Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT07103200

Conditions

TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

COGED

Restless Bandit

Study Details

Brief summary:

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.

Conditions

TBI (Traumatic Brain Injury)

Study ID

NCT07103200

Start date

Sep 24, 2025

Status verified date

Aug, 2026

Completion date

Jul 15, 2029

Anticipated

Primary completion date

Jul 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: 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).

active comparator: 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.

Interventions

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).

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 measure

  • Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Research Coordinator

612-873-7481rnl@umn.edu

David Darrow, MD, MPH

612-873-7481Darro015@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Research Coordinator

612-873-7481rnl@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Mild TBI
  • Decision-Making Fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.