Mild TBI Assessment & Rehabilitation

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT02920788
Status
Recruiting
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Conditions

  • Brain Injuries, Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Goal-Oriented Attentional Self-Regulation (GOALS) — BEHAVIORAL
    GOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.
  • Brain Health Education (BHE) — OTHER
    BHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain.
  • fMRI — DEVICE
    Functional Magnetic Resonance Imaging of the Brain

Study Details

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

Key Dates

Start date
Mar 9, 2017
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Apr 13, 2027

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Veteran Mild TBI Group - GOALS Intervention
    Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
  • Active Comparator: Veteran Mild TBI - Treatment as Usual
    Veterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care.
  • No Intervention: Veteran Non TBI - No Treatment
    Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention.

Primary Outcome Measure

Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task [ Time Frame: 6 months after enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563-
University of California, San FranciscoSan FranciscoCalifornia94158
Pratik Mukherjee, MD
[email protected]
415-353-8972
Tatjana Novakovic-Agopian
[email protected]
4157533888

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By research site
San Francisco VA Medical Center, San Francisco, CA· San Francisco, CAUniversity of California, San Francisco· San Francisco, CA

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