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

NCT01908647 | Unknown

• 1 other identifier: W81XWH-11-2-0180
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Post Traumatic Stress Disorder

Keywords

mTBI; PTSD

Outcome Measures

Primary Outcomes (1)

• Neuropsychological assessments

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

  8 weeks

Secondary Outcomes (4)

• Participant-reported outcomes

  8 weeks

• Working/School Status

  8 weeks

• Exercise Based Assessments

  4 and 8 weeks

• Functional Assessments

  8 weeks

Study Arms (4)

Exp RT fMRI/Exp Cognitive Training

EXPERIMENTAL

Both experimental conditions.

Behavioral: RT fMRI; Behavioral: Cognitive Training

Exp RT fMRI/Ctrl Cognitive training

EXPERIMENTAL

Experimental real-time fMRI and control cognitive training.

Behavioral: RT fMRI; Behavioral: Control Cognitive Training

Ctrl RT fMRI/Exp Cognitive Training

EXPERIMENTAL

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

Behavioral: Cognitive Training; Behavioral: Control RT fMRI

Ctr RT fMRI/Ctr Cognitive Training

SHAM COMPARATOR

Control real-time fMRI and control cognitive training.

Behavioral: Control RT fMRI; Behavioral: Control Cognitive Training

Interventions

RT fMRI BEHAVIORAL

Real-time fMRI with neurofeedback.

Also known as: Real-time fMRI

Exp RT fMRI/Ctrl Cognitive training; Exp RT fMRI/Exp Cognitive Training

Cognitive Training BEHAVIORAL

Computer based attention training.

Ctrl RT fMRI/Exp Cognitive Training; Exp RT fMRI/Exp Cognitive Training

Control RT fMRI BEHAVIORAL

Control condition for real-time fMRI.

Ctr RT fMRI/Ctr Cognitive Training; Ctrl RT fMRI/Exp Cognitive Training

Control Cognitive Training BEHAVIORAL

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

Ctr RT fMRI/Ctr Cognitive Training; Exp RT fMRI/Ctrl Cognitive training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Van Boven, Robert W., M.D.: lead
• The Geneva Foundation: collaborator
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Carl R Darnall Army Medical Center (CRDAMC)

Fort Hood, Texas, 76544, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert Van Boven, M.D.

  The Geneva Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaela Miller

CONTACT

737-346-7017; kmiller@genevausa.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 26, 2013
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

US (1)