| NCT ID | NCT02920788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Brain Injuries, Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2017-03-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2017-03-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Pratik Mukherjee, MD PhD
PRINCIPAL INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Frequently Asked Questions
Who can join the NCT02920788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Injuries, Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02920788 currently recruiting?
Yes, NCT02920788 is actively recruiting participants. Contact the research team at pratik.mukherjee@ucsf.edu for enrollment information.
Where is the NCT02920788 trial being conducted?
This trial is being conducted at San Francisco, United States, San Francisco, United States.
Who is sponsoring the NCT02920788 clinical trial?
NCT02920788 is sponsored by VA Office of Research and Development. The principal investigator is Pratik Mukherjee, MD PhD at San Francisco VA Medical Center, San Francisco, CA. The trial plans to enroll 65 participants.