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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);
Must not have
Active psychotropic medication changes
Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-intervention, 3 months post-intervention
Awards & highlights
No Placebo-Only Group

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.
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.
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 experience trouble with my memory or concentration.
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I am between 21 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My mental health medication has recently changed.
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I am unable or unwilling to participate in training due to severe lack of motivation or speech issues.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,664 Previous Clinical Trials
3,765,668 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-GSR, BrainStrong-OPT
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
~80 spots leftby Mar 2026
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