Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07103200

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • None specified in the eligibility criteria

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

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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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