Status:
UNKNOWN
Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
Lead Sponsor:
Van Boven, Robert W., M.D.
Collaborating Sponsors:
The Geneva Foundation
Massachusetts Institute of Technology
Conditions:
Traumatic Brain Injury
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-45 years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01908647
Start Date
April 1 2014
Last Update
April 28 2014
Active Locations (1)
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1
Carl R Darnall Army Medical Center (CRDAMC)
Fort Hood, Texas, United States, 76544