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Cognitive Rehabilitation for Traumatic Brain Injury

N/A
Waitlist Available
Led By Anthony J. W. Chen, MD MA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness)
age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-intervention, 3 months post-intervention
Awards & highlights

Study Summary

This trial will assess two different approaches to brain injury rehabilitation delivered remotely via tele-rehabilitation, with the goal of helping Veterans build personal strengths and better accomplish their goals.

Who is the study for?
This trial is for post-9/11 Veterans aged 21-60 who have had a mild to moderate traumatic brain injury and are at least six months into recovery. They should experience cognitive symptoms like memory issues and be interested in goal-setting and training. It's not suitable for those with severe mental health conditions, other neurological disorders, or ongoing medical issues that could affect participation.Check my eligibility
What is being tested?
The study tests two remote rehabilitation methods delivered via tele-rehabilitation supported by digital apps: BrainStrong-OPT and BrainStrong-GSR. These interventions aim to help Veterans improve attention regulation, memory retention, and emotional control to achieve their life goals.See study design
What are the potential side effects?
Since the interventions involve cognitive training exercises rather than medications, traditional side effects are not expected. However, participants may experience fatigue or frustration during intensive training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a mild to moderate traumatic brain injury.
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I am between 21 and 60 years old and have had a mild to moderate traumatic brain injury.
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I am over 6 months post-injury, have memory issues, and am open to intensive training.
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I experience trouble with my memory or concentration.
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I am between 21 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-intervention, 3 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post-intervention, 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Selective Information Processing
Secondary outcome measures
Observed Functional performance
Progress Towards Goal Attainment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BrainStrong-GSRExperimental Treatment1 Intervention
Goal-directed State Regulation Training (GSR)
Group II: BrainStrong-OPTActive Control1 Intervention
Optimization of Brain Functioning (OPT)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,476 Total Patients Enrolled
Anthony J. W. Chen, MD MAPrincipal InvestigatorVA Northern California Health Care System, Mather, CA

Media Library

BrainStrong-GSR Clinical Trial Eligibility Overview. Trial Name: NCT04109027 — N/A
Cognitive Impairment Research Study Groups: BrainStrong-OPT, BrainStrong-GSR
Cognitive Impairment Clinical Trial 2023: BrainStrong-GSR Highlights & Side Effects. Trial Name: NCT04109027 — N/A
BrainStrong-GSR 2023 Treatment Timeline for Medical Study. Trial Name: NCT04109027 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still any opportunities for patients to join this research endeavor?

"The information currently available on clinicaltrials.gov indicates that this study is no longer recruiting participants. Initially posted during May 10th 2023 and edited lastly back in October 21st 2022, the trial has already concluded its recruitment process; however, there are 569 other medical trials actively seeking candidates at present."

Answered by AI

Is this research endeavor open to individuals older than fifty-five?

"Patients eligible for this medical trial must be older than 21 but below the age of 60."

Answered by AI

Is my profile suitable for inclusion in this medical experiment?

"The trial is accepting 120 patients between the ages of 21 and 60 who have experienced cognitive deterioration. To qualify, they must be Post 9/11 Veterans with mild-moderate traumatic brain injury (including evidence of head trauma or loss of consciousness) that occurred at least 6 months ago as well as one self-reported symptom related to working memory difficulty. Additionally, participants need a strong interest in goal setting and intensive training."

Answered by AI
~80 spots leftby Mar 2026