The NCAA and DOD launched a 3-yr, $30 million concussion study aimed at increasing the understanding of the natural history of concussion and enhancing the safety of NCAA student-athletes and military service members. The study is co-chaired by principal investigators at three research institutions: Indiana University (Thomas McAllister, MD), University of Michigan (Steven Broglio, PhD, ATC), and Medical College of Wisconsin (Michael McCrea, PhD). The study includes two research arms, the Longitudinal Clinical Study Core (CSC) led by Dr. Broglio and the Advanced Research Core (ARC) led by Dr. McCrea. IU School of Medicine is serving as the Administrative Coordinating Center. Datalys Center is working closely with the Data Management and Biostatistics Team led by Dr. Barry Katz to manage data collection and analysis. Datalys Center is responsible for the development and launch of an electronic data capture system for all CSC and ARC CARE data and work closely with QuesGen Systems, Inc. -- a company that develops data capture platforms for traumatic brain injury and other clinical research. The Care Electronic Data Capture System was successfully launched on December 11, 2014, and an accompanying Participant Portal, allowing for athletes to electronically enter baseline data, was launched May 2015. These de-identified data are submitted quarterly to the Federal Institute for Traumatic Brain Injury Registry (FITBIR).
The objective of the longitudinal CSC is to study the natural history of concussion among NCAA-student athletes. The goal of the ARC is to study the acute effects and early patterns of recovery from sport-related concussions using advanced imaging, biomarker, and head impact technologies. The consortium currently consists of 30 NCAA institutions and military academies, 6 of those participating in CSC and ARC, which are providing baseline data on all (consented) student athletes and post-injury data on concussed athletes. Post-injury data are collected at multiple time-points: <6 hours post-injury evaluation, 24-48 hours post-injury evaluation, daily symptom evaluations until the athlete is asymptomatic, asymptomatic evaluation, return to play evaluation and a 6-month evaluation. Assessments completed at the various time points include self-reported concussion symptoms (SCAT3 Symptom Evaluation, Behavioral Symptom Inventory-18), a balance assessment (Balance Error Scoring System), neurological status assessment (Standardized Assessment of Concussion) and Neurocognitive Assessment (e.g., ImPACT, CNS Vital Signs, etc.). Ultimately, the work is designed to more fully inform a comprehensive understanding of sport-related concussion and traumatic brain injury.