Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseobservationalRules rewrite

Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging,…

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.

Official registry: https://clinicaltrials.gov/study/NCT07858266 · University of Michigan · enrollment listed as 500

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 500 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)

Primary outcome (registry wording): Functional recovery

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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

Public study contact (from the registry)

Devon Newman, MS

734-764-1602

devonn@med.umich.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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FAQ about this NCT record

Is NCT07858266 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07858266?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07858266?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary