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GOALS Training + Brain Health Education for Traumatic Brain Injury (MTAR Trial)

N/A
Recruiting
Led By Pratik Mukherjee, MD PhD
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
For TBI-positive veteran participants to be randomized to either GOALS or TAU: Report of residual cognitive difficulties that interfere with daily function
For the TBI-negative healthy veteran control group: No history of any TBI
Must not have
For the TBI-negative healthy veteran control group: Psychosis
For TBI-positive veteran participants to be randomized to either GOALS or TAU: Psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after enrollment
Awards & highlights

Summary

This trial will test whether training in self-regulation can help improve daily life for veterans with mild traumatic brain injury (TBI) and comorbid conditions. The study will also look at how these benefits relate to changes in cognitive and behavioral performance and brain networks.

Who is the study for?
This trial is for Veterans aged 18+ with mild TBI who've been stable post-concussion for over 6 months and can commit to training and assessments. It's also open to healthy Veterans without TBI history, able to participate in assessments. Excluded are those with severe mental health issues, poor English skills, ongoing substance abuse, or conditions preventing study participation.
What is being tested?
The trial tests if Goal-Oriented Attentional Self-Regulation (GOALS) improves daily life functioning in Veterans with mild TBI compared to standard Brain Health Education (BHE). The effectiveness will be measured through cognitive/behavioral performance changes and fMRI scans of brain networks.
What are the potential side effects?
Since the interventions involve behavioral therapy and education rather than medication, traditional side effects are not expected. However, participants may experience fatigue or emotional discomfort during the cognitive tasks or from discussing personal experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran with TBI and have cognitive issues affecting my daily life.
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I am a veteran with no history of traumatic brain injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a veteran without traumatic brain injury and do not have psychosis.
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I am a veteran with TBI and do not have psychosis.
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I am a veteran without any history of traumatic brain injury.
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I am a veteran with a history of moderate or severe traumatic brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Veteran Mild TBI Group - GOALS InterventionExperimental Treatment2 Interventions
Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
Group II: Veteran Mild TBI - Treatment as UsualActive Control2 Interventions
Veterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care.
Group III: Veteran Non TBI - No TreatmentActive Control1 Intervention
Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fMRI
2019
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,005 Total Patients Enrolled
Pratik Mukherjee, MD PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA

Media Library

Goal-Oriented Attentional Self-Regulation (GOALS) Clinical Trial Eligibility Overview. Trial Name: NCT02920788 — N/A
Traumatic Brain Injury Research Study Groups: Veteran Mild TBI Group - GOALS Intervention, Veteran Mild TBI - Treatment as Usual, Veteran Non TBI - No Treatment
Traumatic Brain Injury Clinical Trial 2023: Goal-Oriented Attentional Self-Regulation (GOALS) Highlights & Side Effects. Trial Name: NCT02920788 — N/A
Goal-Oriented Attentional Self-Regulation (GOALS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02920788 — N/A
~5 spots leftby May 2025
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