Improving cognitive function in veterans with mild brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on veterans with mild traumatic brain injury (mTBI) and aims to assess the effectiveness of a cognitive training program called Goal-Oriented Attentional Self-Regulation (GOALS). The program targets cognitive control processes such as attention, executive functions, and memory through personalized activities. Participants will undergo training and assessments, including functional MRI (fMRI) to evaluate changes in brain structure and function. The study seeks to determine both short and long-term benefits of the training on daily functioning and cognitive performance.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• San Francisco VA Medical Center, San Francisco, CA
  San Francisco, California, United States Completed

Study contacts

• Principal investigator: Pratik Mukherjee, MD PhD — San Francisco VA Medical Center, San Francisco, CA
• Study coordinator: Pratik Mukherjee, MD PhD
• Email: pratik.mukherjee@ucsf.edu
• Phone: (415) 353-9364

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.