Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Decision-making fatigue after a traumatic brain injury

Official title: Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)

Run by University of Minnesota · NCT07103200 · Data updated 2026-11-12

This project will try two short computer tasks (COGED and the Restless Bandit) to see if they can detect decision-making fatigue in adults with mild to moderate traumatic brain injury and in healthy adults.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorUniversity of Minnesota
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedSeptember 24, 2025
Main results expectedJuly 15, 2029
Study endsJuly 15, 2029
Registry record updatedAugust 5, 2026
Trial IDNCT07103200 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (18+) who can give consent, are willing to attend three clinic visits, can use a computer for testing, and either have a documented mild-to-moderate TBI (GCS > 8 on admission) or are healthy controls.

Probably not a fit

People with severe TBI, those unable to complete computerized assessments, those under 18, or those unable to attend the scheduled visits are unlikely to benefit from this study's results.

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

What this trial studies

This is a prospective cohort feasibility study that enrolls adults with mild to moderate TBI and healthy control volunteers. Each participant completes three in-person visits at Hennepin Healthcare/University of Minnesota locations during the acute and subacute recovery windows. At each visit participants complete surveys and two computerized tasks (COGED and the Restless Bandit) that probe decision-making and mental fatigue. Data will compare task performance over time between TBI and control groups to determine feasibility and signal for decision-making fatigue.

Why it matters

Potential benefit: If successful, the tasks could offer a simple, noninvasive way to detect decision-making fatigue and help guide timing or focus of rehabilitation after TBI.

How similar studies have gone: Related computerized decision-making tasks have been used in cognitive research, but applying COGED and the Restless Bandit specifically to detect decision-making fatigue after TBI is preliminary and relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria for TBI Participants:

* Adults 18 years and older
* Diagnosis of a mild to moderate TBI (GCS \> 8 on admission)
* Able to perform a computerized assessment
* Willing to attend all scheduled appointments
* Able to undergo the informed consent process

Inclusion Criteria for Healthy Participants:

* Adults 18 years and older
* Able to perform a computerized assessment
* Willing to attend all scheduled appointments
* Able to undergo the informed consent process

Where it's running

  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: David Darrow, MD, MPH — Hennepin Healthcare Research Institute
  • Study coordinator: Research Coordinator
  • Email: rnl@umn.edu
  • Phone: 612-873-7481

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.