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

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumatic Brain Injury, Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: RT fMRI
* Behavioral: Cognitive Training
* Behavioral: Control RT fMRI
* Behavioral: Control Cognitive Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exp RT fMRI/Exp Cognitive Training<br>Both experimental conditions. | Behavioral: RT fMRI<br>* Real-time fMRI with neurofeedback.<br>* Other names: Real-time fMRI;Behavioral: Cognitive Training<br>* Computer based attention training.<br>|
| Experimental: Exp RT fMRI/Ctrl Cognitive training<br>Experimental real-time fMRI and control cognitive training. | Behavioral: RT fMRI<br>* Real-time fMRI with neurofeedback.<br>* Other names: Real-time fMRI;Behavioral: Control Cognitive Training<br>* Computer-based games used as a control for the computer based cognitive training intervention.<br>|
| Experimental: Ctrl RT fMRI/Exp Cognitive Training<br>Control RT fMRI (real-time functional MRI) and experimental cognitive training. | Behavioral: Cognitive Training<br>* Computer based attention training.<br>Behavioral: Control RT fMRI<br>* Control condition for real-time fMRI.<br>|
| Sham Comparator: Ctr RT fMRI/Ctr Cognitive Training<br>Control real-time fMRI and control cognitive training. | Behavioral: Control RT fMRI<br>* Control condition for real-time fMRI.<br>Behavioral: Control Cognitive Training<br>* Computer-based games used as a control for the computer based cognitive training intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological assessments | A composite score based on four primary domains (learning, memory, working memory and executive function). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant-reported outcomes | A measure of the impact of program use on the participants' own view of their impairment and function | 8 weeks | 
| Working/School Status | A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week | 8 weeks | 
| Exercise Based Assessments | Three sets of assessments that are closely modeled on study-related exercises in the auditory, visual, and cognitive control modules, and include auditory speed of processing, visual speed of processing, and cognitive control speed of processing. | 4 and 8 weeks | 
| Functional Assessments | Two types of functional measures: a sensitive directly observed performance measure designed originally for normal cognitive aging (timed instrumental activities of daily living, TIADL), and a well-accepted clinical impression measure (the Mayo-Portland Adaptability Inventory, MPAI-4). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mTBI, PTSD