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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Goal-Oriented Attentional Self-Regulation (GOALS)
BehavioralGOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.
Brain Health Education (BHE)
Other interventionBHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain.
fMRI
DeviceFunctional Magnetic Resonance Imaging of the Brain
Treatment groups
65 Participants
are divided into 3 treatment groupsGroup A: Veteran Mild TBI Group - GOALS InterventionExperimental treatment 2 interventions
Group B: Veteran Mild TBI - Treatment as UsualActive comparator 2 interventions
Group C: Veteran Non TBI - No TreatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task
Single Test for Attention, Executive Function and Mental Flexibility
Time frame
6 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov