Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | April 2014 |
| Contact: | Kaela Miller |
| Email: | kmiller@genevausa.org |
| Phone: | 737-346-7017 |
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
