Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Van Boven, Robert W., M.D.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Neuropsychological assessments
- Last Updated
- 12 years ago
Overview
Brief Summary
In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mild TBI: PTA/confusion≤1 hour immediately after injury; or LOC \<30 min \[69\] confirmed by the Ohio confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
- •Age 18-45 years
- •Right handed \[70\].
- •Minimum of 4 months and within 36 months post-injury
- •Can participate in fMRI and outcome assessment
- •Adequate visual, auditory, sensory-motor function for training program.
- •Fluent in English
- •Persistent cognitive dysfunction confirmed by an objective measure
Exclusion Criteria
- •History of hypoxic event
- •Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
- •Current illicit drug use or ETOH abuse
- •Contraindications to MRI (metal, pregnant, pacemaker, claustrophobia, etc.).
- •Unwilling or unable (e.g. language barrier) to participate
- •Hospitalization during study
- •Current Med Board for discharge, Litigation/ + malingering test \[71\]
- •Use of medications to enhance cognitive function (e.g. Ritalin)
- •Initial Glascow Coma Score \<13 or penetrating head injury
- •Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS; 111). Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
Outcomes
Primary Outcomes
Neuropsychological assessments
Time Frame: 8 weeks
A composite score based on four primary domains (learning, memory, working memory and executive function).
Secondary Outcomes
- Participant-reported outcomes(8 weeks)
- Working/School Status(8 weeks)
- Exercise Based Assessments(4 and 8 weeks)
- Functional Assessments(8 weeks)