Actively Recruiting
Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)
Led by University of Minnesota · Updated on 2025-08-05
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
U
Uniformed Services University of the Health Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating decision-making fatigue following mild to moderate traumatic brain injury (TBI) using two computerized tasks, COGED and the Restless Bandit, in both TBI patients and healthy controls. The study aims to measure the effects of TBI during the acute and subacute recovery phases, focusing on how decision-making impacts mental fatigue. This is a preliminary, prospective cohort study without randomization or masking. Participants will complete three visits, each involving surveys and the computerized assessments at Hennepin Healthcare Systems. The COGED task includes an N-back working memory challenge followed by a valuation phase where participants receive varying monetary offers to perform tasks of different difficulties, generating an effort discounting curve that reflects perceived effort. The Restless Bandit task involves selecting among three card decks with changing reward probabilities to encourage exploration and exploitation strategies, while eye tracking is performed during this task. During each visit, participants undergo surveys, computerized tasks, and eye tracking to assess decision-making fatigue. Researchers will evaluate the feasibility and acceptability of using these assessments over a four-year period. The total participation involves three visits, with ongoing monitoring of cognitive effort and mental fatigue effects. This study includes both individuals with mild to moderate TBI and healthy volunteers aged 18 and older.
CONDITIONS
Brief Title
Evaluation of Decision-Making Fatigue After Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Diagnosis of a mild to moderate traumatic brain injury with Glasgow Coma Scale above 8 on admission
- Able to perform computerized assessments
- Willing to attend all scheduled study visits
- Able to give informed consent
- Healthy adults 18 years and older able to perform computerized assessments and willing to attend all visits
You will not qualify if you...
- None specified in the eligibility criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Over the course of the study with three visits
Participants complete computerized assessments and surveys at each visit to measure decision-making fatigue after traumatic brain injury.
3 visits (in-person)
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
R
Research Coordinator
D
David Darrow, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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