Decision-Making Fatigue Assessment for Traumatic Brain Injury

(EDIFY Trial)

Overseen By David Darrow, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores decision-making and mental fatigue in individuals with mild to moderate traumatic brain injury (TBI) compared to those without. Researchers use two tasks, COGED and Restless Bandit, to examine differences in decisions and cognitive efforts between these groups. The trial seeks participants diagnosed with mild to moderate TBI who can complete computer-based tasks, as well as healthy individuals without TBI who can do the same. As an unphased trial, this study offers a unique opportunity to contribute to understanding TBI effects on decision-making and mental fatigue.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the COGED and Restless Bandit tasks are safe for participants?

Research has shown that both the COGED and Restless Bandit tasks are safe and noninvasive for participants. Although specific safety data for these tasks is not available, they are designed to assess thinking and decision-making skills without physical risk.

The COGED task involves memory and decision-making exercises, similar to puzzles or brain games, which are generally safe and well-tolerated.

The Restless Bandit task focuses on decision-making in changing situations, akin to a strategy game, and participants typically experience no negative effects.

Both tasks study brain function after a traumatic brain injury. Previous studies using similar methods have shown no evidence of harm. Overall, these tasks are safe and do not involve any physical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision-Making Fatigue Assessment for Traumatic Brain Injury trial because it explores unique methods to understand cognitive fatigue in patients. Unlike traditional treatments that often focus on medication or physical therapy, the COGED and Restless Bandit approaches dive into how decision-making and cognitive effort are affected. The COGED task uses working memory challenges to assess cognitive performance and effort cost, offering a new angle on understanding mental fatigue. Meanwhile, the Restless Bandit task encourages strategic decision-making, simulating real-life unpredictability and measuring adaptive responses. These innovative techniques could unveil new insights into the cognitive struggles faced by those with traumatic brain injuries.

What evidence suggests that the COGED and Restless Bandit tasks are effective for assessing decision-making fatigue in traumatic brain injury?

This trial will compare the COGED and Restless Bandit tasks for assessing and possibly improving thinking skills after a traumatic brain injury (TBI). Research has shown that the COGED task, which participants in this trial may perform, involves digital exercises that can enhance thinking abilities in TBI patients, including memory and decision-making. Meanwhile, the Restless Bandit task encourages participants to try out and choose between different options, aiding in understanding and possibly improving decision-making skills. This approach has succeeded in other areas and might help measure decision-making fatigue after TBI. Both tasks aim to provide insights into the thinking challenges faced by TBI patients and have the potential to support recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

David Darrow, MD, MPH

Principal Investigator

Hennepin Healthcare Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a mild to moderate traumatic brain injury (TBI) with a Glasgow Coma Scale score greater than 8. Participants must be able to perform computerized tasks and attend all appointments. They should also be capable of understanding the informed consent process.

Inclusion Criteria

* Adults 18 years and older

* Diagnosis of a mild to moderate TBI (GCS \> 8 on admission)

* Able to perform a computerized assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Phase Assessment

Participants undergo computerized assessments (COGED and Restless Bandit) to measure decision-making fatigue in the acute phase of recovery

1 visit

1 visit (in-person)

Subacute Phase Assessment

Participants undergo computerized assessments (COGED and Restless Bandit) to measure decision-making fatigue in the subacute phase of recovery

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for the acceptability and feasibility of the assessments over the study period

4 years

What Are the Treatments Tested in This Trial?

Interventions

• COGED
• Restless Bandit

Trial Overview The study is testing two tasks, COGED and Restless Bandit, to see if they are suitable for assessing decision-making fatigue in people who have suffered from mild to moderate TBI compared to healthy individuals.

How Is the Trial Designed?

Group I: Restless Bandit Active Control 1 Intervention

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 II: COGED Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330111/

Associations between cognitive and physical effort-based ... Specifically, participants with lower MAP scores, irrespective of group status, showed a stronger associations between task measures of cognitive and physical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7683428/

Effectiveness of Combining Compensatory Cognitive ... Effectiveness of combining compensatory cognitive training and vocational intervention vs. treatment as usual on return to work following mild-to-moderate ...

3. millisecond.com millisecond.com/download/library/cognitiveeffortdiscountingtask

Cognitive Effort Discounting Task (COGED) A procedure by Westbrook et al (2013) measuring the monetary value associated with cognitive effort. Duration: 20 minutes (Requires Inquisit Lab)

4. researchgate.net researchgate.net/figure/Cognitive-effort-discounting-COG-ED-paradigm-Task-structure-including-N-back-practice_fig5_253336056

Cognitive effort discounting (COG-ED) paradigm. Task ... Results: Our findings reveal that individuals with MDD exhibited significantly higher preferences for low-effort/low-reward options compared to their healthy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537419/

The effectiveness of digital cognitive intervention in patients ... This meta-analysis supports the efficacy of digital cognitive intervention in improving cognitive function in TBI patients. We recommend ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19940676/

Cognitive outcome following traumatic brain injury In adults, penetrating, moderate, and severe TBIs are associated with cognitive deficits 6 months or longer postinjury.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35173018/

Cognitive Outcome 1 Year After Mild Traumatic Brain Injury Poor 1-year cognitive outcome is common, affecting 13.5% of patients with mTBI vs 4.5% of controls. These results highlight the need for better understanding ...

8. msktc.org msktc.org/tbi/factsheets/cognitive-problems-after-traumatic-brain-injury

Cognitive Problems after Traumatic Brain Injury TBI can impact attention, concentration, information processing, and memory. Learn about cognitive problems and get tips on how to manage these challenges.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36964755/

Cognitive Outcome After Complicated Mild Traumatic Brain ... Complicated mTBI was associated with poorer cognitive outcomes than uncomplicated mTBI, but deficits were not comparable to those with moderate-severe TBI.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3927143/

Cognitive Sequelae of Traumatic Brain Injury - PMC In this paper we review the cognitive sequelae of closed head injury in adults, with a focus on deficits of executive function and everyday decision-making.