Mild TBI Assessment & Rehabilitation
ConditionBrain Injuries, Traumatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Goal-Oriented Attentional Self-Regulation (GOALS)
- Brain Health Education (BHE)
- fMRI
Treatment groups
65 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov