NCT07103200 · University of Minnesota
Evaluation of Decision-Making Fatigue After Traumatic Brain Injury
(EDIFY)
What this study is about
This is a preliminary, forward-looking, group of participants study to investigate the feasibility of using the COGED and Restless Bandit tasks after a mild to moderate traumatic brain injury as well as in healthy controls.
View original scientific description
This is a preliminary, prospective, cohort study to investigate the feasibility of using the COGED and Restless Bandit tasks after a mild to moderate traumatic brain injury as well as in healthy controls.
Interventions
BEHAVIORAL
COGED
The COGED task consists of the classic N-back task of working memory-based decision making, followed by a valuation phase. The N-back phase of the task allows calculation of cognitive performance of a working memory task. During valuation, participants receive titrating offers of differing amounts of money to perform different difficulty levels of the N-back. The result is an effort discounting curve used to measure the individual effort cost. Effort discounting curves show the perceived cognitive effort required to complete each level of the task relative to another (typically the 1-back).
BEHAVIORAL
Restless Bandit
Participants are presented with three targets (decks of cards) on the screen, which they select with a mouse movement. Each of the three targets is associated with a hidden probability of reward, which drifts unpredictably and independently across trials. This encourages participants to "exploit" good options when they are available, but also occasionally to "explore "other targets, which could become better at any time. Eye Tracking is done at each visit while the participant completes the Restless Bandit tasks.
Primary outcome measures
Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI
Time frame: 4 years
Feasibility will be calculated using the sum total number of patients who completed at least 80% of study procedures divided by the sum total number of patients, which is a proportion ranging from 0 to 1. We will then determine if that exceeds 0.5, with higher numbers indicating more feasible.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Collaborators
Uniformed Services University of the Health Sciences, United States Department of Defense
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2025 · Source of record for eligibility and locations