Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT07858266

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Study ID

NCT07858266

Start date

Oct 20, 2026

Status verified date

Oct, 2026

Completion date

Aug 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

GCS 15 TBI patients

Patients presenting to a study emergency department with a Glasgow Coma Scale (GCS) score of 15 and traumatic brain injury (TBI).

Primary outcome measure

  • Functional recovery [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Devon Newman, MS

734-764-1602devonn@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Devon Newman, MS

734-763-1702devonn@med.umich.edu

Principal Investigator:

Frederick Korley, MD, PhD

Henry Ford Macomb

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Kathleen Mays-Wilson

313-916-9551Kwilso10@hfhs.org

Principal Investigator:

Joseph Miller, MD, MS

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202 ·

Contacts

Kathleen Mays-Wilson

313-916-9551Kwilso10@hfhs.org

Principal Investigator:

Joseph Miller, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Nov 10, 2026

Last verified

Oct, 2026

Keywords

  • traumatic brain injury
  • prognosis
  • biomarker
  • wearable
  • gfap
  • uch-l1
  • GCS 15 TBI
  • whoop

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.