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

Van Boven, Robert W., M.D.

Status: Unknown

Conditions: Traumatic Brain Injury; Post Traumatic Stress Disorder

Treatments: Behavioral: Control RT fMRI; Behavioral: Cognitive Training; Behavioral: Control Cognitive Training; Behavioral: RT fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01908647

W81XWH-11-2-0180

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 4 patient groups

Exp RT fMRI/Exp Cognitive Training

Experimental group

Description:

Both experimental conditions.

Treatment:

Behavioral: Cognitive Training

Behavioral: RT fMRI

Exp RT fMRI/Ctrl Cognitive training

Experimental group

Description:

Experimental real-time fMRI and control cognitive training.

Treatment:

Behavioral: Control Cognitive Training

Behavioral: RT fMRI

Ctrl RT fMRI/Exp Cognitive Training

Experimental group

Description:

Control RT fMRI (real-time functional MRI) and experimental cognitive training.

Treatment:

Behavioral: Cognitive Training

Behavioral: Control RT fMRI

Ctr RT fMRI/Ctr Cognitive Training

Sham Comparator group

Description:

Control real-time fMRI and control cognitive training.

Treatment:

Behavioral: Control Cognitive Training

Behavioral: Control RT fMRI