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

Primary Purpose

Traumatic Brain Injury, Post Traumatic Stress Disorder

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RT fMRI

Cognitive Training

Control RT fMRI

Control Cognitive Training

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring mTBI, PTSD

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Carl R Darnall Army Medical Center (CRDAMC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

Exp RT fMRI/Exp Cognitive Training

Exp RT fMRI/Ctrl Cognitive training

Ctrl RT fMRI/Exp Cognitive Training

Ctr RT fMRI/Ctr Cognitive Training

Arm Description

Both experimental conditions.

Experimental real-time fMRI and control cognitive training.

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

Control real-time fMRI and control cognitive training.

Outcomes

Primary Outcome Measures

Neuropsychological assessments

A composite score based on four primary domains (learning, memory, working memory and executive function).

Secondary Outcome Measures

Participant-reported outcomes

A measure of the impact of program use on the participants' own view of their impairment and function

Working/School Status

A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week

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.

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).

Full Information

NCT ID

NCT01908647

First Posted

July 22, 2013

Last Updated

April 24, 2014

Sponsor

Van Boven, Robert W., M.D.

Collaborators

The Geneva Foundation, Massachusetts Institute of Technology

1. Study Identification

Unique Protocol Identification Number

NCT01908647

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Van Boven, Robert W., M.D.

Collaborators

The Geneva Foundation, Massachusetts Institute of Technology

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Post Traumatic Stress Disorder

Keywords

mTBI, PTSD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exp RT fMRI/Exp Cognitive Training

Arm Type

Experimental

Arm Description

Both experimental conditions.

Arm Title

Exp RT fMRI/Ctrl Cognitive training

Arm Type

Experimental

Arm Description

Experimental real-time fMRI and control cognitive training.

Arm Title

Ctrl RT fMRI/Exp Cognitive Training

Arm Type

Experimental

Arm Description

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

Arm Title

Ctr RT fMRI/Ctr Cognitive Training

Arm Type

Sham Comparator

Arm Description

Control real-time fMRI and control cognitive training.

Intervention Type

Behavioral

Intervention Name(s)

RT fMRI

Other Intervention Name(s)

Real-time fMRI

Intervention Description

Real-time fMRI with neurofeedback.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Training

Intervention Description

Computer based attention training.

Intervention Type

Behavioral

Intervention Name(s)

Control RT fMRI

Intervention Description

Control condition for real-time fMRI.

Intervention Type

Behavioral

Intervention Name(s)

Control Cognitive Training

Intervention Description

Computer-based games used as a control for the computer based cognitive training intervention.

Primary Outcome Measure Information:

Title

Neuropsychological assessments

Description

A composite score based on four primary domains (learning, memory, working memory and executive function).

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Participant-reported outcomes

Description

A measure of the impact of program use on the participants' own view of their impairment and function

Time Frame

8 weeks

Title

Working/School Status

Description

A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week

Time Frame

8 weeks

Title

Exercise Based Assessments

Description

Time Frame

4 and 8 weeks

Title

Functional Assessments

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kaela Miller

Phone

737-346-7017

kmiller@genevausa.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Van Boven, M.D.

Organizational Affiliation

The Geneva Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carl R Darnall Army Medical Center (CRDAMC)

City

Fort Hood

State/Province

Texas

ZIP/Postal Code

76544

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Van Boven, M.D.

Phone

847-477-9317

robert.vanboven@gmail.com

First Name & Middle Initial & Last Name & Degree

Michel-Alexis Courines, M.D.

Phone

254-288-8309

michel.a.courtines.mil@mail.mil

First Name & Middle Initial & Last Name & Degree

Robert Van Boven, M.D.

First Name & Middle Initial & Last Name & Degree

Greg S Harrington, Ph.D.

First Name & Middle Initial & Last Name & Degree

Satrajit Ghosh, Ph.D.

First Name & Middle Initial & Last Name & Degree

John Gabrieli, Ph.D.

First Name & Middle Initial & Last Name & Degree

Michel-Alexis Courtines, M.D.

12. IPD Sharing Statement

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

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