NIH has created the NIH StrokeNet to conduct small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention, and recovery and rehabilitation following a stroke across the lifespan. This network of 27 regional centers across the U.S., which involves approximately 500 hospitals in the U.S., is designed to serve as the infrastructure and pipeline for exciting new potential treatments for patients with stroke and those at risk for stroke. The StrokeNet trials also collaborate with sites in other countries including Canada, Germany, United Kingdom, Spain, and Japan. In addition, NIH StrokeNet will provide an educational platform for stroke physicians, clinical trial coordinators and stroke researchers.
NINDS established the NIH StrokeNet to facilitate the development, promotion and conduct of high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment and recovery. An additional goal of the StrokeNet is to educate future stroke investigators and researchers in stroke prevention, treatment and recovery. The educational core provides webinars focused on stroke, research methodology and professional development. This network currently has a network of 27 regional coordinating centers, involves approximately 500 hospitals across the United States and is designed to serve as the infrastructure and pipeline for new potential treatments for patients with stroke and those at risk of stroke.
We are pleased to announce that the NINDS Clinical Trials Methodology Course (CTMC) is accepting applications for the 2022 cohort. The overarching goal of the CTMC is to help investigators develop scientifically rigorous, yet practical clinical trial protocols. Our focus is on investigators who have not previously designed their own prospective, interventional clinical trials.
There is a combination of distance learning activities and a REQUIRED residential course, along with small group mentorship from experienced clinical trialists and biostatisticians. The residential part of the course will be held July 18 – 21, 2022 in Iowa City, IA. Funding for travel (within the US) and accommodations will be provided for participants.
In large clinical trial conducted worldwide, full dose anti-coagulation (blood thinner) treatments given to moderately ill patients hospitalized for COVID-19 reduced the requirement of vital organ support—such as the need for ventilation. A trend in possible reduction of mortality was also observed and is being further studied. With large numbers of COVID-19 patients requiring hospitalization, these outcomes could also help reduce the overload on intensive care units around the world.
Early in the pandemic, physicians around the world observed increased rates of blood clots and inflammation among COVID-19 patients which affected multiple organs and led to complications such as lung failure, heart attack and stroke. Whether providing increased doses of blood thinners routinely administered to hospitalized patients would be safe and effective was unknown at that time.
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United
States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. F DA is committed to providing timely guidance to support continuity and response efforts to this pandemic.
FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
The primary concern for StrokeNet is the safety of our patients or potential patients for our ongoing trials. The second concern is the safety of our own investigators and study team members. Finally, we also want to maintain, as much as possible, the integrity of the trials to potentially benefit patients and so that the data can be used to answer the questions that the trials intended. This latter point is critical for subjects in the trial and those with the specific problem in the future.
However, immediate safety issues take priority over any formal processes in ongoing trials. For example, while a current protocol may specify that a study visit needs to be in person, the FDA has guidance about the primary safety of study subjects:
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The National Institute of Neurological Disorders and Stroke (NINDS), and National Institutes of Health (NIH) recently assembled an external working group of international experts to update the Stroke v1.0 Common Data Elements (CDEs) based on user feedback and research advances.
Nicole Dodds first noticed her son, Rowan, was having trouble using the right side of his body when he was about 6 months old. Babies typically use both hands to pick up toys and lift their chest off the floor at that age, but Rowan was mostly using his left arm and hand, keeping his right hand balled in a fist.
The Distinguished Clinical Research Achievement Awards are presented to the top two studies that show creativity, innovation, or a novel approach that demonstrates an immediate impact on the health and well-being of patients. This means we were ranked #2 or #3 among all clinical trials performed last year— includes all areas of medicine. The #1 award went to a study that reduced HTN by instituting therapy though a network of black barbershops
DEFUSE 3 results will be presented to selected members of Congress March 7th.
May 24, 2018 -
In-home rehabilitation, using a telehealth system and supervised by licensed occupational/physical therapists, is an effective means of improving arm motor status in stroke survivors, according to findings presented by University of California, Irvine neurologist Steven C. Cramer, MD, at the recent 2018 European Stroke Organisation Conference in Gothenburg, Sweden.
Advances in brain imaging can identify a greater number of stroke patients who can receive therapy later than previously believed, according to a new study co-led by researchers in NIH StrokeNet. The results of the "Endovascular Therapy Following Imaging Evaluation for the Ischemic Stroke (DEFUSE 3)” trial, presented at the International Stroke Conference 2018 in Los Angeles and published on Jan. 24 in the New England Journal of Medicine, demonstrated that physically removing brain clots up to 16 hours after symptom onset in selected patients led to improved outcomes compared to standard medical therapy. Click Full Story to see the published article:
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NIH StrokeNet Education “Pathophysiological Links between Migraine and Stroke”; Presented by Cenk Ayata, MD, Harvard Medical School, Massachusetts General Hospital NIH StrokeNet Education “Pathophysiological Links between Migraine and Stroke”; Presented by Cenk Ayata, MD, Harvard Medical School, Massachusetts General HospitalNIH StrokeNet Education “Pathophysiological Links between Migraine and Stroke.
Treatments for acute stroke include IV t-PA, stroke centers, stroke units, endovascular thrombectomy devices for selected patients, nimodipine for subarachnoid hemorrhage, and aneurysm coiling and clipping for ruptured aneurysms. Intracerebral hemorrhage has proven to be the most challenging for effective treatments; however recent research has shown promise
Despite the advances made in acute stroke care, stroke remains the leading cause of adult disability in Americans. World-wide there is an estimated 50 million stroke survivors coping with significant physical, cognitive and emotional deficits. The field of stroke recovery and restorative neuroscience is still young and provides a rich environment for innovative trials.