Zynerba Pharmaceuticals Announces the Acceptance of Two Posters at the Virtual Joint 49th Annual Child Neurology Society & 16th International…

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DEVON, Pa., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today has announced the acceptance and presentation details of two posters at the virtual Joint 49th Annual Child Neurology Society & 16th International Child Neurology Society Congress (CNS-ICNA) Meeting. The CNS-ICNA annual meeting is being held virtually from October 12th through October 23rd, 2020. A copy of the posters will be made available on the Zynerba corporate website at the time of presentation on Monday October 12th at http://zynerba.com/publications/.

Title: "ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome: Role of Methylation Status as a Correlate to Disease Severity and as a Prognostic Biomarker"Abstract number: 0406 0585 000889Primary keyword: Cognitive/Behavioral Disorders(including Autism) Poster number: 678

Title: "Tolerability and Efficacy of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study [BRIGHT (ZYN2-CL-030)]Abstract number: 0406 0585 000888Primary keyword: Cognitive/Behavioral Disorders(including Autism) Poster number: 677

About Zynerba Pharmaceuticals, Inc. Zynerba Pharmaceuticals is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome, autism spectrum disorder, 22q11.2 deletion syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. Learn more at http://www.zynerba.com and follow us on Twitter at @ZynerbaPharma.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Companys current expectations. These and other risks are described in the Companys periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available atwww.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Zynerba ContactWill Roberts, VP Investor Relations and Corporate Communications484.581.7489robertsw@zynerba.com

Media contactMolly DevlinEvoke KYNE215.928.2199Molly.Devlin@evokegroup.com

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Zynerba Pharmaceuticals Announces the Acceptance of Two Posters at the Virtual Joint 49th Annual Child Neurology Society & 16th International...

The impact of COVID-19 on mental, neurological and substance use services: results of a rapid assessment – World – ReliefWeb

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Executive summary

The World Health Organization (WHO) has identified mental health as an integral component of the COVID-19 response. Its rapid assessment of service delivery for mental, neurological and substance use (MNS) disorders during the COVID-19 pandemic, on which this report is based, is the first attempt to measure the impact of the pandemic on such services at a global level. The data were collected through a web-based survey completed by mental health focal points at ministries of health between June and August 2020. The questionnaire covered the existence and funding of mental health and psychosocial support (MHPSS) plans, the presence and composition of MHPSS coordination platforms, the degree of continuation and causes of disruption of different MNS services, the approaches used to overcome these disruptions, and surveillance mechanisms and research on MNS data.

In total, 130 (67%) WHO Member States, across all WHO regions, submitted answers to the survey. Data were disaggregated by region, income group and stage of transmission of COVID-19.

The vast majority, 116 or 89% of responding countries, reported that MHPSS response is part of their national COVID-19 response plans. However, only 17% of these countries have ensured full additional funding for MHPSS covering all activities.

Two-thirds (65%) of responding countries have a multisectoral MHPSS coordination platform for COVID-19 response, and more than 65% of these countries include the ministries of health, social/family affairs and education and also nongovernmental organizations as part of these platforms.

Almost half (51%) of responding countries reported that ensuring the continuity of all MNS services was included in the list of essential health services in their national COVID-19 response plan, while 40% of countries reported the inclusion of some MNS services in the list of essential health services in their national response plan.

To understand government policies on access to a range of MNS services, the status of closure of existing services was checked across different categories and settings. A total of 10 types of services for MNS disorders were included, such as inpatient and outpatient services at mental hospitals; outpatient services, inpatient psychiatric and neurological units as well as treatment of substance use disorders at general hospitals; and services for MNS disorders at primary health care, residential, home and day care services at community level. No country reported a full closure of all services; but in only 7% of responding countries were all services fully open, with 93% of countries reported disruptions in one or more of their services for MNS disorders.

There were differences in the types of service affected by closure, with outpatient services in mental and general hospitals as well as community-based services predominantly more affected. For example, community-based services were more impacted compared with inpatient facilities, with full or partial closure in more than 40% of countries and home care and day care services reaching levels of full or partial closure in 6070% of countries.

Countries were also asked to report on disruption (complete or partial) of delivery of specific MNS interventions. For the purpose of the survey, complete disruption was defined as more than 50% of users not served as usual, and partial disruption as between 5% and 50% of users not served as usual.One-third (33%) of responding countries reported complete or partial disruption across at least 75% of specific MNS-related interventions/services. This level of disruption was the highest within countries in the community transmission stage of COVID-19 (44%).

An important finding is that some life-saving emergency and essential MNS services were reported as being disrupted; 35% of countries reported some disruption of management of emergency MNS manifestations (including status epilepticus, delirium and severe substance withdrawal syndromes) and 30% reported disruption in supply of medications for people with MNS disorders.

Prevention and promotion mental health services and programmes were most severely affected. Around three-quarters of school mental health or workplace mental health services were wholly or partially disrupted. Approximately only 30% of mental health services for children and adolescents or for older adults were available with no disruption, and fewer than 40% of antenatal or postnatal mental health services were not disrupted. Almost 60% of all psychotherapy and counselling services were reported as partially disrupted. Overdose prevention and management programmes and critical harm reduction services were disrupted in more than 50% of countries.

The main causes of disruption were identified as a decrease in outpatient volume due to patients not presenting, travel restrictions hindering access to health facilities for patients and a decrease in inpatient volume due to cancellation of elective care.

Community-based services and mental health prevention and promotion programmes, already limited in availability, are reported to be disrupted at a time when society needs them the most due to the adverse mental health impacts COVID-19.

Countries have responded to the disruption of MNS services in multiple ways. Some 70% of countries have responded by using telemedicine/teletherapy to replace in-person consultations (this included use of any remote contact, such as telephone or video conferencing). Other measures that were reported include helplines for MHPSS (68%) and specific measures for infection prevention and control in mental health services (65%). Training in basic psychosocial skills for health care providers working in COVID-19 treatment centres was the most common approach in low-income countries (60%). Generally speaking, however, interventions such as task sharing through building the capacity of general health workers seem to be underutilized in many countries (38%).

Slightly more than half of responding countries (53%) were reported to be collecting data on MNS disorders or manifestations in people with COVID-19, and two-thirds (66%) of countries reported ongoing or planned studies related to the impact of COVID-19 on mental health. A gap was identified in the areas of substance use and neurology research related to the pandemic.

This report provides key insights into the extent of disruption of MNS services and measures being adopted in response. Certain limitations should be kept in mind when examining the results of this rapid assessment; these include the limitations associated with self-reported data, particularly concerning judgements often being made by a single focal point.

The survey highlights the need to strengthen the monitoring of changes in service availability, delivery and utilization at country level, and to establish informed decision making on required adaptations and strategies for MNS services during the pandemic. WHO has published Maintaining essential health services: operational guidance for the COVID-19 context (1) which should be considered when making specific adaptations and considerations for safe delivery and restoration of MNS services, including emergency acute care and outpatient care guidance.

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Stem cells can repair Parkinson’s-damaged circuits in mouse brains – University of Wisconsin-Madison

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The mature brain is infamously bad at repairing itself following damage like that caused by trauma or strokes, or from degenerative diseases like Parkinsons. Stem cells, which are endlessly adaptable, have offered the promise of better neural repair. But the brains precisely tuned complexity has stymied the development of clinical treatments.

In a new study addressing these hurdles, University of WisconsinMadison researchers demonstrated a proof-of-concept stem cell treatment in a mouse model of Parkinsons disease. They found that neurons derived from stem cells can integrate well into the correct regions of the brain, connect with native neurons and restore motor functions.

The key is identity. By carefully tracking the fate of transplanted stem cells, the scientists found that the cells identity dopamine-producing cells in the case of Parkinsons defined the connections they made and how they functioned.

Coupled with an increasing array of methods to produce dozens of unique neurons from stem cells, the scientists say this work suggests neural stem cell therapy is a realistic goal. However, much more research is needed to translate findings from mice to people.

Su-Chun Zhang talks with a postdoctoral student in his research lab at the Waismam Center. Photo: Jeff Miller

The team, led by UWMadison neuroscientist Su-Chun Zhang, published its findings Sept. 22 in the journal Cell Stem Cell. The research was led by Zhang lab postdoctoral researchers Yuejun Chen, Man Xiong and Yezheng Tao, who now hold faculty positions in China and Singapore.

Our brain is wired in such an accurate way by very specialized nerve cells in particular locations so we can engage in all our complex behaviors. This all depends on circuits that are wired by specific cell types, says Zhang, a professor of neuroscience and neurology at UWMadisons Waisman Center. Neurological injuries usually affect specific brain regions or specific cell types, disrupting circuits. In order to treat those diseases, we have to restore these circuits.

To repair those circuits in the Parkinsons disease mouse model, the researchers began by coaxing human embryonic stem cells to differentiate into dopamine-producing neurons, the kind of cells that die in Parkinsons. They transplanted these new neurons into the midbrains of mice, the brain region most affected by Parkinsons degeneration.

Several months later, after the new neurons had time to integrate into the brain, the mice showed improved motor skills. Looking closely, Zhangs group was able to see that the transplanted neurons grew long distances to connect to motor-control regions of the brain. The nerve cells also established connections with regulatory regions of the brain that fed into the new neurons and prevented them from being overstimulated.

Both sets of connections feeding in and out of the transplanted neurons resembled the circuitry established by native neurons. This was only true for dopamine-producing cells. Similar experiments with cells producing the neurotransmitter glutamate, which is not involved in Parkinsons disease, did not repair motor circuits, revealing the importance of neuron identity in repairing damage.

To finally confirm that the transplanted neurons had repaired the Parkinsons-damaged circuits, the researchers inserted genetic on-and-off switches into the stem cells. These switches turn the cells activity up or down when they are exposed to specialized designer drugs in the diet or through an injection.

When the stem cells were shut down, the mices motor improvements vanished, suggesting the stem cells were essential for restoring Parkinsons-damaged brains. It also showed that this genetic switch technology could be used to fine-tune the activity of transplanted cells to optimize treatment.

Zhang found that neurons derived from stem cells can connect with native neurons and restore motor functions. But more research is needed to translate the findings from mice to people.

The Zhang group and other researchers have spent years developing methods to turn stem cells into the many different types of neurons within the brain. Each neurological disease or injury would require its own specialized nerve cells to treat, but the treatment plans would likely be broadly similar. We used Parkinsons as a model, but the principle is the same for many different neurological disorders, says Zhang.

The work has personal meaning to Zhang. As a physician and scientist, he often receives letters from families desperate for help treating neurological disorders or brain trauma. Its also an experience he can relate to. Six years ago, Zhang was in a bike accident and broke his neck. When he awoke partially paralyzed in the hospital, his first thought was of how stem cells which he had already researched for years could help him recover.

Now, largely rehabilitated after years of physical therapy, Zhang still believes that the right stem cell treatments could, in the future, help people like him and the families he hears from.

To that end, Zhangs group is currently testing similar treatments in primates, a step toward human trials.

There is hope, but we need to take things one step at a time, he says.

This work was supported in part by the National Institutes of Health (grants NS096282, NS076352, and NS086604, MH099587 and MH100031).

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Neurologic function and COVID-19 | Feeling Fit – yoursun.com

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Q: My family has a history of neurologic disease. My grandfather died from a stroke. An uncle was diagnosed with early-onset Alzheimer's disease at 40, and my brother recently was diagnosed with an aneurysm. I'm wondering if our family is at greater risk for COVID-19? Are there any neurologic symptoms we should be on the lookout for?

A: Being diagnosed with any neurologic disease can be difficult for patients and their families, but it can be even more concerning now. The new coronavirus, SARS-CoV-2, which causes COVID-19, has become a concern for everyone, but it is particularly concerning for older individuals and those with other health issues or decreased immune systems. Neurological disorders are among the underlying medical conditions that may increase the risk of serious COVID-19 complications for individuals of any age.

The neurological effects of COVID-19 are still being studied. What's unknown is whether these are direct effects of the virus entering the nervous system or consequences of the disease's effect on the body. There are bits of information that have come out from a number of studies looking at clinical evaluation of patients that would suggest that there is nervous system direct involvement by the virus, but the reliability of those studies is still in question.

Recent findings are indicating that stroke is one of the conditions that has been seemingly at higher incidence in patients who have involvement in the body by COVID-19. Why the strokes occur in people infected with COVID-19 is yet to be fully determined. It's thought that a lot of it might be worsening of the damaged blood vessels these individuals have, which makes them predisposed to stroke, and then their bodies are being stressed from a respiratory perspective by this intense illness.

Normally, when people are sick, particularly when their respiratory system is failing, we know there will be adverse effects on the brain because of poor oxygenation and other metabolic effects. While these effects are serious, they are not direct effects of the virus on the brain itself.

There have been reports about patients who have experienced COVID-19 and who also had some neurological signs and symptoms, such as change of taste and smell and confusion. The challenge is that there is a lot we do not know about COVID-19, including if these issues are a direct effect of the virus actually getting into the nervous system and damaging the brain, or whether it's an indirect effect as a consequence of the respiratory failure or compromise of other organs of the body. It is important to remember that COVID-19 is not the only virus that causes these symptoms of reduced smell. Influenza is well known to affect taste and smell, too, and there are other respiratory viruses that can cause similar kinds of troubles. COVID-19, however, seems to cause this at a higher frequency. But again, the challenge is whether the virus is actually directly affecting the nerves that have to do with taste and smell, or if it is the respiratory epithelium that is injured, that interacts with the nerve in the back of the nose.

The principle things that we'll see from a neurological viewpoint in relation to COVID-19 will be changes in mental awareness, cognition, troubles with difficulty of interaction or ability to interact with the environment. One of our concerns is how much of this is going to be long lasting and how much of this is just a temporary effect of metabolic disturbances. So, those are very much uncertain points at this time.

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ESCAPE Bio Closes $73 Million in Crossover Financing to Advance Clinical Development of Precision Neurology Medicines for Genetic Neurodegeneration -…

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--ESCAPE Bio, a clinical stage company developing novel, precisely targeted therapeutics for genetic neurodegenerative diseases, today announced the closing of a $73M financing led by Wellington Management Company LLP. Additional new investors include Avidity Partners, CAM Capital, New Leaf Ventures, Rock Springs Capital, Surveyor Capital (a Citadel company) and Sphera Funds Management, who join existing investors OrbiMed, Novo Holdings, Johnson & Johnson Innovation, Novartis Venture Fund, Osage University Partners and Sutter Hill Ventures.

We are delighted to partner with these new outstanding investors as we advance our pipeline of precision neurology medicines, commented Julie Anne Smith, President and Chief Executive Officer of ESCAPE. The proceeds allow us to accelerate two programs into patients who lack disease modifying treatments.

About ESCAPE Bio

ESCAPE Bio is a clinical stage, privately held biopharmaceutical company developing novel, precisely targeted therapeutics for genetically defined neurodegenerative diseases. ESB1609 is in a Phase 1 multiple ascending dose study in healthy volunteers. ESCAPE has advanced a mutant-selective LRRK2 G2019S kinase inhibitor for Parkinsons Disease (PD) patients to IND-enabling studies. A pharmacologic structure corrector of Alzheimer's patients carrying the ApoE4 risk allele is in Discovery. For additional information, please visit http://www.escapebio.com.

About ESB1609

ESB1609 is a novel, orally administered, brain-penetrant and selective sphingosine-1-phosphate 5 (S1P5) receptor agonist. S1P5 receptors are predominantly expressed in the central nervous system (CNS) and natural killer (NK) cells as one of five receptors within the G-protein-coupled S1P receptor family (S1P1 S1P5). Activation of S1P5 plays a significant counteractive role in many aspects of neurodegenerative disease relevant biology inclusive of upregulating several CNS lipid transporters. S1P5 agonism has normalized brain ceramide and sphingosine phosphate levels and promoted clearance of aggregation-prone proteins across multiple pre-clinical models of neurodegeneration. ESB1609 is currently in a Phase 1 randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and biomarker study of escalating multiple doses in healthy volunteers.

About ESB5070

ESB5070 is a novel, orally-administered, brain-penetrant and selective Leucine-Rich Repeat Kinase 2 (LRRK2) G2019S kinase inhibitor that spares wild type LRRK2 functionality. G2019S is the most common pathogenic mutation linked to PD occurring in 13% of PD patients. G2019S drives elevated kinase activity that perturbs the delicate orchestration of downstream signaling required for the healthy functioning of multiple cellular processes. ESB5070 is being developed specifically for the treatment of subjects carrying the LRRK2 G2019S variant and is currently in IND-enabling toxicology studies.

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ESCAPE Bio Closes $73 Million in Crossover Financing to Advance Clinical Development of Precision Neurology Medicines for Genetic Neurodegeneration -...

The Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Development of Case Report Forms for Global Use – DocWire News

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This article was originally published here

Neurocrit Care. 2020 Sep 18. doi: 10.1007/s12028-020-01100-4. Online ahead of print.

ABSTRACT

Since its original report in January 2020, the coronavirus disease 2019 (COVID-19) due to Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) infection has rapidly become one of the deadliest global pandemics. Early reports indicate possible neurological manifestations associated with COVID-19, with symptoms ranging from mild to severe, highly variable prevalence rates, and uncertainty regarding causal or coincidental occurrence of symptoms. As neurological involvement of any systemic disease is frequently associated with adverse effects on morbidity and mortality, obtaining accurate and consistent global data on the extent to which COVID-19 may impact the nervous system is urgently needed. To address this need, investigators from the Neurocritical Care Society launched the Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID). The GCS-NeuroCOVID consortium rapidly implemented a Tier 1, pragmatic study to establish phenotypes and prevalence of neurological manifestations of COVID-19. A key component of this global collaboration is development and application of common data elements (CDEs) and definitions to facilitate rigorous and systematic data collection across resource settings. Integration of these elements is critical to reduce heterogeneity of data and allow for future high-quality meta-analyses. The GCS-NeuroCOVID consortium specifically designed these elements to be feasible for clinician investigators during a global pandemic when healthcare systems are likely overwhelmed and resources for research may be limited. Elements include pediatric components and translated versions to facilitate collaboration and data capture in Latin America, one of the epicenters of this global outbreak. In this manuscript, we share the specific data elements, definitions, and rationale for the adult and pediatric CDEs for Tier 1 of the GCS-NeuroCOVID consortium, as well as the translated versions adapted for use in Latin America. Global efforts are underway to further harmonize CDEs with other large consortia studying neurological and general aspects of COVID-19 infections. Ultimately, the GCS-NeuroCOVID consortium network provides a critical infrastructure to systematically capture data in current and future unanticipated disasters and disease outbreaks.

PMID:32948987 | DOI:10.1007/s12028-020-01100-4

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Systolic Blood Pressure and Orthostatic Hypotension Are Linked to Dementia – Neurology Advisor

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Systolic orthostatic hypotension (OHYPO) and variability in visit-to-visit systolic blood pressure (BP) postural changes may be associated with increased risk of dementia, according to study results published in Neurology.

BP postural changes affects a significant percent of the elderly population, and various pharmacologic/non-pharmacologic interventions may improve orthostatic symptoms. Additionally, while previous studies have indicated the association between OHYPO and cardiovascular outcomes, much less is understood about the relationship of OHYPO with cognitive ones. Study researchers consequently sought to evaluate whether OHYPO and variability in visit-to-visit BP postural changes were associated with dementia.

The study included older adults (mean age, 73 years; 53% women) who were pooled from the Health, Aging, Body Composition cohort study (n=2131). In this cohort, changes in orthostatic BP were assessed at baseline and at 1, 3, and 5 years. Patients were considered to have OHYPO if they experienced a decrease of at least 15 mmHg in systolic or at least 7 mmHg in diastolic BP after standing from a sitting position for a minimum of 1 out of 3 clinic visits. Both systolic and diastolic OHYPO were assessed separately.

Variability in BP postural changes were also examined over time. Additionally, the investigators examined the prevalence of incident dementia over a 12-year period after baseline (total follow up, 17 years) by assessing dementia medication use, changes in Modified Mini-Mental State (1.5 standard deviation decline), or records of hospitalization with dementia.

A total of 309 (14.5%) patients had OHYPO, 192 (9.0%) had systolic OHYPO, 132 (6.2%) had diastolic OHYPO, and 462 (21.7%) developed incident dementia over 12 years. Systolic OHYPO correlated with greater dementia risk in a multivariable adjusted analysis (adjusted hazard ratio [HR], 1.37; 95% CI, 1.01-1.88). No significant association was found between diastolic OHYPO and increased risk of dementia (adjusted HR, 0.92; 95% CI, 0.60-1.40). Variability in systolic BP postural changes also correlated with an increased risk of dementia, particularly in the highest tertile of variability (adjusted HR, 1.35; 95% CI, 1.06-1.71).

Limitations of this study included its observational design, the lack of a formal and structured clinical assessment for dementia, and the reliance on a relatively small number of orthostatic BP measures to assess variability in BP postural changes.

The study researchers concluded that the management of orthostatic systolic BP and its variability, including with an optimization of antihypertensive treatment, could be a promising interventional target in preserving cognitive function among older adults.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors disclosures.

Reference

Rouch L, Vidal JS, Hoang T, Cestac P, Hanon O, Yaffe K. Systolic blood pressure postural changes variability is associated with greater dementia risk. Neurology. Published online July 20, 2020. doi:10.1212/WNL.0000000000010420

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Systolic Blood Pressure and Orthostatic Hypotension Are Linked to Dementia - Neurology Advisor

Voyager Therapeutics Appoints Nancy Vitale to its Board of Directors – GlobeNewswire

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CAMBRIDGE, Mass., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today announced the addition of Nancy Vitale as an independent director to its Board of Directors, effective as of September 15, 2020. Ms. Vitale brings more than 25 years of experience to Voyagers Board, with deep expertise in human resources. She is a former Senior Vice President and Chief Human Resource Officer at Genentech, a member of the Roche Group.

We are thrilled to welcome Nancy to our Board, said Andre Turenne, President and CEO of Voyager. Nancys accomplished background in helping organizations thrive by focusing on a strong patient-centric culture and employee wellbeing will be enormously valuable as we continue to grow Voyager.

Since leaving Genentech, in 2019, Ms. Vitale co-founded and continues to co-manage Partners for Wellbeing, LLC., a boutique human resources consulting firm. Prior to her 13-year tenure at Genentech, Ms. Vitale held senior human resources roles at Procter & Gamble Company and CIGNA. Ms. Vitale earned a Bachelor of Business Administration from the University of Michigan and an MBA from the Goizueta Business School of Emory University.

Im delighted to join Voyagers Board of Directors, Ms. Vitale commented. The company is led by an outstanding team and Im highly compelled by Voyagers mission to deliver life-changing medicines for patients suffering from severe neurological diseases. I look forward to working with other members of the Board and contributing to this important mission.

Ms. Vitale will also serve as a member of the Boards Compensation Committee.

About Voyager Therapeutics

Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyagers wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinsons disease, Huntingtons disease, Friedreichs ataxia, and other severe neurological diseases. For more information onVoyager Therapeutics, please visit the companys website atwww.voyagertherapeutics.com or follow@VoyagerTxon Twitter andLinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities law. The use of words such as may, might, will, should, expect, plan, anticipate, believe, estimate, project, intend, future, potential, or continue, and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding Ms. Vitales participation as a member of Voyagers Board of Directors and her ability to help Voyager grow and develop a strong patient-centric culture and focus on employee wellbeing are forward-looking. All forward-looking statements are based on assumptions by Voyagers management that, although Voyager believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected, including the ability of Ms. Vitale to quickly integrate onto the Voyager Board of Directors, to make contributions as a member of the Voyager Board of Directors and to contribute to Voyagers culture. These statements are also subject to a number of material risks and uncertainties that are described in Voyagers most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as updated by its future filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investors:Paul CoxVP, Investor Relations857-201-3463pcox@vygr.com

Media: Sheryl Seapy W2Opure949-903-4750sseapy@purecommunications.com

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Effects of Migraine on Disability and Neurological Function in MS – Neurology Advisor

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

Among patients with multiple sclerosis (MS), a history of migraine may not be associated with worse disability or neurological function, according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.

While previous studies reported that migraine is common in patients with MS, limited data exist on the effects of migraine on disability or neurological function in this population. The objective of the current study was to investigate the association between history of migraine, disability and neurological function in patients with MS. In addition, study researchers explored the association between migraine and frequency of MS relapses, and the co-occurrence of migraine with other comorbidities in patients with MS.

This observational study included patients with MS and a documented history of migraine, who completed a neurological function assessment using the MS Performance Test. Study researchers also collected data on other comorbidities, including diabetes, hypertension, dyslipidemia, history of myocardial infarction, sleep apnea, depression, and anxiety.

Disability was determined according to the Patient Determined Disease Steps tool. Additional outcomes included annualized relapse rate, rate of new brain lesions on MRI and objective neurological outcomes (walking speed, manual dexterity, and processing speed).

Of the 2017 patients with MS who completed the MS Performance Test, 336 had 1 documented diagnosis of migraine in their electronic medical record. Patients with MS and migraine were younger than those without migraine (mean age, 42.6 years vs 46.6 years, respectively; P <.001) and had higher rates of depression (46.52 vs. 48.16, P <.001), anxiety (50.29 vs 52.81; P <.01), and obstructive sleep apnea (109 vs 53, P <.001).

Severe disability was less frequent in patients with migraine compared to those without (5.4% vs 12%, respectively; P <.003), and there was no difference in objective neurological outcomes, including walking speed, manual dexterity or processing speed. Furthermore, there was no significant difference in annualized relapse rate or rate of new brain lesions in patients with MS with and without migraine.

Researchers concluded that a history of migraine was not associated with greater disability in patients with MS, but added that the evidence to date on this topic is conflicting and warrants future longitudinal studies..

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

Reference

Damian A, Hu C, Fitzgerald K, Mowry E. A history of migraine headache may not be associated with worse disability or worse neurological function. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 2020. Abstract P0423.

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COVID-19 can hide in the brains of mice, cause neurological issues – Business Insider – Business Insider

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Darius Settles was sent home from the emergency room twice after contracting COVID-19 in June. The first time, he was told to come back if his condition worsened. On his second visit, his blood-oxygen levels were normal enough to discharge him again. He died in July, the youngest person killed by the coronavirus in Nashville, Tennessee, at that time.

Situations in which patients seem better, get discharged, then see their conditions worsen, have become common over the course of the pandemic. New research suggests it may be related to infections in the brain.

"People seem to have very nice recovery, lung functions are fine, and we send them home just to find out that three days later, the patient becomes so severe that they died," Mukesh Kumar, a virologist at Georgia State University, told Insider. "That usually can only happen when the brain is involved."

Kumar recently published a study in the journal Viruses that examines how COVID-19 affects the brains of mice.

His results showed that three days after the mice were infected with the coronavirus, they displayed high levels of virus in their lungs. By days five and six, their lungs had started to clear up but their brains showed about 1,000 times more virus than the peak levels found in the lungs. That coincided with the arrival of severe symptoms such as labored breathing, disorientation, and weakness.

The virus also triggered an inflammatory response in the brain, marked by the release of chemical signals called cytokines. Under normal circumstances, cytokines tell the immune system to fight off infection but too many cytokines can instruct the body to attack its own cells, triggering dangerous levels of inflammation. The mice brains in the study showed around 10 to 50 times more cytokines than the lungs.

In some mice, the reaction caused immediate death. But in mice with milder cases, the virus seemed to hide out in the brain indefinitely.

Though results of mice studies don't always hold true for humans, Kumar suspects that the brain is a major target for the coronavirus.

"Our brain doesn't have that good immune response like our lungs or our heart, so whenever the virus goes in the brain, it can replicate very well," Kumar said. "It can stay there for a long time."

Viral replication in the brain could also explain why some coronavirus patients have persistent neurological issues, such as dizziness or brain fog, long after they've tested negative for COVID-19. In some cases, Kumar said, there's a risk these neurological problems may give rise to chronic illnesses such as autoimmune disorders, Parkinson's, or multiple sclerosis.

"Depending upon your immune response or antibody levels, it could cause low levels of inflammation, or maybe make you prone to other disease, or maybe reactivate later," he said. "All these are still outstanding questions because we are still only one year into the pandemic."

A woman improperly wears her face mask in Rome, Italy, on April 29, 2020. Andreas Solaro/AFP/Getty Images

COVID-19 is often described as a respiratory disease, since the coronavirus attacks the lungs first. But some researchers suspect it may be a vascular disease, given that some patients develop blood clots, leaky capillaries, and inflamed blood vessels, which can lead to heart damage or stroke.

ADutch study of 184 coronavirus patients in the ICU found that nearly one-third of patients had blood clots. And aJuly study of 100 COVID-19 patients found that 78 of them had some degree of heart damage. Studies have also suggested that nearly 2% of COVID-19 patients have strokes far more than than the rate of strokes among influenza patients.

But Kumar's study didn't detect any virus in the blood of infected mice.

Instead, his research showed that the virus entered the brain through the nasal passages, before attacking the central nervous system. Part of that nervous system controls our sense of smell, which may explain why many coronavirus patients have trouble smelling. Kumar said it's possible that the virus could reach the brain after entering the mouth as well, but the nose is a more direct pathway.

In mice, the coronavirus seemed to have trouble replicating in organs such as the heart, liver, or kidneys. But an infection in the brain can ultimately damage such organs, Kumar said.

"It doesn't even have to go to every organ, because if it can go to the brain, there are several parts of the brain that control all other organs," he said. "So it could also be possible that you don't even need virus in the lungs to cause lung failure."

A patient who has recovered from COVID-19, gestures next to his son as he leaves the Juarez Hospital in Mexico City, Mexico, July 27, 2020. Edgard Garrido/Reuters

Neurological issues are more common among coronavirus patients than scientists originally thought.

An October study found that 82% of coronavirus patients admitted to a hospital network in Chicago in March and April 2020 had neurological symptoms. The issues ranged from relatively minor headaches, dizziness, and loss of smell to serious conditions like brain damage, strokes, and seizures.

In some cases, these symptoms can linger for at least several months.

A recent study from University of Oxford researchers, which is still awaiting peer review, found that 13% of people who got COVID-19 were diagnosed with a psychiatric or neurological illness within six months of testing positive for the virus. Some patients even showed signs of Parkinson's disease or Guillain-Barr syndrome, a rare autoimmune disorder, but those results weren't statistically significant.

Kumar said it's fairly simple to tell whether a patient has a severe neurological condition, since the issue will likely show up on an MRI or CT scan. But mild neurological problems are often difficult to pinpoint.

"Unfortunately, based on other studies, it could be lifelong," Kumar said. "We know patients who are still showing symptoms who were infected a year ago."

The research he did on mouse brains, however, is difficult to replicate in humans.

"The patient has to die to actually find out if the virus is hiding in the brain," he said.

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COVID-19 can hide in the brains of mice, cause neurological issues - Business Insider - Business Insider

Detecting Alzheimer’s Gets Easier with a Simple Blood Test – Scientific American

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When a patient complains of forgetfulness, a neurologist might not know immediately whether it results from normal aging, reduced blood flow to the brainor, more ominously, Alzheimers disease. For much of the past century, a definitive Alzheimers diagnosis could only be made during an autopsy. Brain imaging and spinal fluid tests now make it possible to spot the disease in patients even before the initial symptoms appear. But these invasive tests are expensive and generally limited to research settings that are not part of routine care for the millions of people suffering from the most common neurodegenerative disorder.

An era in which an Alzheimers diagnosis can begin in a doctors office is now arriving. Advances in technologies to detect early signs of disease from a blood sample are helping doctors to identify the memory-robbing disorder more accurately and to screen participants more quickly for trials of potential treatments for the more than five million people in the U.S. afflicted with Alzheimers. (Estimates predict that, by 2030, there will be 76 million people worldwide who will receive a diagnosis of Alzheimers or other dementias.)

Last fall, a blood test developed by C2N Diagnostics in St. Louis, Mo., became available to most of the U.S. as a routine lab testregulated under the CMS Clinical Laboratory Improvement Amendments (CLIA) program. It has also received a CE mark as a diagnostic medical device in the European Unionindicating it has met safety, health and environmental protection standards for the region.

The development of a blood-based test for Alzheimers disease is just phenomenal, says Michelle Mielke, a neuroscientist and epidemiologist at the Mayo Clinic. The field has been thinking about this for a very long time. Its really been in the last couple of years that the possibility has come to fruition.

The C2N test, called PrecivityAD, uses an analytic technique known as mass spectrometry to detect specific types of beta-amyloid, a protein fragment that is a pathological hallmark of disease. Beta-amyloid proteins accumulate and form plaques visible on brain scans two decades before a patient notices memory problems. As plaques build up in the brain, levels of beta-amyloid decline in the surrounding fluid. Such changes can be measured in spinal fluid samplesand now in blood, where beta-amyloid concentrations are significantly lower. PrecivityAD is the first blood test for Alzheimers to be cleared for widespread use and one of a new generation of such assays that could enable early detection of the leading neurodegenerative diseaseperhaps decades before the onset of the first symptoms.

PrecivityAD is meant for 60- to 91-year-olds with early signs of cognitive impairment. The prescribing physician ships patient blood samples for analysis at C2Ns lab and receives results within 10 business days. The resultsa probability score that reflects the likelihood of an amyloid-positive brain scanare calculated using a proprietary algorithm that incorporates the persons age with measurements of beta-amyloid and a protein called apolipoprotein E that is known to influence Alzheimers disease risk.

Rather than serving as a stand-alone tool, the results are meant to enhance the accuracy of a clinical diagnosis by distinguishing Alzheimers dementia from memory loss caused by other conditions. The test costs $1,250 and is not currently covered by insurance, though a financial assistance program can bring out-of-pocket costs down to between $25 and $400 for eligible patients, says C2Ns chief executive Joel Braunstein.

By comparison, beta-amyloid tests using positron-emission tomography (PET) brain imaging typically cost around $5,000 and are typically not covered by insurance, and those that sample cerebrospinal fluid (CSF) usually cost from $800 to $1,000. Compared with these more invasive and burdensome procedures, the ease and lower cost of blood tests open up many exciting possibilities for clinical use and therapeutic development, says Adam Boxer, a neurologist at the University of California, San Francisco. Blood tests can be collected from people repeatedly in remote locations or in their homes. No drugs have yet been approved that change the course of Alzheimers. But readily available early tests could improve treatment by letting patients take measures to stay healthy, affording them an opportunity to plan for an uncertain future and participate in clinical trials.

From a preventive standpoint, blood tests could help identify whos at risk, Mielke says. Testing could also be used to screen potential participants for experimental drugs. In some past trials of beta-amyloid-reducing treatments, 15 to 30 percent of patients who met clinical criteria for Alzheimers turned out not to have brain amyloid. Nowadays trials often require participants to show evidence of disease pathology through PET scans or CSF measures. Prescreening with a cheap blood test could halve the number of PET scans needed to enroll volunteers, according to a new study published on January 22 in the journal Brain.

This would lower the cost of trials, which means more potential treatments can be tested, and that increases the chances of finding a cure, says Elisabeth Thijssen, a researcher studying blood biomarkers for Alzheimers at Amsterdam University Medical Centers in the Netherlands. Blood tests would be particularly helpful in identifying patients for trials of potential drugs that could be most effective long before the first symptom of cognitive decline.

Looking for beta-amyloid is not the only option. Some researchers believe other disease markersfor example, certain forms of the protein taucould prove more promising when incorporated in blood tests for Alzheimers. Beta-amyloid levels start to drop very early in the disease process and then reach a plateau, whereas tau markers go up later and continue to rise. That observation suggests amyloid tests could work better for early detection while tau levels are more meaningful at later stages of the disease, when someone is on the verge of decline or already symptomatic, says Oskar Hansson, a neurologist at Lund University in Sweden. Last year Thijssen and Hansson published separate studies showing that tau blood tests could distinguish Alzheimers from other neurodegenerative diseases nearly as well as CSF measurements and PET scans. Quanterix, a company in Billerica, Mass., has developed an immunoassay that detects amyloid and tau in conjunction with other neurological markers and inflammatory proteins. So far these tests are not available outside of research settings.

We researchers are super enthusiastic about these tests, Thijssen says. Most studies have been conducted in extensively studied groups of patients in neurology clinics, however. Now we have to make the step into the real world, she says. When a new patient comes in with memory complaints, is a blood test going to help physicians make a proper diagnosis?

Patients in other settings may have other ailments that could affect the accuracy of assays. Some medical conditions can influence the levels of blood proteins, possibly skewing test results. If somebody has chronic kidney disease, that can affect the clearance of proteins, Mielke says. Individuals with a high body mass index tend to have higher blood volume, so that could reduce protein levels.

UCSF neurologist Gil Rabinovici agrees that all these markers need to be validated in more diverse and generalizable cohorts. He is helping to lead a new study that will test blood assays against amyloid PET scans in 5,000 patients recruited at 350 clinical siteswith an emphasis on patients from Black and Latinx populations, which are historically underrepresented in dementia research.

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American Neurological Association’s First-Ever All-Virtual, Interactive Meeting Attracts Record Attendance from 47 Countries With Special Focus on…

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Newswise The 145th Annual Meeting of the American Neurological Association, its first-ever virtual, interactive event, was attended by 1,421 members and guests from 46 countries and the U.S.A., a greater number than attended any Meeting in recent years. The five-day program which ran from October 4, 2020 through October 9, 2020, featured 67 sessions, with a strong focus on the ground-breaking science being conducted by the Associations early-career members.

This year, we added four Emerging Scholar sessions and highlighted the work of our junior and early career members with the Derek Denny-Brown Young Neurological Scholars symposium, explained ANA2020 Meeting Chair Conrad Chris Weihl, MD, PhD. These symposia were very well-received and well-attended, reflecting the excitement in the research community for this work.

In addition, the Meeting showcased an extensive number of poster abstract submissions, all of which demonstrated that extraordinary work is taking place at all career levels across all subspecialties, and reaffirming that ANA is committed to fostering and advancing academic neurology and neuroscience, Weihl noted.

The Meeting featured 18 Special Interest Group (SIG) Networking sessions this year, which provided an opportunity for members at all career levels to benefit from an exchange of ideas and exploration of the newest science in their respective fields. Also new this year was a Social Justice Symposium, which took place the day before the official start of the meeting, and featured an in-depth exploration of such topics as the impact of social determinants of health, adverse health outcomes for people of color, and health-care policy. In addition, participants participated in interactive breakout sessions designed to develop actionable steps to address inequity within academic neurology and neuroscience.

Members responded enthusiastically to the virtual, interactive format, commenting on the opportunities for networking that were still core to ANAs strong tradition of fostering relationships within the neuroscience and neurology research and educational communities. As an assistant professor, I look to ANA for opportunities for mentorship and networking that can help advance my career, and I wasnt sure this could be accomplished in a virtual setting, said Elizabeth Silbermann, MD But there were a surprising number of virtual sessions that allowed us to gather and discuss the topics we would be exploring in a live meeting setting. It was a great experience, and I ended the Meeting with a number of professional contacts Im excited to reach out to again.

Following the Annual Meeting, ANA announced the recipients of the Poster Awards, and the Emerging Scholar Awards.

ABOUT THE ANA

The American Neurological Association is a professional society of academic neurologists and neuroscientists devoted to advancing the goals of academic neurology; to training and educating neurologists and other physicians in the neurologic sciences; and to expanding both our understanding of diseases of the nervous system and our ability to treat them.

For more information, visit http://www.myana.org or follow @TheNewANA1 on Twitter, @AmericanNeurologicalAssociation on Facebook, or @ananeurology on Instagram.

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IDSA, AAN, and ACR Release Guidelines for Prevention, Diagnosis, and Treatment of Lyme Disease – Newswise

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Newswise New evidence-based clinical practice guidelines for the prevention, diagnosis, and treatment of Lyme disease have been developed by a multidisciplinary panel led by the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology. Representatives from an additional 12 medical specialties and patients also served on the panel.

The guidelines provide practical recommendations for clinicians treating patients with Lyme disease, including, but not limited to, primary care physicians, infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists, and dermatologists.

These recommendations aim to serve as a meaningful resource for the safe, effective, evidence-based care of people with Lyme disease. They address clinical questions related to the prevention, diagnosis, and treatment of Lyme disease; complications from neurologic, cardiac, and rheumatic symptoms; disease expression commonly seen in Eurasia; and complications from coinfection with other tick-borne pathogens.

The guidelines include 43 recommendations related to diagnostic testing, including testing scenarios (such as for certain neurologic, psychologic, behavioral, cardiac, and rheumatologic syndromes); detailed recommendations about Lyme carditis; and a discussion of chronic Lyme disease.

Among the diagnostic testing recommendations, the guidelines recommend clinical diagnosis without laboratory testing for people with a skin rash characteristic of early Lyme disease. For people with other signs of Lyme disease, such as swollen joints or meningitis, the guidelines recommend antibody testing.

Among the treatment recommendations, the guidelines recommend oral antibiotic therapy for most patients with Lyme disease. The recommended duration of therapy is 10 to 14 days for early Lyme disease, 14 days for Lyme carditis, 14 to 21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis. Retreatment may be indicated for individuals with arthritis who have failed a first course of treatment.

The recommendations are grounded in a rigorous, systematic review of available evidence surrounding prevention, diagnosis and treatment of the disease. The panel adhered to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and strength of recommendations. The guidelines are voluntary and it is up to clinicians to determine which treatments are best for individual patient scenarios.

Each of the three sponsoring organizations elected a co-chair to lead the guideline panel. A fourth co-chair was selected for their expertise in guideline methodology. A total of 36 panelists comprised the full panel, and the panel also included three patient representatives and one health care consumer representative.

About 30,000 cases of Lyme disease are reported annually, but the Centers for Disease Control and Prevention estimates there are more than 300,000 cases in the United States each year.

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About IDSA

The Infectious Diseases Society of America is a community of over 12,000 physicians, scientists, and public health experts who specialize in infectious diseases. Its purpose is to improve the health of individuals, communities, and society by promoting excellence in patient care, education, research, public health, and prevention relating to infectious diseases. Learn more at https://www.idsociety.org/.

About AAN

The American Academy of Neurology is the worlds largest association of neurologists and neuroscience professionals, with more than 36,000 members. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. Learn more at https://www.aan.com/.

About ACR

The American College of Rheumatology (ACR) is an international medical society representing over 7,700 rheumatologists and rheumatology health professionals with a mission to empower rheumatology professionals to excel in their specialty. In doing so, the ACR offers education, research, advocacy, and practice management support to help its members continue their innovative work and provide quality patient care. Learn more at https://www.rheumatology.org/

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Dr. Tzurei Chen Publishes Chapters on Neurologic and Geriatric Physical Therapy – Pacific University

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Dr. Tzurei Chen recently collaborated with Dr. Kevin Chui to publish two chapters in two textbooks frequently adopted in entry-level physical therapy education and used in clinical practice. Both textbooks are also used by physical therapists as preparatory resources for American Board of Physical Therapy Specialties exams. The first chapter is on proprioceptive neuromuscular facilitation for select patient populations including those with neurologic dysfunction, amputation, and chronic low back pain. The second chapter is on impaired joint mobility for older adults and addresses all of the elements of patient/client management. Both chapters incorporate the most recent evidence to inform clinical-decision making.

References:

Chen T, Chui K. Proprioceptive neuromuscular facilitation. In Martin S, Kessler M, eds. "Neurologic Interventions for Physical Therapy." St. Louis, MO: Saunders; 2020: 294-347.

Chui K, Yen SC, Chen T, Christiansen C. Impaired joint mobility in older adults. In Avers D, Wong R, eds. "Gucciones Geriatric Physical Therapy." St. Louis, MO: Elsevier; 2020: 344-364.

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Dr. Tzurei Chen Publishes Chapters on Neurologic and Geriatric Physical Therapy - Pacific University

Scotland allocates 500,000 for treatment of neurological conditions – Health Europa

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The investment, which totals 492,535, will be directed specifically towards initiatives which focus on delivering treatment in partnership with the NHS and the third sector; and forms part of the governments 4.5m five-year action plan to ensure patients living anywhere in Scotland can access personalised neurological care and support.

The Neurological care and support: framework for action 2020-2025 programme sets out the governments vision for improving the quality of life of adult patients with neurological conditions by raising the standard and availability of care and treatment which they are able to access; as well as by sourcing and distributing information and support around living with neurological issues.

Joe FitzPatrick, Scotlands Minister for Public Health, said: Around one million people in Scotland live with a neurological condition ranging from common conditions such as migraines to life-limiting illnesses such as motor neurone disease (MND). We recognise the scale, variety and context of neurological conditions and how distressing they can be for the person with the condition and their family and the framework for action aims to support those responsible for providing care and support to people affected. This latest round of funding will ensure this vital work not only continues but is strengthened despite the challenges faced during the pandemic.

One recipient of the new funding is the PSP Association (PSPA), a charity which offers information and support to people affected by progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). PSPA CEO Andrew Symons said: Neurological Care and Support Framework Funding will allow us to map provision for PSP and CBD in Scotland, simultaneously highlighting the information and support that we can offer from PSPA. This will contribute to the aim of earlier diagnosis of these rare conditions and reduce the time spent by people in the wrong part of the system with the result they can benefit from the provisions of the Framework as soon as their disease is recognised.

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Dartmouth-Hitchcock neurologist named Tech Professional of Year – New Hampshire Business Review

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TechWomen/TechGirls honor recognizes her work in epilepsy treatment

D-H neurologist Barbara Jobst was named 2020 Tech Professional of the Year by the NH Tech Alliance.

Dartmouth-Hitchcock neurologist Dr. Barbara Jobst has been named the 2020 Tech Professional of the Year at the NH Tech Alliances fifth annual TechWomen/TechGirls awards luncheon, which was held virtually earlier this month.

The annual award acknowledges the accomplishments of New Hampshire women who contribute to help advance STEM education and professional STEM advancements for women throughout the state.

Jobst, co-director of the Dartmouth-Hitchcock Epilepsy Center at Dartmouth-Hitchcock Medical Center in Lebanon, is the section chief for adult neurology and vice chair of the Neurology Department at DHMC. She is also the Louis and Ruth Frank Endowed Professor of Neurosciences at the Geisel School of Medicine at Dartmouth.

Jobst is a clinician-investigator who applies advanced technology to benefit patients and has trained many students, residents, fellows and junior faculty in using technology to advance medicine. She and her team have participated in multiple multicenter trials involving brain stimulation and she has studied the interaction of memory and epilepsy.

Her work has included improving memory with deep brain stimulation as well as developing and implementing a cognitive-behavioral program for memory problems in epilepsy.

I am honored to be recognized by the NH Tech Alliance, and applaud their efforts to illuminate the work of women in STEM fields and in promoting STEM opportunities to girls and young women throughout the state, Jobst said.

Originally from Germany, Jobst attended Dartmouth Medical School (now known as the Geisel School of Medicine) for four months in 1992 as a medical exchange student. She returned to the United States in 1996 as a medical resident at DHMC after earning her medical degree, and has been with D-H ever since.

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New Studies, New Perspectives on the Neurologic Effects of… : Neurology Today – LWW Journals

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Article In Brief

Two new research studies focus on the neurologic issues that present in patients with COVID-19: One proposes that the disease that starts in the respiratory tract brings on coagulopathy and stroke risk, while the other asserts that, so far, the neurologic effects of the virus does not appear to involve direct invasion of the central nervous system.

Two new studies attempt to bring into focus neurological issues that present in patients with COVID-19: One proposes that the disease that starts in the respiratory tract brings on coagulopathy and stroke risk, and another asserts that, so far, the virus' neurologic effects do not appear to involve direct invasion of the central nervous system (CNS).

The studies represent two of the latest publications in the expanding literature on the virus and its neurological manifestations, which reflect an updated understanding that COVID-19 is not merely a respiratory phenomenon.

In an August 10 online report in the Journal of Neuroimaging, the authors proposed a cascade of events they say could be taking place in COVID-19 patients after the virus escapes the respiratory system and gets into the bloodstream, a process they say points to the potential for specific modes of therapy tailored to different steps in the cascade.

The authorstwo of whom are associated with a company that has developed a tool that, once approved, could be used to treat the type of patients they describesay that after the virus enters the alveolus of the lung, it causes inflammation that damages the thin membrane between the alveolus and the adjacent lung capillary, or the blood-air barrier.

Then a potentially disastrous string of events begins, first with the development of endothelial dysfunction. This happens, they say, in one of two ways: Either the virus enters endothelial cells directly, or damaging angiotensin II accumulates because their usual docks, angiotensin-converting enzyme 2 (ACE2) receptors, become occupied by the virus, which has a high affinity for the receptors. The angiotensin II leads to oxidative stress and oxidation of the typically circular Beta2glycoprotein1 (B2GP1) but becomes unwound into a J shape.

At that point, the authors posit, there is an opening on B2GP1 for antiphospholipid antibody complexes, associated with thrombotic tendencies, to form. The lack of non-oxidized B2GP1 to competitively bind von Willebrand Factor leads to platelet adhesion and platelet attachment to sub-endothelial collagen, and then to platelet activation and aggregation in the setting of the thrombosis-friendly antiphospholipid antibodies. In the worst cases, the resulting clots lead to pulmonary emboli or stroke from large vessel occlusion.

Vallabh Janardhan, MD, the paper's lead author and a stroke and interventional neurologist at the Medical Center of Plano, said that a proper understanding of the process points to opportunities to intervene therapeuticallywith antiplatelet, antithrombotic, and antifibrinolytic therapy, and if necessary, with clot-removal devices.

In some cases, you don't have all day to dissolve the clothalf the brain will die, he said. So you need to go pull out the clot with clot-removal devices and initiate blood thinners, so it doesn't re-clot.

With his brother Vikram Janardhan, he co-founded Insera Therapeutics, which has developed a clot-removal system using intermittent or cyclicalrather than continuoussuction designed to be gentler on the vessel and for better removal of clots.

We believe, yes, there was a lot of attention towards ventilators early onthat's because we didn't connect the dots at that time, Vikram Janardhan said. Now that we're connecting the dots, there are other therapeutics that are a better fit in reducing mortality than an exclusive concern on the number of ventilators.

Insera's device is approved in Europe but not the United States and is not yet commercially launched.

We fully anticipate and hope the vaccines will be out and available before our therapy is ready worldwide, Vikram Janardhan said.

The other paper, which was published in the August 19 issue of Cell, conveys the broad scope of the neurological manifestations seen in COVID-19 patients.

Neurological abnormalities have been described in 30 percent of patients. But the most frequent neurological problemsespecially malaise, dizziness, and headachetend to be confined to non-specific abnormalities in patients experiencing mild COVID-19, said lead author Constantino Iadecola, MD, director of the Feil Family Brain and Mind Research Institute at Weill Cornell. Among those with more severe diseases requiring hospitalization, neurological manifestations are more severewith ischemic stroke and encephalopathy, for example, Dr. Iadecola said.

While serious neurological complications have been reported in patients with otherwise mild COVID-19, the most severe complications occur in critically ill patients and are associated with significantly higher mortality, he said.

COVID-19 is a much more aggressive disease, he said, noting that to date, no convincing evidence shows that the virus directly infiltrates neurons.

There's no evidence that this is a neurotropic virus, he said. In the case of the loss of smell, he said, some cells in the nasal cavity, such as epithelial cells, might become infected, but there is no definitive evidence that the nerves themselves are invaded.

Most of the neurological problems seen in COVID-19 patients, he said, result from systemic effects on the virus, Dr. Iadecola said.

He cautioned, though, that the data that has been published so far has mostly come from the most serious cases.

We're not going to know maybe until a year from now when you look at the population as a whole, the real mortality, the real incidence of neurological manifestations, and the most prevalent neurological manifestations, he said. Because now we know only the patient who gets very, very sick and goes to the hospital and may be intubated.

The most pressing research questions remaining, he said, include whether neurological manifestations of COVID-19 reflect brain invasion, whether the brain contributes to immune dysregulation and respiratory failure, and the long-term neurological consequences of the virus.

He urged centers treating COVID-19 patients to establish systems to track patients longitudinally.

The mortality from the COVID-19 virus may not be extremely high, he said, but a lot of people are getting infected. Evidence from other viral infections suggests that even if you have a mild infection .... there could be long-term neuropsychiatric effects that range from anxiety, PTSD, and depression, to cognitive impairment.

The message for clinicians, he said, is to be aware that the major complications that come from this are most likely due to whatever is going on elsewhere in the body, especially the hypercoagulable state and hypoxia. That's what the evidence so far suggests. They've got to pay almost more attention to what goes on outside the brain because most likely what goes on in the brain may be a reflection of that. And then pay attention to the sequelaewhatever it is going to be coming up in the next several months.

Be very attentive to the patients, he continued. Ask general questionsabout their mood, sleep pattern, appetite, social life, and whether they've gone back to work, he suggested.

As the acute phase resolves, quality of life is going to be paramount, Dr. Costantino said.

Adnan I. Qureshi, MD, FAAN, professor of clinical neurology at the University of Minnesota, who has studied COVID-19, said there are two main ways the virus can affect the CNS. One is a direct effect by the virus or inflammation affecting neuronal cells and the blood-brain barrier. These patients can get encephalitis or have demyelination, but it's unclear whether there is any treatment except for a therapy that can suppress the excessive inflammation, such as IL-6 inhibitors.

The second is through blood-clotting mechanisms, he said.

Some large studies, including one of ours, [published in July in the International Journal of Stroke], has shown that patients who develop ischemic stroke with COVID-19 are at risk due to older age and high prevalence of hypertension, diabetes mellitus, and hyperlipidemia. Therefore, these patients have other cardiovascular risk factors for ischemic stroke. COVID-19 may simply be a precipitant like other respiratory and systemic infections.

Important pending questions, Dr. Qureshi said, include how to best manage neurological patients, since focusing on neurological aspects alone might not be enough; the effect of remdesivir and convalescent serum; the role of anticoagulation in those with stroke risk; and the length of time stroke risk lasts after the infection.

Drs. Vallabh and Vikram Janardhan report receiving grants from the National Science Foundation and Insera Therapeutics. Dr. Vallabh Janardhan has also received grants from the Society of Vascular and Interventional Neurology. In addition, he and his brother, Dr. Vikram Janardhan, have 20 patents pending with the US Patent and Trademark Office and more than 65 patents in the US and worldwide issue.

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Brain-Computer Interfaces Move Forward at the Speed of Musk : Neurology Today – LWW Journals

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Article In Brief

A brain-computer interface (BCI), developed by a company tied with Elon Musk, offers an innovative new technology to move the field forward. But independent experts said some of the claims about what that technology can potentially do are somewhat hyperbolic at this stage. Other efforts around BCI are also featured.

It's going to blow your mind, said Elon Musk, the billionaire founder and CEO of Tesla, SpaceX and Neuralink. Speaking via a webcast on August 28, Musk introduced the latest developments, or at least made the latest claims, regarding Neuralink's brain-computer interface (BCI), a computer-based system that measures and analyzes brain activity and then converts signals into commands that are relayed to output devices that carry out the desired action.

The US Food and Drug Administration (FDA), he announced, had given the company a Breakthrough Devices Designation, and good progress, he said, was being made toward clinical trials.

As evidence of that progress, Musk presented what he called the Little Pigs demo. Three pigs in the webcast looked equally healthy, but one of them had been implanted with a device that was wirelessly transmitting neural spikes from the snout area of its brain as it rooted around in a pen.

There's a lot of function that this device could do related to monitoring your health and warning you about a possible heart attack or stroke, and convenience features like playing music, Musk said. It's sort of like if your phone went in your brain.

He predicted that, one day, you will be able to save and replay memories...Over time we could actually give someone super vision. You could have ultraviolet or infrared, or seeing radar, and actually have superhuman vision.

Alas, none of those capabilities has ever been demonstrated by Musk's company or, for that matter, by any scientist or company. Neurologists and neuroscientists who have been laboring in the field for over a decade seek not to endow healthy humans with superpowers, but to help people with neurodegenerative diseases, strokes or traumatic injuries to regain speech and motor functions. Despite that disconnect, however, leaders in the field told Neurology Today that they are impressed by the legitimate progress Neuralink appears to have made.

The company's implantable device, they say, is doing things that none of their own devices have yet achieved: It communicates to a nearby computer wirelessly, rather than through wires; its low-powered battery, also recharges wirelessly, lasts up to a day; it bristles with over a thousand electrodes, compared to a few hundred in traditional arrays; and rather than attaching those electrodes to inflexible shanks, the Neuralink device uses flexible threads so delicate they are implanted by a robotic sewing machine.

If indeed they have made a device that can detect a thousand channels with good fidelity, and it can scan through this wireless technology, that is an important development, said Karunesh Ganguly, MD, PhD, associate professor of neurology at the University of California, San Francisco. At some point, you want to see it peer reviewed to know that what they're identifying as a neuron is actually a neuron. But they do seem to be pushing the technology ahead.

More evidence of progress in the BCI field came with a September 7 report by Dr. Ganguly's group in Nature Biotechnology. Unlike other approaches for invasive BCIs, his plug and play system based on electrocorticography (ECoG) has permitted an individual with tetraplegia to maintain control of a computer cursor without daily recalibration and retraining.

While he and other scientists in the BCI field expressed some skepticism about some of the claims made by Neurolink and Musk, they told Neurology Today they appreciate the interest that Neuralink is bringing to the field.

It will be really important, as these technologies become available, hopefully over the next few years, for neurologists to become familiar with how BCI can help the patients they see in their daily practice, said Leigh Hochberg, MD, PhD, FAAN, professor of engineering at Brown University, senior lecturer in neurology at Harvard Medical School, and director of the Center for Neurotechnology and Neurorecovery at Massachusetts General Hospital.

As a neurologist, I am completely focused on developing and testing technology that will help patients I see who have paralyzing disorders to maintain or regain their ability to move and speak.

Companies like Neuralink, he said, are essential to achieving that goal.

At the end of the day, neither universities nor academic medical centers make the final marketed and supported medical devices that become available to patients outside of clinical trials, Dr. Hochberg said. That is always done by a company. The engagement of companies in this field will ultimately benefit our patients.

Although Neuralink has not published a description of its technology in peer-reviewed scientific literature, and neither Musk nor any of the scientists working for him responded to requests for interviews, some detailed descriptions have appeared on the preprint server bioRxiv.

In March of 2019, Philip Sabes, PhD, of the University of California, San Francisco (and a founding team leader at Neuralink) was the lead author of a paper describing the sewing machine his group had developed with funding by the Defense Advanced Research Projects Agency (DARPA).

The fixed, rigid metal arrays used since the 1950s to penetrate the brain, the paper noted, disturbs the vasculature and attracts immune cells. Thinner, more flexible probes, however, would not be stiff enough to insert into the brain directly. Dr. Sabes' solution was to design a system that works like a sewing machine, with stiff needle-like injectors that implant polymer probes with the aid of a neurosurgical robot.

Each of the system's 96 polymer threads, the paper stated, holds 32 electrodes, for a total of 3,072 electrodes. We developed miniaturized custom electronics that allow us to stream full broadband electrophysiology data simultaneously from all these electrodes. We packaged this system for long-term implantation and developed custom online spike detection software that can detect action potentials with low latency.

Five months later, in August of 2019, Musk was listed as the first author of another preprint on bioRxiv that described Sabes' sewing machine as part of Neuralink's BCI platform. We have built arrays of small and flexible electrode threads, Musk's paper stated, with as many as 3,072 electrodes per array distributed across 96 threads.

As described by Musk in his webcast in August, implantation of the company's device will require removal of what he called a coin-sized piece of skull by its robot. Then the device replaces the portion of skull that we removed.

Technological advances already made and anticipated from the Neuralink effort are remarkable and will serve the neuroengineering community well, Lee E. Miller, PhD, Distinguished Professor of Neuroscience at the Feinberg School of Medicine of Northwestern University, said. This scale of private investment of financial and intellectual effort is unprecedented in our field. He added, however, that the company needs to demonstrate that its device is doing what it claims to be doing.

They showed these rasters of brain activity on the webcast, with cool bloopy sounds, he said. For peer review, I would insist on seeing the actual signals they recorded. Although there is no reason to believe it to be the case, they could be recording movement artifacts.

My hunch is that it will not be as expensive as deep brain stimulation for Parkinson's disease, which costs tens of thousands of dollars. But it's going to be more expensive than, say, LASEK surgery.

DR. LEE MILLER

When I was first approached about working on brain-machine interfaces, I thought, This is crazy. But we went farther than we could have reasonably hoped to do. That's why I'm not completely closed to the wildest claims Musk makes. It's not insane that maybe one day we can replay memories.

DR. SLIMAN BENSMAIA

Dr. Miller also took issue with Musk's prediction that a BCI device could eventually cost as little as a few thousand dollars. That's not going to happen any time soon, Dr. Miller said. My hunch is that it will not be as expensive as deep brain stimulation for Parkinson's disease, which costs tens of thousands of dollars. But it's going to be more expensive than, say, LASEK surgery.

He also disagreed with Musk's over-the-top claims about recording and replaying memories.

There's a lot of science in the realm of memory, he said, including Wilder Penfield's decades-old work that appeared to show existing memories being triggered by electrical stimulation of the brain's temporal lobes during neurosurgery.

That's a far cry, however, from suggesting it would ever be possible to record from a particular memory and play it back, Dr. Miller continued. While short-term, working memory very likely is based on reverberating neural activity and amenable to the intriguing hippocampus memory prosthesis that Ted Berger has been working on, long-term memories almost certainly require protein synthesis and structural changes to neurons that couldn't even be recorded, let alone played back. That's pure science fiction, and to suggest otherwise sets up all sorts of false expectations.

Sliman Bensmaia, PhD, the James and Karen Frank Family Professor of Organismal Biology and Anatomy at the University of Chicago, runs a laboratory there devoted to research in somatosensory neuroscience and prosthetics. Earlier this year, before COVID-19 restrictions began, he visited the Neuralink offices and gave a talk.

There's a team of really great people working there, and the device they have come up with is really remarkable, Dr. Bensmaia said. The device that I work with, that almost everyone works with, the only device that has been used in humans so far, is the Utah array, made of metal microelectrodes. It's like a mini bed of nails that you press into the brain. Of course the brain doesn't like that, and the electrodes don't last. So the fact that Neuralink has these thin, flexible fibers should cause much less damage. And they have a lot more electrical contacts. The question is how robust and stable it will be. Will it last for decades? But it's pretty cool. It's way further along now than it was just six months ago when I visited them.

Despite all that, Dr. Bensmaia added, Then there is Musk and the way he talks about it. Some of the stuff he says is outrageous. It might be possible to achieve some of the things he's talking about one day, but it won't happen for a very long time.

Even so, he said, the progress made in the field in recent years is already beyond anything he thought possible in such a short time.

I participated in DARPA's Revolutionizing Prosthetics program, he said. When I was first approached about working on brain-machine interfaces, I thought, This is crazy. But we went farther than we could have reasonably hoped to do. That's why I'm not completely closed to the wildest claims Musk makes. It's not insane that maybe one day we can replay memories.

In fact, a 2018 paper published in the Journal of Neural Engineering described a study involving epilepsy patients with surgically implanted electrodes near the hippocampus whose electrical spikes were recorded and analyzed while they performed a memorization task. When scientists stimulated the CA1 region by playing back the sequence of neural firing made when the subjects correctly remembered a preliminary set of memorizing tasks, their performance on subsequent memorization tasks improved by 35 percent.)

Dr. Hochberg leads the BrainGate consortium, which includes researchers from Massachusetts General Hospital, Brown University, the Providence VA Medical Center, Stanford University and Case Western Reserve.

Over the past few years, in our published research, the participants in our trial who had very little or no movement of their arm or hand have been able to control an unmodified tablet computer for email, for texting, for controlling their music players, Dr. Hochberg said.

I used to say it would take decades before a BCI is available to people outside of research trials that could offer a true clinical benefit. I now think we are just a few years away. Right now these systems often require the oversight or engagement of a trained technician to start the system and calibrate it at the beginning of each day. We need it to work 24 hours a day, seven days a week, in the absence of any technical oversight. On all those merits, we are on track to achieve that goal with a flexible, powerful and reliable system.

Because Mass General has a clinical research support agreement with Neuralink, Dr. Hochberg said he should not speak specifically about the company. But, he said, I'm excited by the entrants of multiple companies to the BCI field. The engagement of companies will ultimately benefit our patients who have neurological disease or injury.

As for those neurologists who remain leery of a field in which companies like Neuralink are publishing accounts of apparent gains in preprints posted without peer review, a University of Toronto fellow said, essentially, this is a sign of things to come in this burgeoning world of technology.

What we are seeing is a shift to Silicon Valley-style neurotechnology companies that attract venture capital and a lot of talent quickly, said Graeme Moffat, PhD, a former managing editor of Frontiers in Neuroscience who now also runs a company developing non-invasive brain imaging devices.

The pace of iteration in fields that adopt this approachseveral new electronics designs every year and regular software updatesis too fast for journal review cycles. We'll see papers on the long term effects of new BCIs on the brain, but the peer-reviewed scholarly literature is just unsuited to reflecting the rapid innovation in devices like those that Neuralink is building.

Dr. Ganguly has received a one-time consulting fee from Lightside Medical, a medical incubator company. Dr. Stavisky is a scientific advisor to Vorso Corporation and Broad Mind Inc. and has equity in both companies. Dr. Angle owns stock and is employed by Paradromics. Drs. Miller, Bensmaia, and Moffat had no disclosures.

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Brain-Computer Interfaces Move Forward at the Speed of Musk : Neurology Today - LWW Journals

Free sessions on legal and financial issues for those with neurological conditions – Norton Healthcare

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The 2020 Neuroscience Expo will host a morning of free online sessions with legal and financial advisers, tailored exclusively to those dealing with a neurological condition and their caregivers.

Living a happy, fulfilling life goes beyond exceptional medical care. It includes caring for the whole person and their day-to-day struggles.

This Norton Neuroscience Institute event gives individuals living with a neurological condition and their family, caregivers, support care providers and others a way to collect valuable information.

Friday, Oct. 23, 9 a.m. to 12:30 p.m.

This years Norton Neuroscience Institute conference will be livestreamed, but space is limited.

Register Today

This years track for legal and financial resources features the following sessions:

Learn how to create a life care plan for you or a loved one.

Jefferey Yussman and Gordon Homes

Living with a disability can be challenging and requires planning for future needs. Youll learn ways you can financially prepare for the future.

Jefferey Yussman and Gordon Homes

If you wanted to know about the importance of having your affairs in order, this presentation will outline the various legal documents that would ensure your peace of mind.

Victor E. Tackett Jr.

Is it time to apply for disability? Where do I begin? Learn the latest on Social Security disability applications and the process of filing a disability claim.

Sam Schad

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Free sessions on legal and financial issues for those with neurological conditions - Norton Healthcare

A Grand Initiative to Improve Coma Care in Disorders of… : Neurology Today – LWW Journals

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Article In Brief

The Society of Neurocritical Care has launched a new campaign to encourage research that enables clinicians to better understand not only acute coma but also disorders of consciousness broadly, including patients with altered consciousness. Efforts will also focus on better understanding the anatomical and physiological commonalities across disorders.

In response to huge gaps in the way patients in a coma with disorders of consciousness (DoC) are treated, the Scientific Advisory Council of the Neurocritical Care Society (NCS) has initiated an ambitious initiative, the Curing Coma Campaign, to identify critical areas of research and treatment protocols.

The campaign, described in an August paper in Neurocritical Care, identified three major pillarsthe identification of endotypes, development of biomarkers, and initiation of proof-of-concept trialsas essential to a grand effort that NCS leaders are likening to a moonshot. The campaign aims to jump start research but also to expand the curing coma community to ensure broad participation of clinicians, scientists, and patient advocates with the goal of developing treatments to improve the outcome of patients.

The way we treat coma and disorders of consciousness has not been sufficient, and there are huge gaps in our understanding and in the way, we are caring for patients, said J. Claude Hemphill, MD, FAAN, professor of neurology at the University of California, San Francisco, a lead author of the paper.

We know this is not going to be easy. It's a grand challenge, and it will not be quick. We have set out a ten-year scientific road map recognizing that advances will come incrementally over time.

Dr. Hemphill emphasized that the campaign is aimed at better understanding not only acute coma but also disorders of consciousness broadly, encompassing patients with altered consciousness that may be less complete than coma. And the campaign aims to move beyond the traditional focus on disease-specific DoCcardiac arrest, traumatic brain injury, brainstem stroketo better understand the anatomical and physiological commonalities across disorders.

We have had a lot of failed clinical trials in neurocritical care using a one-size-fits-all approach, Dr. Hemphill said. Instead of saying, `let's study this treatment or clinical approach for this disease-related DoC,' we need to step back and try to understand the fundamental underpinning of all DoC.

Toward that end, The Curing Coma Campaign Scientific Advisory Committee met for the first time in person during the NCS Annual Meeting in Vancouver in October 2019, where the council outlined three overarching, interrelated areas of research necessary to move the field forward: 1) endotypingdeveloping a better understanding of the different types of coma, 2) biomarkersevaluating current tools and their shortcomings in understanding coma and its prognosis, and developing new biomarkers that accurately determine DOC endotypes, and 3) proof-of-concept clinical trialsidentifying early interventional studies to evaluate new treatment protocols and inform clinical trial design.

Dr. Hemphill said the campaign grew out of a 2017 strategic planning meeting of the NCS looking at what they referred to as blue-ocean endeavorsthose research and treatment areas that are under-investigated but which are high-priority because they cut across all of the disorders treated by neurocritical care experts.

It was very clear that the biggest problem we face in neurocritical care is the care of coma and DoC, he said. We deliberately framed the campaign as a grand challenge that would galvanize people across the field to come together and participate.

Dr. Hemphill said the Curing Coma Campaign is not restricted to researchers but actively solicits the participation of the entire community of clinicians, hospitals and health systemsas well as patients and familiesinvolved in neurocritical care. He noted that in September, the National Institutes of Health and the National Institute of Neurological Disorders and Stroke sponsored a two-day virtual symposium on neurocritical care of DOC. Additionally, NCS is sponsoring World Coma Day on March 22, 2021. He urged researchers, clinicians, and families to visit the Curing Coma Campaign website: https://www.curingcoma.org/home.

The campaign is also sponsoring a survey of clinicians involved in neurocritical carehttps://www.curingcoma.org/research/come-togetherdesigned to inform the coma scientific community about current prevailing concepts of coma and assess the spectrum of practice variability.

In order for the campaign to be successful, it requires a fundamental change in the understanding of coma, and for this, we need to leverage the wider community to participate, Dr. Hemphill told Neurology Today.

He said the ambitiousness of the campaign goals reflects an urgency felt by families and clinicians when a patient with DOC is in the neurocritical care unit: Will they wake up? Can they wake up? What can be done to help them wake up?

The gaps in understating of coma result often in a self-fulfilling prophesy of poor outcomes. There is probably not a single neurocritical care provider who doesn't have a dramatic story of a patient who they thought would never wake up, but after aggressive treatment recovered and did, he said. The problem is that currently, it is very challenging to identify at the time who those patients are going to be.

Experts who reviewed the paper for Neurology Today said the campaign is extraordinary in its visionand long overdue. We are not good at neuro-prognostication, said Gunjan Parikh, MD, associate medical director of the division of neurocritical care and emergency neurology at the University of Maryland.

Care withdrawal based on inadequate data persists, he said. Diagnostic error and misclassification of coma recovery potential in the ICU phase of care remain alarmingly high. Clinical consensus by the medical team after review of imprecise testing remains the primary means by which DoC diagnosis is made.

Dr. Parikh added that the agenda of the campaign is realistic and attainable but will require NCS to partner with public and private organizations already involved in the ongoing NIH BRAIN Initiative. Mapping the brain circuitry underlying consciousness is far more complex and open-ended than mapping the genome, he said. Localized neural circuits can involve one million cells in a complex, recursive network; however, consciousness is an emergent property of a more complex, distributed network of interconnected neural circuitry.

Shraddha Mainali, MD, assistant professor of clinical neurology at Ohio State University, said she believes the goal is ambitious, but not impossible. The authors have rightly pointed out the existing barriers in advancing coma science, she said.

Existing clinical classification of disorders of consciousness does not address distinctions based on underlying biological/pathophysiological mechanisms or functional/anatomical integrity of neural pathways necessary to maintain consciousness, Dr. Mainali added.

We lack biomarkers that can accurately assess severity, functional integrity and related connectivity (or lack thereof) of neural networks. Of the available tools to detect biomarkers, several are not easily available and are difficult to administer in the acute ICU setting. Such limitations in biomarkers and endotyping of individual patients have made it difficult to develop clinical trials in the acute phase of the disease.

Dr. Mainali added that there is wide variability in management, including practice regarding the withdrawal of care of patients with DOC, which accounts for a large proportion of deaths in this population.

The lack of precise biomarkers and prognostic models has led to such variability, as individual treating teams are obligated to come up with their own best estimate of disease severity and prognosis.

Dr. Parikh said a necessary first step is more widespread adoption of validated behavioral assessments in the acute phase. Sufficient behavioral sampling with serial examination after maximal arousal and accounting for all ICU confounders is paramount for progress, he said. Collaboration between intensivists, rehab specialists and physical therapists during the acute ICU phase is key for tracking the progress of arousal potential, whether in the neuro ICU, cardiothoracic ICU or medical ICU.

What are the implications for individual clinicians? A working understanding of bedside decision-support tools leveraging computational workflows that continuously improve coma recovery prediction models, based on real-time ICU data streams in individual patients, will become routine and a part of the competency assessment of future trainees, Dr. Parikh said.

Dr. Hemphill said he is hopeful that the complete net cast by the Curing Coma Campaign will ultimately make this moonshot successful. Some of the advances are going to be from scientific advances, but others from the community coming together and thinking about how to improve care right now with this patientbeing careful about prognostication and targeting aggressive therapies. Advances will also come from educating clinicians about the ability of patients to recover and families about what is and is not possible.

Drs. Hemphill, Parikh, and Mainali had no relevant disclosures.

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