Decision-making fatigue after a traumatic brain injury
Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07103200 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.