Evaluation of Decision-Making Fatigue After Traumatic Brain Injury

NCT07103200 | Recruiting

• 1 other identifier: IRB-FY2024-887
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Keywords

Mild TBI; Decision-Making Fatigue

Outcome Measures

Primary Outcomes (1)

• Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI

  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.

  4 years

Secondary Outcomes (1)

• Acceptability of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI

  4 years

Study Arms (2)

COGED

ACTIVE COMPARATOR

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: COGED

Restless Bandit

ACTIVE COMPARATOR

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.

Behavioral: Restless Bandit

Interventions

COGED BEHAVIORAL

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).

COGED

Restless Bandit BEHAVIORAL

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.

Restless Bandit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adults 18 years and older
• Able to perform a computerized assessment
• Willing to attend all scheduled appointments
• Able to undergo the informed consent process

Sponsors & Collaborators

• University of Minnesota: lead
• Uniformed Services University of the Health Sciences: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Darrow, MD, MPH

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

612-873-7481; rnl@umn.edu

David Darrow, MD, MPH

CONTACT

612-873-7481; Darro015@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label preliminary, prospective cohort

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)