Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07103200

Evaluation of Decision-Making Fatigue After Traumatic Brain Injury

Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALCOGEDThe 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).
BEHAVIORALRestless BanditParticipants 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.

Timeline

Start date
2025-07-01
Primary completion
2029-07-15
Completion
2029-07-15
First posted
2025-08-05
Last updated
2025-08-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07103200. Inclusion in this directory is not an endorsement.