Traumatic Brain Injury, Post Traumatic Stress Disorder
Conditions
Keywords
mTBI, PTSD
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.
Interventions
BEHAVIORALRT fMRI
Real-time fMRI with neurofeedback.
BEHAVIORALCognitive Training
Computer based attention training.
BEHAVIORALControl RT fMRI
Control condition for real-time fMRI.
BEHAVIORALControl Cognitive Training
Computer-based games used as a control for the computer based cognitive training intervention.
Sponsors
The Geneva Foundation
Massachusetts Institute of Technology
Van Boven, Robert W., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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. * Subjects should not be enrolled in a concurrent TBI clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological assessments | 8 weeks | A composite score based on four primary domains (learning, memory, working memory and executive function). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactKaela Miller
Outcome results
None listed