home. But it's difficult when you've just gotten home to turn around and go back to the medical center with your caregiver, especially if you're in a different state.

One potential solution to the licensure challenge is the Interstate Medical Licensure Compact (IMLC), which offers a voluntary, expedited pathway to licensure for physicians who wish to practice in multiple states. First launched in 2017, the Compact now has 33 member states and two member jurisdictions; Ohio became the 33rd state in July 2021.

Eligible physicians can qualify to practice medicine in multiple states by completing just one application within the Compact, receiving separate licenses from each state in which they intend to practice, according to the IMLC's website. These licenses are still issued by the individual statesjust as they would be using the standard licensing processbut because the application for licensure in these states is routed through the Compact, the overall process of gaining a license is significantly streamlined. Physicians receive their licenses much faster and with fewer burdens.

The FSMB strongly supports the IMLC, said Robin. We had expected that the number of licenses issued would fall off as the pandemic began to wane, but it has not. More states are joining the Compact and going live. With Texas and Ohio having joined the Compact this year, that's a lot of additional eligible physicians. We are going to work hard to try to get additional states to join.

The FSMB is also working on a new telemedicine policy to replace the one originally issued in 2014. The draft is expected to be released by the end of 2021, and will be voted on at the Federation's 2022 Annual Meeting in April. We are hoping to come to consensus on a very much expanded policy that addresses questions about licensure, modalities, continuity of care, and many other areas, Robin said.

In a telehealth position statement published in Neurology in August, the AAN called for a number of steps to make telehealth more accessible and equitable for all patients. Licensing, prescribing, and related policies should be simplified, the authors noted. A desirable solution could include blanket reciprocity and an expedited licensing process that would require one unrestricted state license, a new background check for each state in which telemedicine is practiced, and reduced annual fees for limited practices. This would ensure protection of patients' rights to receive telehealth services as they require.

Telehealth should be here to stay, said Riley Bove, MD, associate professor of neurology at the UCSF Weill Institute for Neurosciences in San Francisco and a co-author of the AAN telehealth statement. It reduces the barriers to care, reduces patient costs for a visit, and decreases the burden of specialty visits for patients who are navigating multiple conditions. And during the pandemic, we have learned that this is broadly doable.

Before COVID-19, we had many colleagues who said that you can't provide good neurologic care via video. Through the past year and a half, however, we have become experts in examining patients via video and learned what is more and less beneficial, and what are the use cases where we need the patients to come in versus where we can spare them that trip and expense.

Lobbying for more streamlined pathways to interstate credentialing can be challenging, however. When I talk to our state legislators, they're mostly concerned about the patients in their own state and their constituents there, so they could say, Well, we want our own doctors in our own state to see the patients here, Dr. Guzik said.

Of course we do want the best, closest neurologist to see these patients, but there are situations with certain conditions or subspecialties or locations where it just makes more sense to see an expert in another state. Telehealth allows us to meet our patients where they are, let them live their lives and also get good medical care.

Certain cases are definitely not appropriate for telehealth, Dr. Bove acknowledged. And in others, it's just about patient preference. I have some patients who have said, Please, I just want to see you in person again. But there are others who never want to come back in person because they find telehealth so convenient. The reason most medical care happens in the clinic is not because that's where it's always best provided, but because it's most convenient for the clinician.

The patchwork of state policies and regulations regarding licensure, and variable payment reimbursements for telehealth reflects so much that is difficult about health care in America, Dr. Bove said. It underscores the major flaws in our health care system. And it needs to be changed.

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The Challenges of Maintaining Telehealth Access in a... : Neurology Today - LWW Journals

Outlook on the Neurology Clinical Trials Global Market to 2028 – Size, Share & Trends Analysis Report – Yahoo Finance

DUBLIN, Nov. 2, 2021 /PRNewswire/ -- The "Neurology Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional, Observational, Expanded Access), By Indication, By Region, and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

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The global neurology clinical trials market size is expected to reach USD 7.4 billion by 2028. The market is expected to expand at a CAGR of 5.5% from 2021 to 2028.

This is largely attributed to big pharma companies conducting innovative trials in neurology, increased government funding from the National Institute of Neurological Disorders and Stroke (NINDS), and stringent regulatory requirements pertaining to clinical trials.

Neuroscience continues to receive a healthy level of early investment. It received USD 1.5 billion in venture capital funding in 2018, second only to cancer, indicating that investors expect a large pharma acquisition to pay off in the near future. As the industry strives to move past the many late-stage clinical failures of recent years, early diagnosis of diseases is attracting investment and driving deal-making in the complex neuroscience sector, particularly for pain and Alzheimer's disease.

In terms of deal volume, no other therapy area comes close to matching oncology, but neuroscience is among the nearest contenders. Despite a drop in total expected value in 2017, the number of neuroscience-related licensing deals has gradually climbed over the last decade.

The vast majority of neuroscience agreements ~90%have a primary neurological focus, which corresponds to the level of R&D activity in the two disciplines.

Many experimental therapeutics require dosage by on-site administration and carefully scheduled outcome measure evaluations hence, the COVID-19 pandemic has significantly harmed the implementation of the precise procedures required to establish proof of safety and efficacy.

Story continues

The COVID-19 has resulted in the shutdown of the network of centers conducting stroke clinical trials. This was followed by a phased research restart plan that took local circumstances and regulatory oversight into account. This approach was successful in a reengaging research effort to some extent in all but one of the ongoing investigations within 55 days.

Neurology Clinical Trials Market Report Highlights

The phase II segment dominated the market and accounted for a maximum revenue share of 36.7% in 2020. Between 1999 and 2020, 8,205 CNS trials were conducted, with 609 trials being conducted in 2020.

The interventional segment held the largest market revenue share of 81.1% in 2020.

The Huntington's disease segment is anticipated to register the fastest CAGR of 6.0% over the forecast period. This is largely due to the high prevalence of the disease around the world.

North America dominated the market and accounted for a revenue share of 45.8% in 2020. The rising prevalence of neurological disorders and the presence of a large number of players in clinical trials drive the market in the region.

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary

Chapter 3 Neurology Clinical Trials Market: Variables, Trends, & Scope3.1 Market Segmentation and Scope3.2 Market Dynamics3.2.1 Market Driver Analysis3.2.1.1 Increasing neurological disease, such as dementia, stroke, and peripheral neuropathy3.2.1.2 Increasing R&D investments3.2.1.3 Stringent Regulatory Requirements3.2.2 Market Restraint Analysis3.2.2.1 High Failure Rates of Trials3.2.2.2 Rising Cost of Clinical Trials3.3 Penetration & Growth Prospect Mapping3.4 COVID-19 Impact on the Market3.5 Major Deals and Strategic Alliances Analysis3.6 Neurology Clinical Trials: Market Analysis Tools3.6.1 Industry Analysis - Porter's3.6.3 PESTEL Analysis

Chapter 4 Neurology Clinical Trials Market: Phase Segment Analysis4.1 Neurology Clinical Trials Market: Phase Market Share Analysis, 2020 & 20284.2 Phase I4.2.1 Phase I Market, 2016 - 2028 (USD Million)4.3 Phase II4.3.1 Phase II Market, 2016 - 2028 (USD Million)4.4 Phase III4.4.1 Phase III Market, 2016 - 2028 (USD Million)4.5 Phase IV4.5.1 Phase IV Market, 2016 - 2028 (USD Million)

Chapter 5 Neurology Clinical Trials Market: Study Design Segment Analysis5.1 Neurology Clinical Trials Market: Study Design Market Share Analysis, 2020 & 20285.2 Interventional5.2.1 Interventional Market, 2016 - 2028 (USD Million)5.3 Observational5.3.1 Observational Market, 2016 - 2028 (USD Million)5.4 Expanded Access5.4.1 Expanded Access Market, 2016 - 2028 (USD Million)

Chapter 6 Neurology Clinical Trials Market: Indication Segment Analysis6.1 Neurology Clinical Trials: Indication Market Share Analysis, 2020 & 20286.2 Epilepsy6.2.1 Epilepsy Market, 2016 - 2028 (USD Million)6.3 Parkinson's Disease6.3.1 Parkinson's Disease Market, 2016 - 2028 (USD Million)6.4 Huntington's Disease6.4.1 Huntington's Disease Market, 2016 - 2028 (USD Million)6.5 Stroke6.5.1 Stroke Market, 2016 - 2028 (USD Million)6.6 Traumatic Brain Injury6.6.1 Traumatic Brain Injury Market, 2016 - 2028 (USD Million)6.7 Amyotrophic Lateral Sclerosis6.7.1 Amyotrophic Lateral Sclerosis Market, 2016 - 2028 (USD Million)6.8 Muscle regeneration6.8.1 Muscle regeneration Market, 2016 - 2028 (USD Million)6.9 Others6.9.1 Others Market, 2016 - 2028 (USD Million)

Chapter 7 Neurology Clinical Trials Market: Regional Analysis

Chapter 8 Company Profiles8.1 IQVIA8.1.1 Company Overview8.1.2 Service Benchmarking8.1.3 Financial Performance8.1.4 Strategic Initiatives8.2 Novartis8.2.1 Company Overview8.2.2 Financial Performance8.2.3 Service Benchmarking8.2.4 Strategic Initiatives8.3 Covance8.3.1 Company Overview8.3.2 Service Benchmarking8.3.3 Strategic Initiatives8.4 Medpace8.4.1 Company Overview8.4.2 Financial Performance8.4.3 Service Benchmarking8.5 Charles River Laboratories8.5.1 Company Overview8.5.2 Financial Performance8.5.3 Service Benchmarking8.6 Icon Plc8.6.1 Company Overview8.6.2 Financial Performance8.6.3 Service Benchmarking8.7 GlaxoSmithKline8.7.1 Company Overview8.7.2 Financial Performance8.7.3 Service Benchmarking8.7.4 Strategic Initiatives8.8 Aurora healthcare8.8.1 Company Overview8.8.2 Financial Performance8.8.3 Service Benchmarking8.9 Charles River Laboratories8.9.1 Company Overview8.9.2 Financial Performance8.9.3 Service Benchmarking8.9.4 Strategic Initiatives8.10 Biogen8.10.1 Company Overview8.10.2 Financial Performance8.10.3 Service Benchmarking8.10.4 Strategic Initiatives

For more information about this report visit https://www.researchandmarkets.com/r/c0upuj

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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Outlook on the Neurology Clinical Trials Global Market to 2028 - Size, Share & Trends Analysis Report - Yahoo Finance

Delays in thrombolysis during COVID-19 are associated with worse neurological outcomes: the Society of Vascular and Interventional Neurology…

This article was originally published here

J Neurol. 2021 Jul 31. doi: 10.1007/s00415-021-10734-z. Online ahead of print.

ABSTRACT

INTRODUCTION: We have demonstrated in a multicenter cohort that the COVID-19 pandemic has led to a delay in intravenous thrombolysis (IVT) among stroke patients. Whether this delay contributes to meaningful short-term outcome differences in these patients warranted further exploration.

METHODS: We conducted a nested observational cohort study of adult acute ischemic stroke patients receiving IVT from 9 comprehensive stroke centers across 7 U.S states. Patients admitted prior to the COVID-19 pandemic (1/1/2019-02/29/2020) were compared to patients admitted during the early pandemic (3/1/2020-7/31/2020). Multivariable logistic regression was used to estimate the effect of IVT delay on discharge to hospice or death, with treatment delay on admission during COVID-19 included as an interaction term.

RESULTS: Of the 676 thrombolysed patients, the median age was 70 (IQR 58-81) years, 313 were female (46.3%), and the median NIHSS was 8 (IQR 4-16). Longer treatment delays were observed during COVID-19 (median 46 vs 38 min, p = 0.01) and were associated with higher in-hospital death/hospice discharge irrespective of admission period (OR per hour 1.08, 95% CI 1.01-1.17, p = 0.03). This effect was strengthened after multivariable adjustment (aOR 1.15, 95% CI 1.07-1.24, p < 0.001). There was no interaction of treatment delay on admission during COVID-19 (pinteraction = 0.65). Every one-hour delay in IVT was also associated with 7% lower odds of being discharged to home or acute inpatient rehabilitation facility (aOR 0.93, 95% CI 0.89-0.97, p < 0.001).

CONCLUSION: Treatment delays observed during the COVID-19 pandemic led to greater early mortality and hospice care, with a lower probability of discharge to home/rehabilitation facility. There was no effect modification of treatment delay on admission during the pandemic, indicating that treatment delay at any time contributes similarly to these short-term outcomes.

PMID:34333701 | DOI:10.1007/s00415-021-10734-z

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Delays in thrombolysis during COVID-19 are associated with worse neurological outcomes: the Society of Vascular and Interventional Neurology...

Costantino Iadecola, MD, FAHA, of Weill Cornell Medicine to be recognized with the American Heart Association’s 2021 Basic Research Prize – EurekAlert

Embargoed until 7 a.m. CT / 8 a.m. ET Wednesday, Nov. 3, 2021

DALLAS, Nov. 3, 2021 The American Heart Association (AHA), a global force for longer, healthier lives, will present its 2021 Basic Research Award to Costantino Iadecola, M.D., FAHA, of Weill Cornell Medicine in New York City, in recognition of his outstanding work in cerebrovascular biology, particularly in the areas of stroke and dementia. He will receive the award during the Presidential Session on Sunday, Nov. 14 during the AssociationsScientific Sessions 2021. The meeting will be fully virtual, Saturday, Nov. 13 through Monday, Nov. 15, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

Dr. Iadecola is a board-certified neurologist whose research focuses on ischemic brain injury, neurodegeneration and cognitive impairment. He is the director and chair of the Feil Family Brain and Mind Research Institute and the Anne Parrish Titzell Professor of Neurology at Weill Cornell Medicine in New York City. He was selected for the Associations 2021 Basic Research Award in recognition of his research in the areas of cerebrovascular biology, stroke and dementia.

Dr. Costantino Iadecolas ground-breaking research in neurology, including developing the concept of the neurovascular unit to better understand the causes of stroke and dementia and opening more possible methods of treatment, makes him a true leader at the forefront of his field, significantly impacting how we think about prevention, diagnosis and treatment of neurovascular and neurodegenerative diseases, said Association President Donald M. Lloyd-Jones, M.D., Sc.M., FAHA. Im thrilled to honor him, his work and his commitment to neurovascular research.

Dr. Iadecola is recognized to have pioneered and validated the concept of the neurovascular unit, a widely accepted notion that neurons and cerebrovascular cells work together to maintain the health of the brain. This concept inspired new research on mechanisms that regulate cerebral perfusion and on how their failure causes brain diseases. His discovery of the cerebrovascular effects of the amyloid-beta peptide and tau established that neurovascular dysfunction is an early biomarker for Alzheimers disease. His research demonstrates a relationship between innate immunity and the deleterious effects of hypertension on neurovascular regulation and cognitive function and found that high-salt diets cause dementia through the Alzheimer protein tau, bridging the age-old gap between neurovascular and neurodegenerative diseases. Dr. Iadecolas work also details how microbiota of the gut can influence a patients susceptibility to ischemic stroke.

I am honored to receive the Basic Research Prize, which I humbly accept on behalf of my mentors, colleagues and collaborators, said Dr. Iadecola. I am grateful to the American Heart Association for the continued support I received since the very beginning of my clinician-scientist career.

Dr. Iadecola earned his medical degree from the University of Rome, Italy. He first came to the U.S. in the 1980s as a post-doctoral fellow in neurobiology at Weill Cornell Medicine, New York. After completing a neurology residency at New York-Presbyterian/Weill Cornell Medical Center in 1990, he joined the University of Minnesota Medical School as an assistant professor in Neurology before returning to New York City as a professor of neurology and neuroscience at Weill Cornell Medicine, where he has been for the past 20 years.

His work has earned accolades from the AHA, the American Academy of Neurology, the National Institutes of Health and the Alzheimers Association. He was previously recognized by the Association with its 2009 Willis Lecture Award, given in recognition of his contributions to the role of prostaglandins and nitric oxide in stroke damage and to the role of cerebral blood vessel dysfunction in Alzheimer's disease. He won the 2015 Excellence Award in Hypertension Research from the Association in recognition of his research connecting hypertension and Alzheimers disease. He was honored again by the Association with a 2019 Distinguished Scientist Award to recognize his research contributions to cardiovascular disease, stroke and dementia. Additionally, in 2011 the Alzheimers Association recognized Dr. Iadecola with the Zenith Fellow Award, which is prestigious worldwide recognition in Alzheimers research.

His research has been documented in nearly 400 papers published in peer-reviewed journals and he is listed by Clarivate Analytics as one of most highly cited researcher in the world in his field. He has been a guest editor for theHypertension,CirculationandProceeding of the National Academy of Sciencesjournals and a member of the editorial boards forCirculation Research,Journal of Cerebral Blood Flow and Metabolism,Cerebrovascular Diseases,Annals of Neurology,Cellular and Molecular Neurobiologyand theInternational Journal of Stroke.(Note:Hypertension,CirculationandCirculation Researchare published by the American Heart Association.)

Additional Resources:

The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers and health insurance providers and the Associations overall financial information are availablehere.

The American Heart AssociationsScientific Sessions 2021is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care professionals worldwide. The three-day meeting will feature more than 500 sessions focused on breakthrough cardiovascular basic, clinical and population science updates in a fully virtual experience Saturday, Nov. 13 through Monday, Nov. 15, 2021. Thousands of leading physicians, scientists, cardiologists, advanced practice nurses and allied health care professionals from around the world will convene virtually to participate in basic, clinical and population science presentations, discussions and curricula that can shape the future of cardiovascular science and medicine, including prevention and quality improvement. During the three-day meeting, attendees receive exclusive access to more than 4,000 original research presentations and can earn Continuing Medical Education (CME), Continuing Education (CE) or Maintenance of Certification (MOC) credits for educational sessions. Engage in Scientific Sessions 2021 on social media via#AHA21.

About the American Heart Association

The American Heart Association is a leading force for a world of longer, healthier lives. With nearly a century of lifesaving work, the Dallas-based association is dedicated to ensuring equitable health for all. We are a trustworthy source empowering people to improve their heart health, brain health and well-being. We collaborate with numerous organizations and millions of volunteers to fund innovative research, advocate for stronger public health policies, and share lifesaving resources and information. Connect with us onheart.org,Facebook,Twitteror by calling 1-800-AHA-USA1.

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Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Costantino Iadecola, MD, FAHA, of Weill Cornell Medicine to be recognized with the American Heart Association's 2021 Basic Research Prize - EurekAlert

This Colombian Researcher Helps Reveal The True Cost Of Strokes – Forbes

Garzon, who is a Research Fellow at the Department of Neurology at the International Hospital of ... [+] Colombia in Piedecuesta, Santander, in eastern Colombia

Colombian doctor Jenny Garzon's day-to-day work involves (under the supervision of neurologists), treating patients , who have suffered from stroke, but she is also a medical researcher helping to put a number on the financial toll of strokes and not just on the patient.

Garzon, who is a research fellow at the Department of Neurology at the International Hospital of Colombia Piedecuesta, Santander in eastern Colombia, says that relatively little research has been done in Colombia into the care burdens and additional costs caused by stroke (when the blood supply to part of the brain is cut off).

"If someone has a stroke, the costs can really add up: there can be structural changes to the home, wheelchairs and more," Garzon says, adding that in Colombia, these new costs can add up to an entire monthly minimum wage or more, as neither the public health system nor private insurers usually cover the majority of these expenses in the long-term.

Garzon, who is part of a team putting together a new, as-yet-unpublished paper on the topic of the financial impacts on stroke patients and their families and care-givers, says the impact extends far beyond these medical costs.

"With these medical costs, the loss of the income of the stroke patient and usually the need for a full-time carer, you are basically looking at the loss of two to three individual wages, depending on the patient," Garzon says, "One option to fix this could be new public policies that would allow the government to cover those costs during the time the patient is in the process of rehab."

Garzon, 24, says the other solution is prevention through education and rapid response.

"Most stroke patients have much better outcomes if they can arrive at a hospital or clinic within four and a half hours," she says, adding that "telestroke" treatment, the usage of remote technology to get stroke patients treated by neurologists, doctors who have advanced training in the field, can help reduce response times even further. It is not yet available in Colombia.

Garzon says that a significant proportion of people in Colombia are not aware of how to identify the main symptoms of stroke: They can't speak well, one side of the face is numb or limbs can't move.

If people learn about stroke first signs and symptoms, then they can ask for help quickly and potentially reduce the serious health impacts after a stroke," she says.

Garzon grew up in Santander, the same department (state) where she now works.

"I've always loved everything to do with the human body," Garzon says, adding that while studying her undergraduate medical degree, she fell in love with clinical research, particularly as it pertains to brains.

"In my early path as a researcher, I've been under the mentorship of many people who have believed in me," Garzon says, adding she especially learned from neurologists Gustavo Pradilla and Federico Silva.

Garzon says the identifying and lowering costs for stroke patients is not just key in Colombia, but for patients across the entire world.

"Something that is very lovely about research is that we can do many collaborations, because not just one region has all the answers," she says, "We can do collaborations between Colombia and any other country in the world, it will make the research stronger."

Colombian neurology researcher Jenny Garzon (fifth from the left) with students and professors ... [+] during an International Brain Research Organization event in Medellin, Colombia.

A husband and wife team of Colombian scientists are also helping to improve lives through studying brain cells.

Marlene Jimenez and Carlos Velez at the University of Antioquia in Medellin, Colombia, have observed Alzheimer's precursor molecules in cells taken from newborns.

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This Colombian Researcher Helps Reveal The True Cost Of Strokes - Forbes

News University of California Health hospitals recognized among the best in California and the nation – University of California

University of California HealthThursday, July 29, 2021

The hospitals of University of California Health (UCH) once again have been rated among the best in the state and the nation, according toU.S. News & World Reports 2021-2022 Best Hospitals rankings.

UCLA Health is recognized on the Best Hospitals Honor Roll as the third best in the nation and first in California. UCSF Health is ninth nationally and first in Northern California. All five UC academic health centers that own or operate hospitals were among the best in the state out of 416 California hospitals evaluated.

UCH hospitals further distinguished themselves by being nationally ranked in two or more specialties. Only 140 of the more than 1,800 hospitals eligible for the analysis were ranked in the top 50 in one or more specialty. The neurology and neurosurgery program at UCSF Health is ranked first in the nation.

"We have a high concentration of physician and researcher expertise within University of California Health (UCH), and they share that knowledge across the system. That spirit of collaboration keeps us at the forefront of academic medicine and improves our patients quality of care. Dr. Carrie L. Byington, executive vice president of UCH and an infectious disease expert

The rankings for each of the medical centers are:

U.S. News & World Report has been publishing its Best Hospitals report for three decades to help make hospital quality more transparent. The Honor Roll recognizes the top 20 hospitals across the nation that deliver exceptional treatment across multiple areas of care.

The rankings are based on measures such as risk-adjusted survival and discharge-to-home rates, volume and staffing of nursing, among other care-related indicators. Additionally, the report considers input from physicians across the nation who vote for the best hospitals in their specialty.

University of California Health (UCH) comprises six academic health centers, 20 health professional schools, a Global Health Institute and systemwide services that improve the health of patients and the Universitys students, faculty and employees. All of UCs hospitals are ranked among the best in California and its medical schools and health professional schools are nationally ranked in their respective areas.

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News University of California Health hospitals recognized among the best in California and the nation - University of California

3-D ‘Heat Map’ Animation Shows How Seizures Spread in the Brains of Patients with Epilepsy – UCSF News Services

For 29 years, from the time she was 12, Rashetta Higgins had been wracked by epileptic seizures as many as 10 a week in her sleep, at school and at work. She lost four jobs over 10 years. One seizure brought her down as she was climbing concrete stairs, leaving a bloody scene and a bad gash near her eye.

A seizure struck in 2005 while she was waiting at the curb for a bus. I fell down right when the bus was pulling up, she says. My friend grabbed me just in time. I fell a lot. Ive had concussions. Ive gone unconscious. It has put a lot of wear and tear on my body.

Rashetta Higgins at the UCSF Helen Diller Medical Center at Parnassus Heights after surgery to implant more than 150 electrodes to monitor her seizures. Photo courtesy ofRashetta Higgins

Then, in 2016, Higgins primary-care doctor, Mary Clark, at La Clinica North Vallejo, referred her to UC San Franciscos Department of Neurology, marking the beginning of her journey back to health and her contribution to new technology that will make it easier to locate seizure activity in the brain. Medication couldnt slow her seizures or diminish their severity, so the UCSF Epilepsy Center team recommended surgery to first record and pinpoint the location of the bad activity and then remove the brain tissue that was triggering the seizures.

In April, 2019, Higgins was admitted to UCSFs 10-bed Epilepsy Monitoring Unit at UCSF Helen Diller Medical Center at Parnassus Heights, where surgeons implanted more than 150 electrodes. EEGs tracked her brain wave activity around the clock to pinpoint the region of tissue that had triggered her brainstorms for 29 years.

In just one week, Higgins had 10 seizures, and each time, the gently undulating EEG tracings recording normal brain activity jerked suddenly into the tell-tale jagged peaks and valleys indicating a seizure.

To find the site of a seizure in a patients brain, experts currently look at brain waves by reviewing hundreds of squiggly lines on a screen, watching how high and low the peaks and valleys go (the amplitude) and how fast these patterns repeat or oscillate (the frequency). But during a seizure, electrical activity in the brain spikes so fast that the many EEG traces can be tough to read.

We look for the electrodes with the largest change, says Robert Knowlton, MD, professor of Neurology, the medical director of the UCSF Seizure Disorders Surgery Program and a member of the UCSF Weill Institute of Neurosciences. Higher frequencies are weighted more. They usually have the lowest amplitude, so we look on the EEG for a combination of the two extremes. Its visual not completely quantitative. Its complicated to put together.

Enter Jonathan Kleen, MD, PhD, assistant professor of Neurology and a member of the UCSF Weill Institute of Neurosciences. Trained as both a neuroscientist and a computer scientist, he quickly saw the potential of a software strategy to clear up the picture literally.

The field of information visualization has really matured in the last 20 years, Kleen said. Its a process of taking huge volumes of data with many details space, time, frequency, intensity and other things and distilling them into a single intuitive visualization like a colorful picture or video.

Kleen developed a program that translates the hundreds of EEG traces into a 3-D movie showing activity in all recorded locations in the brain. The result is a multicolored 3-D heat map that looks very much like a meteorologists hurricane weather map.

This video shows the OPSCEA (or "Ictal Cinema") technology developed at the UCSF Epilepsy Center. It converts the usual complex "traced-based" recordings of brain waves that doctors see (on the right) into an intuitive heat map projected on the patient's own 3D reconstructed brain (right hemisphere of brain show in main view). Each trace (line) on the right is from a single intracranial electrode (black dots in the brain view). The seizure intensity is calculated automatically from the traces (specifically from the location of the arrow) and converted into color intensity (using a "line length" algorithm), revealing how activity in a given seizure moves in space and time. The technology also applies "slice views" (example shown halfway through the video) so that activity from electrodes deep in the brain can be seen in addition to the brain surface.

The heat maps cinematic representation of seizures, projected onto a 3-D reconstruction of the patient's own brain, helps one plainly see where a seizure starts and track where, and how fast, it spreads through the brain.

The heat map closely aligns with the traditional visual analysis, but its simpler to understand and is personalized to the patients own brain.

To see it on the heat map makes it much easier to define where the seizure starts, and whether theres more than one trigger site, Knowlton said. And it is much better at seeing how the seizure spreads. With conventional methods, we have no idea where its spreading.

Researchers are using the new technology at UCSF to gauge how well it pinpoints the brains seizure trigger compared with the standard visual approach. So far, the heat maps have been used to help identify the initial seizure site and the spread of a seizure through the brain in more than 115 patients.

Kleens strategy is disarmingly simple. To distinguish seizures from normal brain activity, he added up the lengths of the lines on an EEG. Seizures show up as high peaks and low valleys that make their cumulative length quite long, while gently undulating brain waves make much shorter lines. Kleens software translated these lengths into different colors, and the visualization was born.

The technology proved pivotal in Higgins treatment.

Before her recordings, we had feared that Rashetta had multiple seizure-generating areas, Kleen said. But her video made it plainly obvious that there was a single problem area, and the bad activity was rapidly spreading from that primary hot spot.

The journal Epilepsia put Kleens and Knowltons 3-D heat map technology on the cover, and the researchers made their software open-source, so others can improve upon it.

Its been a labor of love to get this technology to come to fruition Kleen said. I feel very strongly that to make progress in the field we need to share technologies, especially things that will help patients.

Higgins has been captivated by the 3-D heat maps of her brain.

It was amazing, she said. It was like, Thats my brain. Im watching my brain function.

And the surgery has been a life-changing success. Higgins hasnt had a seizure in more than two years, feels mentally sharp, and is looking for a job.

When I wake up, Im right on it every morning, she said. I waited for this day for a long, long time.

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3-D 'Heat Map' Animation Shows How Seizures Spread in the Brains of Patients with Epilepsy - UCSF News Services

Examining the Association, Nature of Skin Disorders in Parkinson Disease – AJMC.com Managed Markets Network

AJMC: Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences Medical World News, The American Journal of Managed Care is pleased to welcome Dr Nicki Niemann, neurologist at the Muhammad Ali Parkinson Center and an assistant professor of neurology at Barrow Neurological Institute. Dr Niemann additionally served as a co-author of a review article titled Parkinson's Disease and Skin.

Great to have you on, Nicki. Can you just introduce yourself and tell us a little bit about your work?

Dr Niemann: So, I'm a neurologist by training. I did my training at Baylor College of Medicine in Houston, Texas, and then I did my mood disorders fellowship with the same institution under the mentorship of Dr Joseph Jankovic, who's one of the co-authors on the review article that we're talking about today.

I'm originally from Denmark, where I was born and raised and where I went to medical school at the University of Copenhagen before relocating to first Texas and now here in Phoenix, Arizona, for work.

AJMC: To get us started, can you first speak on the association and nature of skin disorders in Parkinson disease

Dr Niemann: So, not to state the obvious necessarily, but PD is obviously quite a common condition. In fact, it's the second most common neurodegenerative condition after Alzheimer disease. We think of PD many times as a motor disorder because symptoms such as posture, resting tremor, and slowness are quite visible. But there's a whole array of very common and often problematic nonmotor symptoms. That includes not only depression, sleep disorders, constipation, loss of sense of smell, but also skin disorders. And the reason that PD presents with this broad range of symptoms is because it's not just a disorder of the brain itself. It's a multisystem disorder; it affects pretty much the whole body.

There are certain disorders that occur more common in PD than you would expect by chance. In terms of skin, this would be things like changes in sweating, seborrheic dermatitis, melanoma, something called bullous pemphigoid, rosacea, and other conditions. I think the main ones that seem to arise prior to PD are probably changes in sweating. We know that before someone presents with motor features of PD, they can have alterations of the autonomic nervous system, and that can lead to changes in sweat patterns.

Seborrheic dermatitis, which is another common condition that's characterized by redness, scaling, oiliness, sometimes burning pain in the seborrheic areas of the bodyso the scalp, the eyebrows, nasolabial folds, the chest sometimescan also in part be due to autonomic dysfunction, but likely also because of other things such as reduced facial expression or reduced facial movements, changes in hygiene, changes in lipid composition, and changes in the fungi that are on the skin.

Then there's another group of disorders that have perhaps more, or greater, morbidity and where the relationship is much more complex. The main one that people often think of in that regard is melanoma. We've known for several decades now that there is an increased risk of melanoma in PD. There was a recent paper that we referenced in our review article, which was a study done on North American populations in which the risk of melanoma seemed to be 2-and-a halffold greater for people with PD compared with those without.

The exact reason for the association is not completely established, but things like risk factors are shared between PD and melanoma. So, Caucasian race, fair skin, red hair, male gender, pesticide exposure, etc, all increase the risk of both PD and melanoma. There are genes that cause PD that are also found to be mutated in certain melanomasso there's that correlation. There are genes that control melanin synthesis that in parts are pigmentation that can affect your risk of melanomas, but also affect your risk of PD. And then there's also imaging features that are shared between PD and melanoma.

In particular, Im referring to the appearance of the midbrain, which is a structure that's involved in PD. When that structure is evaluated using ultrasound, a so-called hyperechogenic area can be visualized, and that can be seen in PD. It can be used as a biomarker of PD, but actually a lot of people with melanomas, even without PD, can also have similar imaging changes. So that's very interesting.

Lastly, on that note, I'll just mention that there have been reports and concerns, in the past primarily, that levodopa, which is the primary treatment for PD. might increase the risk of melanoma. The reason for that suspicion has been that levodopa is both a precursor to dopamine, which treats PD, but it's also a precursor to melanin, which is found in our skin and melanomas, etc. Several high-level studies, high-quality studies have firmly refuted that there's any association between use of levodopa and development of melanoma.

I won't go into much more detail, but there's also a couple other conditions that are a little bit less common, such as rosacea and bullous pemphigoid, that can also be seen more common in PD.

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Examining the Association, Nature of Skin Disorders in Parkinson Disease - AJMC.com Managed Markets Network

Acute neurologic manifestations in children with hemolytic uremic syndrome linked to increased mortality – 2 Minute Medicine

1. In a largemulti-centerstudy of children with hemolytic uremic syndrome, those with any acute neurologic manifestation (ANM) had increased risk of mortality.

2. Brain infarction, brain hemorrhage, anoxic brain injury, and brain edema were independently associated with mortality.

Evidence Rating Level: 2 (Good)

Study Rundown:Hemolytic uremic syndrome (HUS) is a microangiopathic hemolytic anemia characterized by anemia, thrombocytopenia, and renal dysfunction. One of the most serious complications of HUS is neurologic injury, which can lead to devastating sequelae including death. Previously, only small studies examined acute neurologic manifestations (ANMs) of HUS, with widely varying conclusions. This study characterized ANMs and their association with in-hospital mortality in nearly 4,000 children with HUS using a database containing information from over 40 childrens hospitals in North America. Overall, ANMs occurred in 10.4% of patients. Mortality was significantly higher in patients with any ANM (13.9%) compared to those without an ANM (1.8%). Furthermore, mortality was higher in patients with 2 ANMs (17.6%) than in those with 1 ANM (11.9%). Researchers also examined risk of mortality with specific ANMs and specific combinations of ANMs. One important limitation of this study was the lack of differentiation between typical and atypical HUS, which are considered to be different disease processes. Overall, this robust analysis of data obtained from a large database provides valuable information in identifying which children with HUS are at risk for worse outcomes.

Click to read the study in Pediatrics

Relevant Reading: Neurological involvement in children with E. coli 0104:H4-induced hemolytic uremic syndrome

In-Depth [retrospective cohort]: Data was obtained from the Pediatric Health Information System database, which contains information from over 40 tertiary childrens hospitals in North America. Overall, 3915 children (52.5% female, 75.5% white, median age 3.8 years) with HUS were included in the study. The median age of patients with ANMs was 3.3 years. In addition to increased mortality in patients with ANMs, average length of stay was also longer in those with ANMs compared to those without (27.8 vs. 13.8 days, p<0.001). The three most common ANMs were encephalopathy (60% of all patients with ANMs), seizures (26.4%), and stroke (22.5%). Mortality varied between specific ANMs encephalopathy (4.3%), seizures (8.9%), meningitis (21.7%), stroke (22.2%), intracranial hemorrhage (40%), cerebral edema (25%), and anoxic brain injury (40%). Patients < 30 days old were at increased risk of mortality, as were those who required mechanical ventilation or ECMO. ANMs independently associated with mortality were brain infarction (OR 2.64, p=0.03), brain hemorrhage (OR 3.09, p=0.005), anoxic brain injury (OR 3.92, p=0.006), and brain edema (OR 4.81, p=0.002).

Image: PD

2020 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

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Acute neurologic manifestations in children with hemolytic uremic syndrome linked to increased mortality - 2 Minute Medicine

Xenon Pharmaceuticals Provides Updates on Proprietary Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2021) -…

BURNABY, British Columbia, Dec. 03, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced that it will provide updates on its proprietary, neurology programs at the Annual Meeting of the American Epilepsy Society (AES 2021).

Mr. Ian Mortimer, Xenons President and Chief Executive Officer stated, We continue to advance our portfolio of neurology-focused programs, and we have a number of scientific presentations scheduled at the AES 2021 meeting in Chicago. In addition, this year we are hosting a symposium focused on our XEN1101 program and the X-TOLE clinical trial results. We are also participating in a joint industry scientific exhibit related to rare genetically-defined epilepsies, with a particular focus on XEN496. We are grateful for the opportunity to meet with leading epileptologists, patient advocacy groups, and other key opinion leaders at this important meeting.

The following summarizes Xenons presentations at AES 2021 related to its proprietary, clinical stage programs as well as promising pre-clinical work:

Poster: Phase 2b Efficacy and Safety of XEN1101, a Novel Potassium Channel Modulator, in Adults with Focal Epilepsy (X-TOLE)

Poster: Electronic Seizure Diary Compliance in an Adult Focal Epilepsy Clinical Trial

Poster: XEN1101, a Differentiated Kv7 Potassium Channel Modulator, Impacts Depression and Anhedonia

Poster: Pathogenic and Likely Pathogenic Variants in KCNQ2 Underlie a Large Majority of Genetic Epilepsy in Neonates and Infants <6 Months of Age

Poster: Nav1.1 Selective Potentiators Normalize Inhibition/Excitation Imbalance and Prevent Seizures in a Mouse Model of Dravet Syndrome

On Sunday, December 5, 2021, Xenon is participating in a joint industry scientific exhibit related to rare genetically-defined epilepsies, and is presenting the following posters:

Conference Call InformationXenon will host a conference call and live webcast today at 9:00 am Eastern Time (6:00 am Pacific Time) to discuss the X-TOLE results presented at AES 2021. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8639677.

About Xenon Pharmaceuticals Inc.

We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit http://www.xenon-pharma.com.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, and other proprietary products; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101 and other proprietary product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, and other proprietary products; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in XEN496, XEN1101, and other proprietary development programs; the timing and results of our interactions with regulators; anticipated enrollment in our clinical trials and the timing thereof; and the progress and potential of our other ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; any of our or our collaborators product candidates, including XEN1101 and XEN496, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Xenon and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

Media/Investors Contact:Jodi RegtsXenon Pharmaceuticals Inc.Phone: 604.484.3353Email: investors@xenon-pharma.com

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American Academy of Neurology (AAN 2022) Braintale Showcases Together with Minoryx Data From Its Biomarker Platform for Disease and Treatment…

STRASBOURG, France--(BUSINESS WIRE)--Braintale, a medtech that is deciphering white matter, spin off from the Assistance Publique-Hpitaux de Paris, showcases, with Minoryx, a biotechnology company developing a treatment for X-linked Adrenoleukodystrophy (X-ALD), the results of the multicentric ADVANCE sub study with Braintale biomarker platform on the occasion of the American Academy of Neurology (AAN). The data were presented digitally on April 24th, 2022. This has also been the occasion to deepen the collaboration between the two companies.

Long underestimated in neurosciences, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Accordingly, Braintale has been developing, since its inception in 2018, non-invasive, accessible, effective and clinically validated measurement and prediction tools for physicians treating patients suffering from brain diseases.

The Braintale platform includes AI-processed CE-marked digital solutions, deployed across three modules. Brainquant enables white matter quantification, brainScore powers clinical prediction and MyelinDex, monitors myelin integrity. Beyond demyelinating conditions, the platform has also been successfully implemented to monitor patients with amyotrophic lateral sclerosis (ALS) and predict recovery for comatose patients after cardiac arrest or trauma brain injury.

X-ALD is an inherited orphan neurodegenerative disease. The most common form is adrenomyeloneuropathy (AMN), which is a highly debilitating chronic disease affecting male and female X-ALD patients reaching adulthood. There is currently no approved treatment for AMN patients. X-ALD male patients can also develop the acute cerebral form, cALD, in both pediatric age and adulthood. cALD results in aggressive brain inflammation leading to permanent disability and death within 2-4 years.

Leriglitazone, a novel brain penetrant PPAR gamma agonist, recently showed significant clinical benefit in Minoryxs ADVANCE Phase II/III clinical trial in adult male patients with AMN. A separate phase II/III study in male pediatric patients with early stage cALD is ongoing (NEXUS).

On the occasion of the American Academy of Neurology, Braintale and Minoryx jointly presented additional results of a multicenter sub-study from the ADVANCE trial. The abstract is available online: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-002872.html

Beyond the characterization of MyelinDex as a relevant biomarker for monitoring disease progression and therapeutic efficacy, these data further support the efficacy of leriglitazone and its potential to improve myelin integrity in the brain of patients affected by AMN. These results pave the way to use of MyelinDex for disease and treatment monitoring in clinical trials as well as patient management in a hospital setting.

The collaboration between the two companies has expanded in order, notably, to implement the use of MyelinDex in additional clinical trials to further characterize beneficial impact of leriglitazone on myelin content, while contributing to a better understanding of X-ALD.

We are very excited to see the potential of Braintales technology to deliver precise and longitudinal analysis of white matter said Marc Martinell, CEO of Minoryx Therapeutics. These results are aligned with preclinical data showing the impact of leriglitazone on myelination.

Pleased with the success of our collaboration to date, Minoryx and Braintale teams have decided to extend their partnership exploring the use of biomarkers developed with the Braintale platforms. Now, together, we are contributing to better understand and improve follow-up, treatment, and stratification of patients with this devastating orphan disease, explains Julie Rachline, co-founder and CEO of Braintale through LallianSe.

About Braintale

Braintale is an innovative medtech company deciphering white matter to enable better care in neurology and intensive care with clinically validated prognostic solutions. With noninvasive, sensitive and reliable measurements of white matter microstructure alterations, Braintale offers a digital biomarkers platform to support clinical decision-making. Braintale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseases. Based on more than 15 years of research and development, Braintale's products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients.

Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR).

For more information, please visit http://www.braintale.eu

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American Academy of Neurology (AAN 2022) Braintale Showcases Together with Minoryx Data From Its Biomarker Platform for Disease and Treatment...

This Neuromuscular Specialist Keeps Life Humming with… : Neurology Today – LWW Journals

Article In Brief

When neuromuscular specialist Zach London, MD, FAAN, is not at work, he engages in other passions like music and game board development. Here he talks about what drives these interests and why he has pursued them since his busiest days as intern in medical school.

In his professional endeavors and personal life, Zach London, MD, FAAN, relishes the opportunity to be creative. Dr. London's innovative nature has come in handy as professor and director of the neurology residency program at the University of Michigan Medical School in Ann Arborthe same institution where he completed his training and a fellowship in clinical neurophysiology.

Among the interactive educational tools he has designed is a web-based training simulator called EMG Whiz. And his efforts were instrumental in developing two mobile applicationsNerve Whiz and Neuro Localizerto teach neuroanatomic localization.

For Dr. London, the goal is to engage learners any way he can, no matter how boring or challenging the subject may be. He credits his former neuroanatomy professor John K. Harting, PhD, at the University of Wisconsin School of Medicine and Public Health in Madison with instilling this belief in him.

With textbooks, workbooks, educational handouts, flash cards, and whatever else he could devise, he would teach the same material in 20 different ways, Dr. London recalled. All that mattered was that at least one of those ways clicked with his students. That was really inspirational to me.

A neuromuscular specialist, Dr. London has published online learning modules for the AAN and other national organizations. He also has received many teaching awards, including the the Consortium of Neurology Program Directors Recognition Award in 2014, the American Neurological Association's Distinguished Teacher Award in 2017, and the American Association of Neuromuscular and Electrodiagnostic Medicine Innovation Award in 2020.

The AAN recently tapped his expertise to promote an upcoming conference in a novel way. He posted this recording on Twitter.

Neurology Today spoke with Dr. London about his musical hobby as well as his interest in developing board games. One of those inventions is The Lesion: Charcot's Tournament, a tabletop strategy board game about neuroanatomy that he co-designed and published.

I was 14 years old when I first started playing. I took one or two lessons and hated it, so I put it down for a few years. Then, when I was a senior in high school, I read a modern translation of Beowulf, and for some reason, I got in my head that I was going to write a rock opera about Beowulf for my English class. I enjoyed that so much that it got me hooked on songwriting and recording. I've never really been a performer. I like the recording process more than anything else.

It's a great instrument for people who are learning to play music. The reason it's so popular is that it's easy to become good enough to play a few songs. It's also portable. You can pick it up and take it with you.

I have a few guitars hanging up on the wall. I have five guitars, a ukulele, a banjo, a mandolin, a bass guitar, and an Irish bouzouki.

I play a little piano, bass, mandolin, and accordion at the novice to intermediate level. I like to pick up new instruments and play them well enough that I can record something once.

The real turning point was when I was an intern. Your life suddenly becomes very busy. A lot of people lose their hobbies when they get into residency. It was a now-or-never moment. I decided I'm either going to stick with it or dedicate myself only to my career. It was really important for my mental health to have a creative outlet.

I record exactly one song per month and post it online at http://www.hardtaco.org. That's a realistic goal for the rest of my life. Having this self-imposed deadline has helped me focus. Some of the songs are throwaways, and some of them are ones I'm proud of. The fact that I stuck with that schedule is something I'm most proud of.

They're mostly simple pop, rock, folk, hip hop, and electronica. I don't have a classical music background. I know some music theory, but I'm not good enough to compose classical or jazz. They're the kind of songs you could hum in your head and put music to. I try to experiment with different genres, so they don't all sound the same. If there's a common thread, half of the songs tend to be silly or clever. I'm always thinking about rhyming words while I'm in the shower or I'm in the car.

My wife, Lauren London, is a trained singer with a musical theater background. She probably is on 75 percent of the songs as a lead or background singer. Professionally, she is a lawyer and the general counsel for Eastern Michigan University, while serving as executive director of a local professional theater company in Ann Arbor.

Our kidsScarlett, 16, and Malcolm, 13occasionally do vocals on the songs. Sometimes I'll write songs that have different characters in them. A few years ago, we did a song about a court trial for a bee who had murdered an elephant. One of the kids played the judge and one played the attorney. They rapped about what happened to this particular elephant.

I've been a board game player my whole life. I got into the modern board game in the mid- or late 1990s, and since then, I've been into trying out new games, especially complex ones. There's definitely a market for more complex games. Board game sales have skyrocketed in the last 20 years.

As a family, we have been involved in making games. We are also board game reviewers. When the pandemic started last year and we were all on lockdown, we decided as a family project we would play one new board game a day. We bought some and borrowed others from friends who are board game enthusiasts. Michigan's stay-at-home order was in place. We called it the Play-At-Home Order [www.theplayathomeorder.com]. The kids and my wife and I would write reviews. By now, we have reviewed up to about 130 games. Some are ones you can play in 10 minutes. It has been a wonderful family activity. Since the kids are back in school, it's harder to convince them to play a new game.

One is a board game called The Lesion: Charcot's Tournament, named after Jean-Martin Charcot, the French physician often considered to be the father of modern neurology. I developed it about five years ago with a colleague, Jim Burke, MD, MS, associate professor of neurology, who is also a board game fanatic. It's essentially based on the concept of neurologic localization on a map of the central nervous system. With any neurologic symptom in the bodysuch as weakness in the arm or facea pathway is interrupted somewhere between the brain and peripheral nerve.

The game's strategy involves looking at a bunch of symptoms and finding where those pathways overlap and where the most likely source of the problem is, where the lesion is.

There's also a non-neurological game we just published that was invented by my son. It's called Battle Thunder Worm (three words in the game), and it's a family-friendly party game. [For more information about the game, visit http://www.battlethunderworm.com.] Players have to put together a combination of two random words to name an invention that would solve a specific problem. And then they have to do a sales pitch as to why their invention is better than everyone else's.

Another game in the works is a card game about the brachial plexus called The Plexus. I'm just putting the final touches on the graphics.

We've sold over 1,000 copies of the Lesion, which has been out for five years. I use a print-on-demand board company called The Game Crafter. People order it through their website. I posted about it on Twitter a couple of months ago, and we sold over 50 copies in a few days. A bunch of neurologists and medical students were interested. It's definitely a target market for sure, very niche. I haven't made any profit. I'm not much of a businessman. I think of this as more of a fun academic project.

At my house every year for the last 25 years, we have done the fortress party. We convert our entire house into a giant maze of sheets. You can't see the walls or the ceiling of the house because everything is covered with sheets. It's a private event and not a good pandemic party.

You have to make time. That's kind of that crossroad I was at as an intern. It's really easy to let things go that are important to you when you're busy. I don't watch as much TV as I used to. I don't read as many books as I would like to. It's important to me and my family to support it, and they've been really wonderful in helping.

Definitely. It helps keep me centered. When I finish writing a song, I record it and I upload it to the website. It's a real sense of accomplishment. In academic medicine, it's good to have several irons in the fire in life, so when one of them isn't succeeding, maybe another one is. Usually, something is going well. Whether it's a work project or a home project, it keeps me engaged and helps me through the stuff that's harder.

Making board games about neurology is fun for me, but I'm also doing it as career development tool. I have to learn the material well, which probably makes me a better doctor. It's an academic niche for me. Some people do research on Alzheimer's. It's totally at opposite ends of the spectrum of what you can do as an academic neurologist.

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Saving patients an unnecessary procedure – EurekAlert

A new study from The Neuro (Montreal Neurological Institute-Hospital) and eight collaborating international epilepsy centers has developed a simple web-based application clinicians can use to predict which patients will not benefit from an invasive diagnostic work-up, preventing unnecessary, invasive procedures, saving time for patients and the clinical team, and freeing up overburdened health resources.

Surgery is the only option to cure seizures inpatients with drug-resistant epilepsy. In evaluating patients for surgery, clinicians have to pinpoint what brain region the seizures are coming from. The way to do this in patients with more complex epilepsy is through stereo-electroencephalography (SEEG), a technique by which a surgeon implants electrodes into the brain to find the source of the seizures.

SEEG is an invasive procedure that requires a one-to-two-week hospital stay and comes with risk of infection, bleeding and stroke in 0.5-2 per cent of procedures. Furthermore, in up to 42 per cent of case series, SEEG does not result in an epilepsy surgical intervention as no focal epileptic focus can be identified. To reduce the amount of people undergoing an unnecessary SEEG, researchers studied epilepsy patients to determine if a series of non-invasive tests could predict which patients would not benefit from SEEG.

The team followed 128 patients at The Neuro who had SEEG, analyzing their demographic, clinical, electroencephalography, neuroimaging, and neuropsychological data. They developed a regression model based on different modalities, called the 5-SENSE-score, that differentiated patients whose SEEG identified a defined seizure source from those that did not. They then validated this score on a larger cohort of 207 patients from nine different tertiary epilepsy centres, finding that it reliably predicted the patients in whom SEEG was unable to identify a focal seizure onset zone.

Many epilepsy centres face the challenging decision of whether a patient should undergo implantation for identifying a focal-seizure onset zone, says Dr. Birgit Frauscher, neurologist at The Neuro and the studys senior author. The 5-SENSE-score provides an easily applicable tool to guide clinicians in predicting patients where SEEG is unlikely to identify a focal seizure onset zone. Patients unlikely to benefit from this invasive and resource-intensive procedure can then be identified earlier, avoiding unnecessary burden on patients and overutilization of hospital resources.

This study, published in the Journal of the American Medical Association on Dec. 6, 2021, was funded by the Montreal Neurological Institute, the Fonds de Recherche du Qubec Sant, and the Austrian Chapter of the International League against Epilepsy.

The Neuro

The Neuro The Montreal Neurological Institute-Hospital is a bilingual, world-leading destination for brain research and advanced patient care. Since its founding in 1934 by renowned neurosurgeon Dr. Wilder Penfield, The Neuro has grown to be the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. The seamless integration of research, patient care, and training of the worlds top minds make The Neuro uniquely positioned to have a significant impact on the understanding and treatment of nervous system disorders. In 2016, The Neuro became the first institute in the world to fully embrace the Open Science philosophy, creating the Tanenbaum Open Science Institute. The Montreal Neurological Institute is a McGill University research and teaching institute. The Montreal Neurological Hospital is part of the Neuroscience Mission of the McGill University Health Centre. For more information, please visitwww.theneuro.ca

Data/statistical analysis

People

Development and Validation of the 5-SENSE Score to Predict Focality of the Seizure-Onset Zone as Assessed by Stereoelectroencephalography

6-Dec-2021

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Saving patients an unnecessary procedure - EurekAlert

Avicanna Files a Patent to Protect its Advanced Oral Cannabinoid Platform and its Applications for Neurological Diseases – Yahoo Finance

Proprietary formulations include a range of liquids, capsules, powders, and controlled release tablets utilizing Avicannas self-emulsifying drug delivery systems (SEDDS) technology

The advanced formulations offer enhanced stability, bioavailability and controlled release of cannabinoids including (CBD, THC, CBG, CBN and THCv)

Avicanna intends to utilize the technology in its medical and pharmaceutical products and develop these formulations for treatment of neurological diseases and disorders

TORONTO, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Avicanna Inc. (Avicanna or the Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based pharmaceuticals is pleased to announce that it has filed a provisional patent application in the United States Patent and Trademark Office for a novel oral cannabinoid technology (the Formulation Candidates), which is intended to be commercialized globally for medical and pharmaceutical applications including treatment of various neurological diseases and disorders.

Oral administration of cannabinoids is the most convenient route for non-invasive drug delivery. However, due to the highly lipophilic nature and poor water-solubility of cannabinoids the elementary formulations currently available on the market generally have poor bioavailability and lack consistent drug delivery. Avicannas proprietary compositions have been specifically designed to alter the hydrophobic nature of cannabinoids, resulting in enhanced drug solubility which leads to better absorption and bioavailability either sublingually or orally, thereby increasing efficacy of cannabinoids.

Our novel formulations overcome the current limitations of cannabinoid finished products in the market today and offer enhanced absorption of varying cannabinoid profiles with controlled delivery. We expect this will yield better patient outcomes and clinical results, stated Dr. Frantz Le Devedec, Executive Vice President of Research and Product Development at Avicanna.

Story continues

The patent application entitled "Oral cannabinoid compositions and methods of treating neurological diseases and disorders" claims formulations that have been developed through Avicanna's R&D platform utilizing the companys proprietary self-emulsifying drug delivery systems (SEDDS) technology and include a range of drug delivery formats with varying release and absorption profiles including:

Sustained and controlled release tablets designed for linear release of the drug over time and thereby maximizing pharmacological properties and reducing side effects particular to cannabinoids.

Oral capsules c self-emulsifying cannabinoid technology designed to enhance absorption through a fast and effective dispersion mechanism.

Sublingual tablets designed to provide rapid absorption of cannabinoids through the sublingual membrane to reduce first pass metabolism and provide a solution for acute symptom management and

Water-soluble formulations nano-emulsion technology designed for instant dispersion and dissolution of cannabinoids which can be utilized for convenient titration in drug delivery and beverages.

This patent submission is another example of our drug delivery platforms used to develop industry leading products as we continue to innovate and lead the path with advanced, standardized and evidenced based cannabinoid solutions. We are optimistic about the potential of these formulations across several of our commercial and clinical platforms globally, stated Aras Azadian, Chief Executive Officer of Avicanna.

Avicanna intends to conduct further pre-clinical studies in the coming months in order to formalize this provisional application and will incorporate the technology into its clinical pipeline in 2022. If granted, this patent application will provide Avicanna with protection on the use of the Formulation Candidates for neurological diseases, alone or in combination with other therapies.

About Avicanna

Avicanna is a Canadian commercial-stage biopharmaceutical company established in cannabinoid research, development, and evidence-based products for the global consumer, as well as medical and pharmaceutical market segments. In leading global cannabinoid advancements, Avicanna conducts most of its research in Canada at its R&D headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto, located in the MaRS Discovery District. The company actively collaborates with leading Canadian academic and medical institutions. Avicanna has established an industry-leading scientific platform including advanced R&D and clinical development which has led to the commercialization of over twenty products across four main market segments:

Medical Cannabis & Wellness Products: Marketed under the RHO Phyto brand, or Magisterial Preparations, these medical and wellness products are an advanced line of pharmaceutical-grade cannabis products containing varying ratios of cannabidiol (CBD) and tetrahydrocannabinol (THC). The product portfolio contains a full formulary of products including oral, sublingual, topical, and transdermal deliveries that have controlled dosing, enhanced absorption and stability studies supported by pre-clinical data. The advanced formulary is marketed with consumer, patient and medical community education and training. Avicannas medical and wellness product portfolio also forms the foundation of the Companys pharmaceutical pipeline with the contribution of the formulations that form the basis of the products as well as the data generated from sales and participation of the products in real world evidence studies.

CBD Derma-Cosmetic Products: Marketed under the Pura H&W or Pura Earth brands, these registered, clinically tested, derma-cosmetic products include a portfolio of functional CBD topical products.

Pharmaceutical Pipeline: Leveraging Avicannas scientific platform, vertical integration, and real-world evidence, Avicanna has created a pipeline of patent-pending drug candidates which are indication-specific and in various stages of clinical development and commercialization. These cannabinoid-based drug candidates provide solutions for unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicannas first pharmaceutical preparation (Trunerox) is in the drug registration stage in South America.

Cannabis Raw Materials, Seeds, and Bulk Formulations: Marketed under the Aureus brand, the Companys raw material business has successfully completed sales to 11 countries. Aureus offers cannabis dried flower, standardized seeds, full spectrum extracts, and cannabinoid distillates, isolated cannabinoids (CBD, THC, cannabigerol (CBG) and other rare cannabinoids), and bulk formulations derived from hemp and cannabis cultivars through its sustainable, economical, and industrial-scale subsidiaries based in Colombia. The majority of the Aureus products are produced at Santa Marta Golden Hemp S.A.S. (SMGH), the Companys majority-owned subsidiary, which is also Good Agricultural and Collection Practices (GACP) certified and has United States Department of Agriculture (USDA) National Organic Program certification for its hemp cultivar.

SOURCE Avicanna Inc.

Stay Connected

For more information about Avicanna, visit http://www.avicanna.com, contact Ivana Maric by email at info@avicanna.com or follow us on social media on Linkedin, Twitter, Facebook or Instagram.

The Company posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCFXPBGdKSxOUOf_VZoSFSUA.

Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains "forward-looking information" within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, "may", "would", "could", "will", "likely", "expect", "anticipate", "believe", "intend", "plan", "forecast", "project", "estimate", "outlook" and other similar expressions and includes statements with respect to the Companys ability to generate data to support a final patent application, the Companys ability to conduct further research on the Formulation Candidate, the grant of any patent for the Formulation Candidate. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management's experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, the availability of licenses, approvals and permits, and the utility and application of certain drugs and products. Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company's annual information form dated September 3, 2021 and final short form prospectus dated November 27, 2020, filed with the Canadian securities regulators and available under the Company's profile on SEDAR at http://www.sedar.com. The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

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Avicanna Files a Patent to Protect its Advanced Oral Cannabinoid Platform and its Applications for Neurological Diseases - Yahoo Finance

Kamel Ben-Othmane, MD, a Neurologist and Headache Medicine Specialist with Riverside Neurology Specialists – Pro News Report

Get to know Neurologist and Headache Medicine Specialist, Dr. Kamel Ben-Othmane, who serves patients in Virginia.

(ProNewsReport Editorial):- New York City, New York Nov 6, 2021 (Issuewire.com)Dr. Ben-Othmane is a board-certified neurologist and headache medicine specialist practicing at Riverside Neurology Specialists Newport News in Newport News, Virginia. He can additionally be found at the Riverside Neurology & Sleep Specialists Gloucester in Gloucester, Virginia, and Riverside Neurology Specialists Hampton in Hampton, Virginia. With a keen interest in all facets of neurology, Dr. Ben-Othmane specializes in headache medicine and maintains a deep understanding of the profound impact of headache disorders, including migraines, on his patients life.

Born and raised in Tunisia, Dr. Ben-Othmane attended the Medical School of Tunis/ Facult de Mdecine de Tunis in Tunis, Tunisia, and graduated with a medical degree in 1990. Nearly a decade later, he relocated to the United States, where he completed an internship at Virginia Commonwealth University Health System (1999 1999) and neurology residency at the Institute of Neurology and the Medical College of Virginia in Richmond, Virginia (1999 2002)

Upon the completion of his training, Dr. Ben-Othmane obtained board certification in neurology from the American Board of Psychiatry and Neurology (ABPN). The ABPN is a not-for-profit corporation that was founded in 1934 as a method of identifying qualified specialists in psychiatry and neurology. Furthermore, he is board-certified in headache medicine by the United Council of Neurologic Subspecialties (2004), as well as in CT and MRI through the American Society of Neuroimaging (2008).

Neurology is a branch of medicine dealing with disorders of the nervous system. Neurology deals with the diagnosis and treatment of all categories of conditions and diseases involving the central and peripheral nervous systems, including their coverings, blood vessels, and all effector tissue, such as muscle.

Dr. Ben-Othmane is licensed to practice medicine in the state of Virginia. A member of the American Academy of Neurology and the American Headache Society, Dr. Ben-Othmane has been named a Top Doctor in Hampton Roads Magazine on multiple occasions.

Outside his professional commitments, Dr. Ben-Othmane enjoys spending time with his wife, living near the coast in Virginia, running, and traveling.

Learn more about Dr. Kamel Ben-Othmane:Through his findatopdoc profile, https://www.findatopdoc.com/doctor/2242516-Kamel-Ben-Othmane-Neurologist, or through Riverside Neurology Specialists, https://www.riversideonline.com/find-a-doctor/find-a-doctor-results/kamel-ben-othmane

About FindaTopDoc.comFindaTopDoc is a digital health information company that helps connect patients with local physicians and specialists who accept your insurance. Our goal is to help guide you on your journey towards optimal health by providing you with the know-how to make informed decisions for you and your family.

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Kamel Ben-Othmane, MD, a Neurologist and Headache Medicine Specialist with Riverside Neurology Specialists - Pro News Report

Study Finds Endovascular Thrombectomy Safe and Effective in… : Neurology Today – LWW Journals

Article In Brief

An analysis of data from the National Inpatient Sample on pregnant and postpartum patients with acute ischemic stroke treated with mechanical thrombectomy suggests that endovascular therapy is a safe and efficacious treatment option for pregnant and postpartum people.

Endovascular mechanical thrombectomy (MT), an interventional procedure that removes a large blood clot from an artery or vein, is safe and effective for acute ischemic stroke (AIS) in pregnant and postpartum patients, according to a large population-based analysis published online first in the September 20 issue of Stroke.

After a series of landmark trials published in the New England Journal of Medicine in 2015, endovascular therapy has become a standard of treatment for AIS. However, it has not been evaluated in pregnant and postpartum patients, a group that is at increased risk but often excluded from clinical trials of interventional therapies.

Historically, pregnant patients are systemically excluded from clinical trials, so we felt it was important to report on this important subgroup of AIS patients. In prospective randomized controlled trials, MT has shown strong efficacy for the treatment of AIS with a number needed to treat of 2.6 for improved outcomes, senior study author Fawaz Al-Mufti, MD, associate chair of neurology for research and associate professor of neurology, neurosurgery, and radiology at New York Medical College, told Neurology Today.

Using data from the National Inpatient Sample, a database from the Healthcare Cost and Utilization Project, from 2012 to 2018, the authors analyzed data on pregnant and postpartum patients with AIS treated with MT. They compared them with nonpregnant patients treated with MT, and subsequently with pregnant and postpartum patients who were managed medically.

Compared to nonpregnant AIS patients treated with MT, pregnant patients experienced lower rates of intracranial hemorrhage and lower rate of poor functional outcome at discharge, Dr. Al-Mufti said. Our findings suggest that endovascular therapy is a safe and efficacious treatment option for pregnant and postpartum woman with AIS who are eligible. We hope providers as well as patients and their families can look to large database analyses such as our study to have the confidence to pursue this life-saving and deficit-preventing procedure should it otherwise be indicated.

The paper looked at 52,825 women hospitalized for AIS over a seven-year period, 4,590 of whom were pregnant or postpartum (defined as up to six weeks following childbirth). In this group, 180 women were treated with MT; these women tended to be younger (33 versus 71 mean years, p<0.001) and were more likely to present with extreme acute illness severity compared with the group of 48,055 nonpregnant patients treated with MT.

The study's primary clinical endpoints were functional outcome, all-cause in-hospital mortality, and hospital length of stay. Secondary endpoints included neurological complications specifically relevant to MT treatment for AIS, mainly intracranial hemorrhage and subsequent decompressive hemicraniectomy.

Patients treated with MT had lower rates of both intracranial hemorrhage (11 percent vs 24 percent, p=0.069) and poor functional outcome (50 percent vs 72 percent, p=0.003) at discharge. After adjusting for age, illness severity, and stroke severity, women who were pregnant or postpartum still showed an independently associated lower likelihood of developing intracranial hemorrhage (adjusted odds ratio, 0.26 [95% CI, 0.09-0.70]; p=0.008).

The authors also evaluated complications and outcomes between pregnant and postpartum patients treated with MT and those who were medically managed (4,410 patients). Using propensity score matching, the researchers reported pregnant and postpartum patients treated with thrombectomy had an increased rate (17 percent) of venous thromboembolism compared with medically managed pregnant and postpartum patients (0 percent; p=0.001) but a lower rate of pregnancy-related complications (44 percent vs 64 percent, p=0.034).They found no significant difference in postpartum complications, functional outcome at discharge, or hospital length of stay in these patient groups. No patients in the MT group experienced miscarriage after the procedure.

A major strength of the study, Dr. Al-Mufti said, was the large sample size using national data and, particularly, the number of pregnant and postpartum patients who had undergone MT. Although the retrospective nature of our finding is a limitation of the study that would normally warrant prospective validation, given the rarity of ischemic stroke during pregnancy and the postpartum period, prospective trials evaluating the usage of MT would be challenging.

As a result, he said, large-scale, multicenter investigations such as the present analysis offer meaningful insight into the utilization of these treatment modalities.

Vascular neurologists and neurocritical care experts told Neurology Today that this study was an important contribution to an area of stroke care that is insufficiently studied.

The current guidelines from the American Heart Association recommend consideration of these types of therapies including thrombolysis and endovascular MT during pregnancy if a person has disabling deficits and the benefits outweigh bleeding risks, but they make a slightly equivocal recommendation that it is reasonable to do it and don't really make recommendations about the postpartum period, said Eliza C. Miller, MD, assistant professor of neurology in the division of stroke and cerebrovascular disease at Columbia University Medical Center, who focuses on women's cerebrovascular health and cerebrovascular complications of pregnancy and the postpartum period.

This is mainly because there's really been a lack of data because pregnant and postpartum people have been excluded from all of the prospective trials that have looked at the safety and efficacy of these types of hyperacute stroke therapies.

The current paper presents the largest cohort reported to date of pregnant patients with AIS treated with MT, said Christa O'Hana S. Nobleza, MD, MSCI, medical director of the neurocritical care service at Baptist Memorial Hospital and associate professor in the department of neurology at the University of Tennessee Health Science Center in Memphis.

Before this study, there were only case reports or case series reporting on interventional acute stroke therapy for the pregnant. This study evaluated important factors that possibly limited pregnant patients from undergoing MT, such as potential for hemorrhage and worsening outcomes, and showed that those who underwent thrombectomy did not have higher rates of intracranial hemorrhage or worsened outcomes.

The data found an increased use of thrombectomy since the 2015 thrombectomy clinical trials and also showed that the outcomes from thrombectomy in pregnant women versus thrombectomy in nonpregnant women were similar or betterprobably because of the age difference in these two groups, Victor C. Urrutia, MD, FAHA, associate professor of neurology and director of the Comprehensive Stroke Center at the Johns Hopkins Hospital, said. In addition to the increase in thrombectomy, it shows there's a been a decrease in hemicraniectomy, suggesting that perhaps the benefit of thrombectomy, which is mainly decreasing the size of the stroke, has prevented the need of treatments of large stroke-producing edema in the form of hemicraniectomy.

One key takeaway is the group of women treated with MT didn't have pregnancy-related complications or increased mortalityso all of these things that people worry about did not occur, Dr. Miller said. Another interesting finding, she added, was that pregnant and postpartum patients who had MT were more likely to have venous thromboembolism. This could be explained by the fact that those who get MT are people who had a very large stroke, so you're possibly comparing them with people who had a more minor stroke and might be able to get up and walk more easily, she noted. But it is important for us to remember in general that pregnancy and the postpartum state increase the risk of venous thromboembolism very significantly, so just like with all our stroke patients, we must be hypervigilant about preventing this complication.

Overall, this paper establishes more conclusively that endovascular thrombectomy for acute stroke should be made available for pregnant women who meet the criteria, Dr. Urrutia said. I think the paper might change practice in the sense that those who may have been hesitant for lack of data to consider patients who were pregnant and who were having stroke for treatment might more easily consider it.

Dr. Miller agreed. Yes, there can be a discussion of risk, but I would say in the vast majority of cases, the benefits are going to be so much greater than the risks. I hope that this study helps reassure people that it's okay to offer this therapy that's so life- and function-saving.

The limitation of the analysis, as the study authors and all of the commentators pointed out, is its use of an administrative dataset, which does not allow for more nuanced information about the patients or their long-term outcomes beyond hospital discharge.

Still, Dr. Nobleza said she believes this study provides an important foundation for future potential studies analyzing the effect of acute stroke reperfusion therapies on pregnant patients. Study designs that can incorporate the pregnant patient are needed; however, they are challenging. For now, I believe the information from this study can still be utilized to guide shared decision making regarding acute stroke reperfusion therapy for the pregnant population.

Dr. Urrutia said he would also like to see more specific outcome data in future studies, for example, using measures like the modified Rankin score. I doubt that there would be a randomized clinical trial to test this, so I think the future is probably going to be more pooled individual patient data meta-analyses and those types of studies. With a relatively low frequency eventpregnancy-associated stroke treated with thrombectomy, the difficulty is to be able to get enough cases to also witness the more granular data.

Dr. Miller, however, suggested that the concept of excluding people who are pregnant or postpartum from clinical trials should be revisited. Stroke is a major cause of maternal mortality in the United Statesand even more a cause of severe maternal morbidityso we should be doing everything we can to prevent death and disability in people who are pregnant or postpartum.

While she acknowledged the challenging nature of designing such clinical trials, she pointed out that she conducts a lot of research in collaboration with obstetrician-gynecologists, who are experts in doing clinical trials in pregnant and postpartum people, including interventional and medication trials. There's a whole network for maternal fetal medicine trials, just like we have StrokeNet in stroke, and they do these trials all the time, so it's certainly feasible to enroll pregnant people in clinical trials.

Dr. Miller said it is frustrating to see people who happen to be pregnant or postpartum are not being treated for acute stroke in the same way they would be treated if they weren't pregnant. For example, I sometimes see or have heard about imaging being delayed because people are worried about the radiation risk and they wait for the MRI or they don't do the CT angiogram, but all of these things have been shown to have minimal risk in pregnancy, and the recommendations from both the American College of Obstetricians and Gynecologists and also the American College of Radiology state that, in the case of a life-threatening condition in the mother, these types of imaging studies should not be delayed or withheld. Obviously stroke with a large vessel occlusion is life-threatening and function-threatening, Dr. Miller said.

We should all remember that pregnant women and women in the early postpartum time, which is generally considered to be 6 weeks, are at higher risk of stroke than women of the same age and profile, and that we should address acute onset of neurologic deficits the same way that we would address any other person and consider the treatments that are appropriate depending on the cause of those deficits, Dr. Urrutia said.

Dr. Urrutia is the PI of a national randomized multisite trial called OPTIMISTmain, which is funded by Genentech. Dr. Miller receives research support from the National Institutes of Health, National Institute of Neurological Disorders and Stroke, and the Louis V. Gerstner, Jr. Foundation.

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Study Finds Endovascular Thrombectomy Safe and Effective in... : Neurology Today - LWW Journals

COVID-19 and Vaccination in the Setting of Neurologic Disease: An Emerging Issue in Neurology – DocWire News

This article was originally published here

Neurology. 2021 Jul 29:10.1212/WNL.0000000000012578. doi: 10.1212/WNL.0000000000012578. Online ahead of print.

ABSTRACT

The COVID-19 pandemic caused by the SARS-CoV-2 virus has left many unanswered questions for patients with neurological disorders and the providers caring for them. Elderly and immunocompromised patients are at increased risk for severe symptoms due to COVID-19, and the virus may increase symptoms of underlying neurological illness, particularly for those with significant bulbar and respiratory weakness or other neurologic disability. Emerging SARS-CoV-2 vaccines offer substantial protection from symptomatic infection, but both patients and providers may have concerns regarding theoretical risks of vaccination, including vaccine safety and efficacy in the context of immunotherapy and the potential for precipitating or exacerbating neurological symptoms. In this statement on behalf of the Quality Committee of the AAN we review the current literature, focusing on COVID-19 infection in adults with neurological disease, in order to elucidate risks and benefits of vaccination in these individuals. Based on existing evidence, neurologists should recommend COVID-19 vaccination to their patients. For those patients being treated with immunotherapies, attention should be paid to timing of vaccination with respect to treatment and the potential for an attenuated immune response.

PMID:34326180 | DOI:10.1212/WNL.0000000000012578

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COVID-19 and Vaccination in the Setting of Neurologic Disease: An Emerging Issue in Neurology - DocWire News

Oyesiku to Receive Distinguished Service Award from Society of University Neurosurgeons | Newsroom – UNC Health and UNC School of Medicine

The award will presented to Dr. Oyesiku at the Societys 2021 Annual Meeting August 8-11.

Nelson M. Oyesiku, MD, PhD, FACS, Chair Chair of the UNC School of Medicine Department of Neurosurgery, will receive the Distinguished Service Award given by the Society of University Neurosurgeons at their 2021 Annual Meeting in Whitefish, Montana, August 8-11.

Prior to joining the UNC faculty on April 1, 2021, Dr. Oyesiku was Professor of Neurological Surgery and Medicine (Endocrinology) at Emory University, Atlanta, Georgia and the Inaugural Daniel Louis Barrow Chair in Neurosurgery, Vice-Chairman of the Department of Neurological Surgery and Director of the Neurosurgical Residency Program. Dr. Oyesikus clinical expertise is pituitary medicine and surgery. Dr. Oyesiku was co-director of the Emory Pituitary Center and has developed one of the largest practices entirely devoted to the care of patients with pituitary tumors in the country and has performed over 3,700 pituitary tumor operations. Dr. Oyesiku obtained his MD from the University of Ibadan, Nigeria. He obtained an MSc in Occupational Medicine from the University of London, UK and completed a PhD in Neuroscience at Emory University. He completed his Surgery Internship at the University of Connecticut-Hartford Hospital and obtained his neurosurgical training at Emory University, Atlanta. He is board-certified by the American Board of Neurological Surgery. He received an NIH K08 Award and Faculty Development Award from the Robert Wood Johnson Foundation was a recipient of an NIH R01 award and PI of the NIH/NINDS R25 Research Education Program for Residents and Fellows in Neurosurgery. Dr. Oyesiku has served on several NIH Study Sections. Dr. Oyesikus research is focused on the molecular pathogenesis of pituitary adenomas, and tumor receptor imaging and targeting for therapy.

Dr. Oyesiku has served on various state, regional, national and international committees for all the major neurosurgical organizations. He has served on the Board of Directors and as Chairman of the American Board of Neurological Surgery. He was on the ACGME-Residency Review Committee of Neurosurgery. He is a Fellow of the American College of Surgeons and has served on its Board of Governors. Dr. Oyesiku has been President of the Congress of Neurological Surgeons. He has served as Secretary/Treasurer and President of the Georgia Neurosurgical Society, President of the Society of University Neurosurgeons, and Vice-President of the American Academy of Neurological Surgeons. He is President of the International Society of Pituitary Surgeons. He is President-Elect of the World Federation of Neurological Surgeons.

Dr. Oyesiku is Editor-in-Chief of NEUROSURGERY, OPERATIVE NEUROSURGERY and NEUROSURGERY OPEN leading journals in neurosurgery. He is author of over 180 scientific articles and book chapters.

He has been selected by his peers as one of The Best Doctors in America and was selected by the Consumer Research Council of America as one of Americas Top Surgeons. He is named in Marquis Whos Who in America. He is a member of the Honor Medical Society Alpha Omega Alpha. He was awarded the Gentle Giant Award by the Pituitary Network Association for his services to Pituitary Surgery and Medicine. He is on the Medical Advisory Board of the Cushings Support and Research Foundation. He has been visiting professor and invited faculty at several departments of neurosurgery in the United States and abroad.

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Oyesiku to Receive Distinguished Service Award from Society of University Neurosurgeons | Newsroom - UNC Health and UNC School of Medicine

electroCore Announces Full Enrollment of TR-VENUS study of Non-Invasive Vagal Nerve Stimulation (nVNS) for the Acute Treatment of Stroke – BioSpace

ROCKAWAY, N.J., Feb. 02, 2021 (GLOBE NEWSWIRE) -- electroCore Inc.(Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that full enrollment has been achieved for the TR-VENUS study of non-invasive vagal nerve stimulation (nVNS) for the acute treatment of stroke. TR-VENUS is a double blind, randomized, sham-controlled, multi-center clinical trial, conducted at nine major medical centers across Turkey, supported by the Turkish Neurological Society and partially funded through an unrestricted research grant from electroCore.

Stroke is the second highest cause of death and the third leading cause of disability globally . Ischemic stroke, caused by arterial occlusion, is the most common type of stroke. The effectiveness of current management strategies (e.g. rapid reperfusion with intravenous thrombolysis and endovascular thrombectomy) is dependent on time to treatment. Treating stroke quickly and safely is imperative for maximizing the therapeutic benefits of therapy. electroCores small and portable nVNS device, gammaCore Sapphire, offers the opportunity for administration rapidly after the onset of stroke. The scientific hypothesis supporting the TR-VENUS study is based, in part, on preclinical evidence from studies conducted in the lab of Ilknur Ay at Massachusetts General Hospital, Harvard Medical School suggesting that vagus nerve stimulation (VNS) results in a protective effect against ischemic brain injury1.

The TR-VENUS study recruited a total of 60 subjects with ischemic stroke and eight subjects with hemorrhagic stroke. The primary objective was to assess the safety of nVNS in the setting of acute stroke by examining decreases in arterial blood pressure, severe bradycardia, progression of neurological deficits and death. Feasibility was also assessed by determining the proportion of allocated stimulation doses that could be administered. Secondary efficacy outcomes evaluated neurologic deficits and infarct growth. Top-line data will be reported once available and full results will be published in a peer reviewed medical journal later this year.

The lead investigators of the study, Professors Ethem Murat Arsava and Mehmet Akif Topcuoglu of the Department of Neurology, Hacettepe University in Ankara, Turkey, commented, We are very pleased to have successfully completed enrollment of this Phase 2 trial to assess the safety and feasibility of nVNS for the acute treatment of stroke. We are hopeful that nVNS might be a viable option to improve the treatment of acute stroke.

We congratulate and thank the investigators, patients and families that all supported the successful completion of study enrollment and we look forward to the data readout and what it tells us about nVNS potential as an acute treatment for stroke, saidEric Liebler, Senior Vice President of Neurology at electroCore.

For complete details on the study design please see clintrials.gov: https://clinicaltrials.gov/ct2/show/NCT03733431?term=NCT03733431&draw=2&rank=1

About gammaCoregammaCore(nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patients neck over the vagus nerve, gammaCore stimulates the nerves afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared inthe United Statesfor adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in theEuropean Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache withinNHSEngland.

In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patients neck, available under an emergency access mechanism called an EUA.

gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patients neck during the Coronavirus Disease 2019 (COVID-19) pandemic.

gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.

gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked.

Further information is available at:

Authorization Letter:https://www.fda.gov/media/139967/download

Fact Sheet for Healthcare Providers:https://www.fda.gov/media/139968/download

Fact Sheet for Patients:https://www.fda.gov/media/139969/download

Instructions for gammaCore usehttps://www.fda.gov/media/139970/download

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The companys current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visitwww.electrocore.com.

Forward-Looking StatementThis press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects, sales and marketing, and product development plans, future cash flow projections, anticipated costs, its pipeline or potential markets for its technologies, the availability and impact of payer coverage, the potential product use for other indications, the results of TR-VENUS study and the potential use of gammaCore for the acute treatment of stroke, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCores business, sales and marketing, and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to successfully commercialize gammaCore, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with theSECavailable atwww.sec.gov.

Investors:Hans VitzthumLifeSci Advisors617-430-7578hans@lifesciadvisors.com

or

Media Contact:Jackie DorskyelectroCore973-290-0097

1 Ay I, Nasser R, Simon B, Ay H. Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Ischemic Injury in Rats. Brain Stimul. 2016 Mar-Apr;9(2):166-73. doi: 10.1016/j.brs.2015.11.008. Epub 2015 Dec 1. PMID: 26723020; PMCID: PMC4789082.

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electroCore Announces Full Enrollment of TR-VENUS study of Non-Invasive Vagal Nerve Stimulation (nVNS) for the Acute Treatment of Stroke - BioSpace

Internet-Based Intervention for Sleep in Adults with Mild Cognitive Impairment – Neurology Advisor

Internet-based intervention that includes daily reminders to complete sleep diaries and wear actiwatch can potentially improve sleep in older adults with mild cognitive impairment (MCI), according to study results published in Alzheimers & Dementia.

Patients with MCI are at increased risk for sleep disturbances, and internet-based interventions may aid in improving sleep in this population. As limited data exist on the role of technology in this population, this study aimed at using an existing internet-delivered cognitive behavioral therapy for insomnia, called Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness (SHUti OASIS). SHUti Oasis collects daily sleep diary data and delivers the automated intervention throughout 9 weeks.

In this ongoing study, researchers collected daily sleep diary data using wrist-worn actigraphs over a 14-day period before the intervention and over a 14-day period after the intervention. SHUTi OASIS sent daily morning emails to remind participants to complete the sleep diary and wear the actiwatch at night.

The study sample included 7 patients (mean age 76.0 years; women, 4) and 4 spouses. All patients with MCI completed 10 sleep diaries over the course of 14 days. Most accessed the SHUTi OASIS program daily and wore the actiwatch between 5 and 14 days.

The automated e-mail reminders and logging into SHUTi OASIS program may be associated with the completion of participants sleep diaries. Inconsistent use of actigraphy at night may be secondary to the early-morning timing of e-mail reminders.

Incorporating technology for subjective and objective sleep data collection in this population is promising, and future work should consider frequency and timing of reminders with multimodal technology use, concluded the study researchers.

Reference

Mattos MK, Barnes L, Davis EM, et al. Preliminary feasibility of technology use in an internet-delivered intervention: Improving sleep in older adults with mild cognitive impairment. Alzheimers Dement. Published online December 7, 2020. doi:10.1002/alz.038831

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Internet-Based Intervention for Sleep in Adults with Mild Cognitive Impairment - Neurology Advisor