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Search / Trial NCT02920788

Mild TBI Assessment & Rehabilitation

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Sep 28, 2016

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Rehabilitation Functional Magnetic Resonance Imaging

ClinConnect Summary

This clinical trial, called "Mild TBI Assessment & Rehabilitation," is focused on helping Veterans who have experienced mild traumatic brain injuries (mTBI) and may also face emotional challenges. The study aims to find out if training that helps improve attention and self-control through activities that matter personally to the Veterans can make their daily lives better. Researchers will look at whether this training leads to real improvements in thinking and behavior, as well as how it affects the brain areas involved in these functions.

To participate in this study, Veterans must be at least 18 years old and have a history of mild TBI, confirmed by medical records. Participants will need to show they have some ongoing cognitive difficulties that affect their daily life. The study welcomes all genders and does not limit participation based on race or income. Participants can expect to engage in training sessions and assessments, and they will be closely monitored throughout the study. Importantly, this research could help pave the way for future studies aimed at understanding how to best support Veterans with brain injuries and enhance their quality of life.

Gender

ALL

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 neuropscyhiatric disorders, including depression and PTSD.
  • There will be no restriction in regard to gender, race and socioeconomic status

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

San Francisco, California, United States

San Francisco, California, United States

San Francisco, California, United States

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Pratik Mukherjee, MD PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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