Evaluation of Decision-Making Fatigue After Traumatic Brain Injury

ConditionTBI (Traumatic Brain Injury)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: COGEDActive comparator 1 intervention

Group B: Restless BanditActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

4 years

Secondary outcomes

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

Acceptability will be calculated using the sum total number of patients who liked 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 acceptable.

Time frame

4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Uniformed Services University of the Health Sciences

Collaborator

United States Department of Defense