Mild TBI Assessment & Rehabilitation

Recruiting now · Not applicable

Conditions studied: Brain Injuries, Traumatic

In brief

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 facts

Study ID: NCT02920788
Run by: VA Office of Research and Development
People needed: 65
Starts: 2017-03-09
Expected to finish: 2027-04-13
Last updated by the study team: 2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 is running

University of California, San Francisco — San Francisco, California, United States (enrolling)
San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.