Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI

Status unconfirmed · Not applicable

Conditions studied: Traumatic Brain Injury, Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT01908647

Run by

Van Boven, Robert W., M.D.

People needed

150

Starts

2014-04-01

Last updated by the study team

2014-04-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Carl R Darnall Army Medical Center (CRDAMC) — Fort Hood, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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