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

April 24, 2014 updated by: Van Boven, Robert W., M.D.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Hood, Texas, United States, 76544
        • Recruiting
        • Carl R Darnall Army Medical Center (CRDAMC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Van Boven, M.D.
        • Sub-Investigator:
          • Greg S Harrington, Ph.D.
        • Sub-Investigator:
          • Satrajit Ghosh, Ph.D.
        • Principal Investigator:
          • John Gabrieli, Ph.D.
        • Principal Investigator:
          • Michel-Alexis Courtines, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological assessments
Time Frame: 8 weeks
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
Time Frame: 8 weeks
A measure of the impact of program use on the participants' own view of their impairment and function
8 weeks
Working/School Status
Time Frame: 8 weeks
A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week
8 weeks
Exercise Based Assessments
Time Frame: 4 and 8 weeks
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
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Van Boven, Robert W., M.D.

Collaborators

Massachusetts Institute of Technology
The Geneva Foundation

Investigators

  • Principal Investigator: Robert Van Boven, M.D., The Geneva Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-11-2-0180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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