DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

THE NCAA-DOD GRAND ALLIANCE: Concussion Assessment, Research, and Education Consortium (CARE)

Principal Investigator: MCALLISTER, THOMAS W
Institution Receiving Award: INDIANA UNIVERSITY, INDIANAPOLIS
Program: PH-TBI
Proposal Number: 14132004
Award Number: W81XWH-14-2-0151
Funding Mechanism: Broad Agency Announcement
Partnering Awards:
Award Amount: $19,635,999.00


TECHNICAL ABSTRACT

Background: 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.

Specific Aims: Our specific aims are as follows:

Aim 1: Create a national multi-site consortium as a sustainable framework to achieve the clinical and scientific, priorities of the NCAA-DoD Grand Alliance Concussion Research Initiative.

Aim 2: Conduct a prospective, longitudinal, multi-site, multi-sport investigation that delineates the natural history of concussion in males and females by incorporating a multi-dimensional assessment of standardized clinical measures of post-concussive symptomatology, performance-based testing (e.g., cognitive function, postural stability), and psychological health.

Aim 3: Utilize the framework of Aim 2 to conduct advanced scientific studies that integrate biomechanical, clinical, neuroimaging, neurobiological, and genetic markers of injury to advance our understanding of neurophysiological effects and recovery after SRC in college athletes.

Research Approach and Methods: The CARE Consortium is designed around the following core functions and scientific investigations:

Administrative and Operations Core (AOC): The AOC will serve as the centralized coordination center for the Longitudinal Clinical Study Core (CSC) and Advanced Research Core (ARC) Consortium members providing administrative and fiduciary oversight, support for data collection and management, biobanking, and bioinformatics and biostatistics.

Longitudinal Clinical Study Core: The CSC will expand upon our existing multi-site, longitudinal investigation (NCAA National Sport Concussion Outcomes Study) 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 advanced research projects will be built.

Advanced Research Core: 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 intervention studies and testing to inform the neurobiopsychosocial understanding of SRC. The ARC will build upon the CSC, thereby allowing for a number of advanced research projects with the same foundational clinical baseline and post-concussive data.

Military Relevance: The NCAA-DoD Grand Alliance will be the most comprehensive investigation of concussion and head impact exposure ever conducted, and represents an unprecedented opportunity to advance the field of concussion science. The aims of this proposal align directly with the DoD's priorities to develop evidence-based approaches to improving the medical care, health and welfare of our military service members affected by TBI. This project also has the potential to positively impact the medical care of concussed athletes at all levels, including high school and youth participants.