Mild traumatic brain injury (TBI) and sport-related concussion (SRC) are major public health problems. Although significant advances have been made in our understanding of concussion, to date, the natural history of concussion remains poorly defined, no objective biomarker of physiological recovery exists for clinical use, and athlete knowledge of the injury remains low. This investigation is poised to address the true natural history of clinical and physiological recovery of SRC, which has critical implications for improving safety, injury prevention, and medical care in athletes and military personnel. Objective: In keeping with the identified priorities of the National Collegiate Atheletic Association (NCAA) and Department of Defense (DoD), we propose the Concussion Assessment, Research and Education (CARE) Consortium as a scientific and operational framework for the NCAA-DoD Grand Alliance. Hypotheses: There are two over-arching hypotheses driving this proposal:(1) Neurophysiological recovery from concussion extends beyond clinical signs and symptoms resolution.(2) A multidimensional combination of biomechanical, genetic, neuroradiological, biological, and clinical variables will be more strongly predictive of concussion risk and recovery than any single predictor variable. This study led by the Indiana University School of Medicine, Medical College of Wisconsin, and University of Michigan marks what is considered to be the most comprehensive investigation of sport-related concussion (SRC) ever conducted. This study will allow scientists to better understand the true natural history of concussion in athletes and investigate the correlation between multi-dimensional predictor and outcome variables associated with SRC from a fully neurobiopsychosocial perspective in a common injured sample and single study design.
AIM 1 Create a national multi-site consortium as a sustainable framework to achieve the clinical and scientific, priorities of the Concussion Research Initiative of the Grand Alliance. ADMINISTRATIVE AND OPERATIONS CORE (AOC): The AOC will serve as the centralized coordination center for the Longitudinal Clinical Study and Advanced Research Cores (CSC and ARC - see below), and Consortium members. Led by Thomas W. McAllister, M.D., chair of the IU School of Medicine, Department of Psychiatry, the AOC will provide fiduciary oversight for the CARE Coordinating Centers and provide Data and Analysis management, Bioinformatics, Biospecimen, and Clinical Trial Support (IRB/Regulatory coordination) resources. AIM 2 To conduct a prospective, longitudinal, multi-center, multi-sport investigation that delineates the natural history of concussion in both men and women by incorporating a multi-dimensional assessment of standardized clinical measures of post-concussive symptomatology, performance-based testing (cognitive function, postural stability), and psychological health. LONGITUDINAL CLINICAL STUDY CORE (CSC): The CSC will expand upon the existing NCAA National Sport Concussion Outcomes Study, a multi-site, longitudinal investigation of concussive and repetitive head impacts in NCAA student-athletes. The CSC will develop and implement a multi-year, multi-institution prospective, clinical longitudinal phase-in research protocol whose aim will be to study the natural history of concussion. The CSC will serve as the foundation upon which additional advanced research projects will be built The University of Michigan will lead the Longitudinal Clinical Study Core, a prospective, multi-institution clinical research protocol whose aim will be to study the natural history of concussion among NCAA student-athletes and be the largest ever of its type. Steven Broglio, Ph.D., ATC, associate professor in the School of Kinesiology and director of the NeuroSport Research Laboratory, will lead the effort. AIM 3 Utilize the framework of Aim 2 to conduct advanced scientific studies which integrate biomechanical, clinical, neuroimaging, neurobiological and genetic markers of injury to advance our understanding of neurophysiological effects and recovery after SRC in college athletes. ADVANCED RESEARCH CORE (ARC): The ARC will leverage existing collaborative research networks (e.g., NIH TRACK-TBI, DoD Project Head to Head, NFL-GE Head Health Challenge) to conduct advanced research projects that include, but are not limited to, impact sensor technologies, advanced neuroimaging, biological markers and comprehensive clinical studies to inform the neurobiopsychosocial understanding of SRC. Led by Dr. Michael McCrea, Professor of Neurosurgery and Director of Brain Injury Research at MCW, the ARC builds upon the CSC, thereby allowing for advanced research projects with the same foundational baseline and post-concussive clinical data. Ultimately, the work is designed to more fully inform a comprehensive understanding of sport-related concussion and traumatic brain injury.
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