Evaluation of Decision-Making Fatigue After Traumatic Brain Injury

NCT ID: NCT07103200

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-07-15

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.

Detailed Description

This study aims to measure the effects of traumatic brain injury in the acute and subacute phases of recovery using these two noninvasive computerized assessments (COGED and bandit). All participants engaged in the study will participate in a total of three visits at Hennepin Healthcare Systems, Inc. (HHS). Each visit will consist of surveys and computerized assessments that will help researchers to understand the effects of decision-making on mental fatigue.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

COGED

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Restless Bandit

Intervention Type: 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.

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Darrow, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Research Coordinator

Role: CONTACT

rnl@umn.edu

612-873-7481

David Darrow, MD, MPH

Role: CONTACT

Darro015@umn.edu

612-873-7481

Facility Contacts

Research Coordinator

Role: primary

rnl@umn.edu

612-873-7481

Other Identifiers

IRB-FY2024-887

Identifier Type: -

Identifier Source: org_study_id