Next phase of CARE, the CARE-SALTOS Integrated (CSI) Study to follow athletes 10+ years after concussive injury and repetitive head impact exposure

The NCAA-U.S. Department of Defense Concussion Assessment, Research and Education (CARE) Consortium — the largest concussion and repetitive head impact study in history — has received a $42.65 million award to launch the next phase of the landmark research project that is co-led by the University of Michigan.

The U.S. Army Medical Research and Development Command (USAMRDC) awarded $25 million to CARE, with an additional $10 million coming from the NCAA and $7.65 million from the Defense Health Agency.

CARE is the product of the historic NCAA-DOD in 2014, and the next phase, known as CARE/Service Academy Longitudinal mTBI Outcomes Study (SALTOS) Integrated (CSI) Study, will investigate the long-term effects of head impact exposure (HIE) and concussion/mild traumatic brain injury in NCAA student-athletes and military service members.

The University of Michigan leads the longitudinal clinical study core, a prospective, multi-institution clinical research protocol. Dr. Steven Broglio, professor of kinesiology and director of the U-M Concussion Center at Michigan, is a co-PI of the CSI award.  U-M is joined by Indiana University School of Medicine, the Medical College of Wisconsin, and the Uniformed Services University of the Health Sciences as core leaders along with over 30 other institutions.

“The University of Michigan has played a crucial role in the initial phases of the CARE Consortium by addressing previously unanswered questions on the natural history of concussion across a diverse set of athletes and military service members.  The current funding will allow us to begin rigorous inquiry of the long term effects of concussion in those same athletes and service members,” said Broglio.

The initial phase of CARE focused on the six-month natural history and neurobiology of acute concussion and HIE. The second phase, CARE 2.0, prospectively investigated the intermediate effects — such as changes in brain health outcomes over a college career — and early persistent health effects associated with HIE and concussion soon after graduation. The latest awards bring the total Grand Alliance funding now to over $105 million.

The CSI investigative team will build upon existing CARE/SALTOS research by following former CARE research participants beyond graduation to evaluate the long-term or late effects of HIE and/or concussion/mTBI for up to 10 years or more after initial exposure or injury.

“Identifying the neurobiological pathways that possibly contribute to long-term negative consequences of concussion and repetitive head impacts is critical for the development of early interventions and strategies in athletes and service academies who are at risk,” said NCAA Chief Medical Officer Dr. Brian Hainline. “We are confident this award from MTEC, coupled with additional funding from the NCAA and DOD, will provide us the support to develop an array of interventions that mitigate possible long-term effects of concussion or HIE.”

The most comprehensive, prospective study of its kind to better understand concussion, HIE and effects on brain health, the CARE Consortium is funded by the NCAA and U.S. Department of Defense with broad aims to enhance the health and safety of NCAA student-athletes and military service members. It also serves as a valuable resource for youth sports participants and society at large. It is also the first major concussion study to assess both women and men in 24 sports; prior to CARE, most concussion literature came from men’s football and men’s ice hockey.

The CARE Consortium is overseen by principal investigators at research institutions across the country. Leveraging its extensive infrastructure and experienced research team, CARE has published over 80 scientific papers that are critical to advancing the science of mTBI/concussion and HIE.

With the MTEC/DOD award, combined with additional funding from the NCAA, CSI is now well-positioned to investigate the brain health of NCAA athletes and military service members who have had concussion or HIE, compared to those who have had neither. Additionally, the effects of other medical conditions on brain health will be assessed in military service members.

An integrated public/private effort, CSI is designed to identify the unique individual characteristics (such as phenotypes/genotypes) of individuals at a higher versus lower risk of negative outcomes associated with concussion and HIE. This dataset will be made available to the broader scientific community to promote further development of specific strategies for injury prevention, early recognition, and mitigating treatments of those at greatest risk of brain health effects.