The 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. This network of 25 regional centers across the U.S., which involves more than 200 hospitals, is designed to serve as the infrastructure and pipeline for exciting new potential treatments for patients with stroke and those at risk for stroke. In addition, NIH StrokeNet will provide an educational platform for stroke physicians and clinical trial coordinators.
In September 2013, the National Institutes of Health funded the stroke trials network, NIH StrokeNet. The StrokeNet infrastructure consists of 25 regional coordinating centers across the US, a national coordinating center at the University of Cincinnati, and a national data management center (Medical University of South Carolina). The primary goal of this network is to maximize efficiencies to develop, promote and conduct high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment and recovery.
The 2020 Biomedical Data Science Innovation Lab is an intensive residential workshop to foster the development of early-career (post-doc, assistant to early associate professor) biomedical investigator and quantitative investigator (i.e. data scientists, computer scientists, biostatisticians) teams. This facilitated and mentored workshop will tackle data science challenges arising from the use of large-scale neuroscience related data. We are asking all NIH-NCATS Clinical and Translational Science Award (CTSA) Directors to nominate two (2) distinct early-career investigators from a) the biomedical fields specifically including human neuroscience and b) the quantitative and data science disciplines to apply.
he NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.
This is a rapidly evolving situation and we will provide updated guidance and information as it becomes available. See Full Story.
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:
NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)
This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure.
NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44)
This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects.
NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke
Treatment, Recovery, and Prevention Infrastructure Resource
This FOA encourages requests for access to research resources for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will be given access to the NIH StrokeNet infrastructure.
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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.