Evaluation of Decision-Making Fatigue After Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COGED, Restless Bandit.
- Who it may be relevant to
- Registry conditions: TBI (Traumatic Brain Injury). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)
Overview
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
- Behavioral 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 cogniti - 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 Rest
Primary outcome measures
- Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI [Time frame: 4 years]
Secondary outcome measures (1)
- Acceptability of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT07103200 · IRB-FY2024-887