PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PIONEER-Prognosis study is a multicenter, prospective observational effort enrolling adults 18–65 with mild TBI and a GCS of 15 within 24 hours of injury. It applies the NINDS CBI-M framework, combining biomarker data (GFAP and UCH-L1), CT results, and psychosocial factors to predict long-term recovery. Participants wear a WHOOP device for 90 days and provide blood samples and clinical information at the ED, with follow-up assessments by phone at 14 and 90 days. The goal is to determine how well this integrated framework can forecast outcomes and inform clinical management after head injury.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Henry Ford Macomb
  Clinton Township, Michigan, United States Recruiting
• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• Harbor-UCLA Medical Center
  Torrance, California, United States Not yet recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Not yet recruiting

Study contacts

• Principal investigator: Frederick Korley, MD, PhD — University of Michigan
• Study coordinator: Devon Newman, MS
• Email: devonn@med.umich.edu
• Phone: 734-764-1602

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.