Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
- Conditions
- Traumatic Brain InjuryPost Traumatic Stress Disorder
- Interventions
- Behavioral: RT fMRIBehavioral: Cognitive TrainingBehavioral: Control Cognitive TrainingBehavioral: Control RT fMRI
- Registration Number
- NCT01908647
- Lead Sponsor
- Van Boven, Robert W., M.D.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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.
- Subjects should not be enrolled in a concurrent TBI clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exp RT fMRI/Exp Cognitive Training RT fMRI Both experimental conditions. Exp RT fMRI/Exp Cognitive Training Cognitive Training Both experimental conditions. Exp RT fMRI/Ctrl Cognitive training RT fMRI Experimental real-time fMRI and control cognitive training. Exp RT fMRI/Ctrl Cognitive training Control Cognitive Training Experimental real-time fMRI and control cognitive training. Ctrl RT fMRI/Exp Cognitive Training Cognitive Training Control RT fMRI (real-time functional MRI) and experimental cognitive training. Ctrl RT fMRI/Exp Cognitive Training Control RT fMRI Control RT fMRI (real-time functional MRI) and experimental cognitive training. Ctr RT fMRI/Ctr Cognitive Training Control RT fMRI Control real-time fMRI and control cognitive training. Ctr RT fMRI/Ctr Cognitive Training Control Cognitive Training Control real-time fMRI and control cognitive training.
- Primary Outcome Measures
Name Time Method Neuropsychological assessments 8 weeks A composite score based on four primary domains (learning, memory, working memory and executive function).
- Secondary Outcome Measures
Name Time Method Participant-reported outcomes 8 weeks A measure of the impact of program use on the participants' own view of their impairment and function
Working/School Status 8 weeks A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week
Exercise Based Assessments 4 and 8 weeks Three sets of assessments that are closely modeled on study-related exercises in the auditory, visual, and cognitive control modules, and include auditory speed of processing, visual speed of processing, and cognitive control speed of processing.
Functional Assessments 8 weeks Two types of functional measures: a sensitive directly observed performance measure designed originally for normal cognitive aging (timed instrumental activities of daily living, TIADL), and a well-accepted clinical impression measure (the Mayo-Portland Adaptability Inventory, MPAI-4).
Trial Locations
- Locations (1)
Carl R Darnall Army Medical Center (CRDAMC)
🇺🇸Fort Hood, Texas, United States