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Mild TBI Assessment & Rehabilitation
Multi-Level Assessment and Rehabilitation of Combat Mild TBI
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: For TBI-positive veteran participants, to be randomized to either GOALS or TAU: * Ages 18+ * A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument) * Chronic, stable phase of recovery (\>6 months from last post-concussive event) * Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function * Able and willing to commit to participate in training and assessments * If on psychoactive medications, must be stable on medications (\> 30 days) For the TBI-negative healthy veteran control group: * Ages 18+ * No history of any (mild to severe) TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument) * Able and willing to commit to participate in assessments * If on psychoactive medications, must be stable on medications (\> 30 days) Exclusion Criteria: For the TBI-positive veteran participants, to be randomized to either GOALS or TAU: * A history of moderate or severe TBI * Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI) * Ongoing illicit drug or alcohol abuse (AUDIT\>8) * Psychosis * Severe depression, anxiety or PTSD that precludes participation in research activities * Poor English comprehension * Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD * There will be no restriction in regard to gender, race and socioeconomic status For the TBI-negative healthy veteran control group: * A history of any mild, moderate, or severe TBI * Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI) * Ongoing illicit drug or alcohol abuse (AUDIT\>8) * Psychosis * Severe depression, anxiety or PTSD that precludes participation in research activities * Poor English comprehension * Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD. * There will be no restriction in regard to gender, race and socioeconomic status
About the study
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.
What is being tested
- Goal-Oriented Attentional Self-Regulation (GOALS) (behavioral)
- Brain Health Education (BHE) (other)
- fMRI (device)
Sponsor: VA Office of Research and Development · Participants: 65 · Started: Mar 9, 2017
Contact the study team
- Pratik Mukherjee, MD PhD · Phone: (415) 353-9364
Official record on ClinicalTrials.gov — NCT02920788
Locations in the U.S.
| California | University of California, San Francisco, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.