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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after enrollment
Awards & highlights
MTAR Trial 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.Check my eligibility
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.See study design
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.
MTAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran with TBI and have cognitive issues affecting my daily life.
Select...
I am a veteran with no history of traumatic brain injury.
MTAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task
MTAR 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
1,609 Previous Clinical Trials
3,306,388 Total Patients Enrolled
Pratik Mukherjee, MD PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran with stable mental health conditions like depression or PTSD.I am a veteran over 18 with a TBI.I am a veteran with TBI and may have stable conditions like depression or PTSD.I am a veteran without traumatic brain injury and do not have psychosis.I am a veteran with TBI and do not have psychosis.I am a veteran over 6 months past my last concussion.I am a veteran with TBI and have cognitive issues affecting my daily life.I have been on stable psychoactive medication for over 30 days.I am 18 years old or older and a healthy veteran without traumatic brain injury.I am a veteran with no history of traumatic brain injury.I have been on the same psychoactive medication for more than 30 days.I am a veteran without any history of traumatic brain injury.I am a veteran with a history of moderate or severe traumatic brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Veteran Mild TBI Group - GOALS Intervention
- Group 2: Veteran Mild TBI - Treatment as Usual
- Group 3: Veteran Non TBI - No Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any opportunities to take part in this experiment?
"The trial in question on clinicaltrials.gov is no longer looking for participants, having been initialy posted back on March 9th 2017 and last updated October 6th 2022. However, 311 other trials are actively recruiting individuals at this time."
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