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Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for Emergency Department Patients With Glasgow Coma Scale 15 Traumatic Brain Injury (PIONEER-Prognosis)
Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * Diagnosis of mild traumatic brain injury (TBI), as defined by the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria. * Enrollment within 24 hours of injury. * Glasgow Coma Scale (GCS) score of 15 at emergency department (ED) enrollment. * Consent to study procedures, including: * Blood collection for biomarker measurement, including glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1). * Continuous use of a health-monitoring device for 3 months. * Follow-up assessments by telephone at 14 days and 90 days. * Completion of a daily symptom inventory via WHOOP/smartphone. Exclusion Criteria: * Pre-existing neurological disability or pre-injury condition that would have resulted in a Glasgow Outcome Scale-Extended (GOS-E) score \<8 if assessed before the injury. * High risk of loss to follow-up, including patients without a reliable phone, those experiencing homelessness, those who are incarcerated, or those who are wards of the state. * Pregnancy at the time of enrollment. * Inability to speak English or Spanish, which would prevent completion of the required assessments.
About the study
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.
Sponsor: University of Michigan · Participants: 500 · Started: Oct 20, 2026
Contact the study team
- Devon Newman, MS · Phone: 734-764-1602
Official record on ClinicalTrials.gov — NCT07858266
Locations in the U.S.
| California | Harbor-UCLA Medical Center, Torrance (Not yet recruiting) |
| Michigan | University of Michigan, Ann Arbor Henry Ford Macomb, Clinton Township Henry Ford Hospital, Detroit |
| Oregon | Oregon Health & Science University, Portland (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.