Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
NCT01908647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2014-04-28
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.
Conditions
- Traumatic Brain Injury
- Post Traumatic Stress Disorder
Interventions
- BEHAVIORAL
-
RT fMRI
Real-time fMRI with neurofeedback.
- BEHAVIORAL
-
Cognitive Training
Computer based attention training.
- BEHAVIORAL
-
Control RT fMRI
Control condition for real-time fMRI.
- BEHAVIORAL
-
Control Cognitive Training
Computer-based games used as a control for the computer based cognitive training intervention.
Sponsors & Collaborators
-
The Geneva Foundation
collaborator OTHER -
Massachusetts Institute of Technology
collaborator OTHER -
Van Boven, Robert W., M.D.
lead OTHER
Principal Investigators
-
Robert Van Boven, M.D. · The Geneva Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2015-07-31
Countries
- United States
Study Locations
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