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Evaluation of Decision-Making Fatigue After Traumatic Brain Injury

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07103200
Acronym
EDIFY
Enrollment
40
Registered
2025-08-05
Start date
2025-09-24
Completion date
2029-07-15
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Keywords

Mild TBI, Decision-Making Fatigue

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.

Interventions

BEHAVIORALCOGED

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).

BEHAVIORALRestless 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.

Sponsors

University of Minnesota
Lead SponsorOTHER
Uniformed Services University of the Health Sciences
CollaboratorFED
United States Department of Defense
CollaboratorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Open-label preliminary, prospective cohort

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI4 yearsFeasibility 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.

Secondary

MeasureTime frameDescription
Acceptability of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI4 yearsAcceptability 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.

Countries

United States

Contacts

CONTACTResearch Coordinator
rnl@umn.edu612-873-7481
CONTACTDavid Darrow, MD, MPH
Darro015@umn.edu612-873-7481
PRINCIPAL_INVESTIGATORDavid Darrow, MD, MPH

Hennepin Healthcare Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026