Improving cognitive function in veterans with mild brain injuries

Multi-Level Assessment and Rehabilitation of Combat Mild TBI

This study is testing a new brain training program for veterans with mild brain injuries to see if it can help improve their attention, memory, and everyday functioning.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Locations: 2 sites (San Francisco, California and 1 other locations)
• Trial ID: NCT02920788 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include veterans aged 18 and older with a history of mild TBI and ongoing cognitive difficulties.

Not a fit: Patients without a history of TBI or those who are not experiencing cognitive difficulties may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive and emotional functioning for veterans suffering from mild TBI.

How similar studies have performed: Previous studies using similar cognitive training approaches have shown promising results in improving cognitive performance in individuals with chronic brain injuries.

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

Where this trial is running

San Francisco, California and 1 other locations

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (COMPLETED)
• University of California, San Francisco — San Francisco, California, United States (RECRUITING)

Study contacts

• Principal investigator: Pratik Mukherjee, MD PhD — San Francisco VA Medical Center, San Francisco, CA
• Study coordinator: Pratik Mukherjee, MD PhD

Conditions: Brain Injuries, Traumatic, Rehabilitation, Functional Magnetic Resonance Imaging