The NCAA-DoD Concussion Assessment, Research, and Education (CARE) Consortium

Study Description: Established in 2014, the U.S. Department of Defense (DoD) and the National Collegiate Athletic Association (NCAA) funded the Concussion Assessment, Research and Education (CARE) Consortium to inform science, clinical care and public policy related to concussion and repetitive head impact exposure (HIE) in U.S. Military Service Academy (MSA) cadets and collegiate student-athletes. The primary aims of the initial study were to: (1) establish a multisite research consortium to characterize the effects of concussion and repetitive head impact exposure on brain health, (2) characterize the clinical sequelae and natural history of concussion, (3) characterize the effect of concussion and repetitive head impacts on brain structure and brain function. The 30 member institutions of the CARE Consortium (26 civilian universities/colleges and 4 military service academies) agreed to invite all varsity athletes to undergo multimodal clinical assessments at preseason baseline, and at 5 additional timepoints after concussion diagnosis. At the service academies, non-varsity athlete cadets/midshipmen were also studied. Assessment Categories At Each Time Point Baseline: • Demographics • Personal and Family History • Neurocognitive Assessment • Neurological Status • Postural Stability • Symptoms ACUTE POST-INJURY FOLLOW-UP (CARE 1.0) (24 hrs; 48hrs; Asymptomatic; Unrestricted Return to Play (RTP); 6 mos) • Neurocognitive Assessment • Neurological Status • Postural Stability • Symptoms CUMULATIVE & PERSISTENT EFFECTS. (CARE 2.0) In-Person Exit Visit; Post-grad Online • Demographics • Personal and Family History • Neurocognitive Assessment • Neurological Status • Postural Stability • Symptoms • PROs • MROs (at academies only) LONG-TERM EFFECTS (CARE/SALTOS Integrated (CSI))Annual Online Assessment (at MSAs only); In-Person Research Visits • Demographics • Symptoms • Psychological health • PROs • MROs (at academies only)A subset of athletes at 6 of the CARE institutions underwent additional assessments including multimodal MRI, proteomic and genomic biomarker characterization, and head impact quantification (helmet-based sensors). Assessment time points for the ARC/pARC Neurocognitive and Behavioral Testing was done at Baseline, <48hrs Post-Injury, Cleared for Return to Play Progression (Asymptomatic), Unrestricted Return to Play, 7 days following Return to Play, and at >60 days after final game of junior year until end of collegiate career.Blood biomarker collection was done at Baseline, <48hrs Post-Injury, Cleared for Return to Play Progression (Asymptomatic), 7 days following Return to Play, and at >60 days after final game of junior year until end of collegiate career. Multi-modal MRI studies were done at Baseline, <48hrs Post-Injury, Cleared for Return to Play Progression (Asymptomatic), 7 days following Return to Play, and at >60 days after final game of junior year until end of collegiate career. However, please note that only athletes from one study performance site completed a multi-modal MRI study at baseline. ]]>
Inclusion: Enrollment: Varsity athlete in an NCAA recognized contact/collision sport, as well as cadets participating in rugby, wrestling, boxing, and combative training at the academies.Post-Injury Protocol: Injured Group: Meets study definition of concussion. For this study, concussion was defined using a consensus definition produced by a U.S. Department of Defense funded evidence based guidelines group (Carney, et al. 2014) and endorsed by the NCAA Concussion Management Guidelines 2014, which defines concussion as a change in brain function following a force to the head, which may be accompanied by temporary loss of consciousness, but is identified in awake individuals with measures of neurologic and cognitive dysfunction. Non-concussed Control Group: Matched to individual injured subjects based on gender, age, and sport.Exclusion: Enrollment: Clinically significant medical/neurological impairment Post-Injury Protocol: Any contraindication to MRI or blood biospecimen study procedures ]]>
Study History: The initial phase of CARE (“CARE 1.0”, 2014-2018) focused on the short-term outcomes (i.e. six-months) following concussion. The second phase of the study (“CARE 2.0”, 2018-2021) investigated the cumulative and persistent effects on brain health of concussion and repetitive head impact exposure over the course of a collegiate career and up to five years after graduation The third phase of CARE is known as the CARE/SALTOS Integrated (CSI) Study, or CARE/Service Academy Longitudinal mTBI Outcomes Study Integrated. This phase is investigating the nature and causes of long-term effects of head impact exposure and concussion/mild traumatic brain injury (mTBI) in former NCAA student-athletes and military service members. The CSI project will build upon existing CARE/SALTOS research by following former CARE participants beyond graduation to evaluate the long-term or late effects of HIE and/or concussion/mTBI for over 10 years or more after initial injury or exposure. ]]>