Predicting recovery after a mild head injury using blood tests and wearables
Studies how blood tests and wearable devices can predict recovery after concussion.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Ann Arbor, Clinton Township, Detroit, Portland, and Torrance, United StatesSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07858266, who can take part
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Henry Ford MacombClinton Township, United StatesTaking people
- Henry Ford HospitalDetroit, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesNot yet recruiting
- Harbor-UCLA Medical CenterTorrance, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Michigan
- Trial code
- NCT07858266
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
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.
Inclusion: 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: 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.