This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.
The PIONEER Prognosis Study is a prospective, multicenter, observational cohort study of adults aged 18 to 65 years who present to the emergency department within 24 hours of a mild traumatic brain injury (TBI) and have a Glasgow Coma Scale score of 15, meaning they are fully alert. Although these injuries are classified as mild, up to half of such patients report persistent symptoms such as headaches, cognitive difficulties, and mood disturbances a year after injury, and clinicians currently lack a reliable way to predict at the time of the emergency department visit which patients will recover fully and which will not. This study will apply a new classification framework proposed by the National Institute of Neurological Disorders and Stroke, called CBI-M (Clinical, Biomarker, Imaging, and Modifiers), which combines clinical findings, a blood test for two brain injury proteins (GFAP and UCH-L1), results of any head CT scan performed as part of routine care, and psychosocial and environmental factors, and will evaluate how well this framework predicts recovery. A total of 500 participants will be enrolled from five emergency departments in Michigan, Oregon, and California that already use the GFAP and UCH-L1 blood test in clinical care. Participants will provide a blood sample and clinical information during their emergency department visit, wear a WHOOP wearable device continuously for 90 days to record heart rate, heart rate variability, sleep, and physical activity, complete a brief daily symptom survey through the device application, and complete additional symptom and sleep questionnaires by email or phone at 1 week, 1 month, and 2 months. Trained interviewers from a central outcomes team will contact participants by telephone at 14 and 90 days to assess functional recovery using the Glasgow Outcome Scale-Extended, along with symptoms, cognition, life satisfaction, post-traumatic stress symptoms, and resilience. The primary outcome is complete functional recovery, defined as a Glasgow Outcome Scale-Extended score of 8 at 90 days. The study does not assign any treatment; participants receive standard emergency department care. Findings are intended to improve prognostic accuracy, patient counseling, and follow-up care for the largest subgroup of TBI patients, and the prediction models developed will be made available as a free web-based tool. The study is funded by the U.S. Department of Defense and is expected to take approximately 4 years to complete, with each participant followed for 3 months.