Recruiting

Neurofeedback & CRBI

Sponsor:

Van Boven, Robert W., M.D.

Code:

NCT01908647

Conditions

Traumatic Brain Injury

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

RT fMRI

Cognitive Training

Control RT fMRI

Control Cognitive Training

Study Details

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

Study ID

NCT01908647

Start date

Apr, 2014

Status verified date

Apr, 2014

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exp RT fMRI/Exp Cognitive Training

Both experimental conditions.

experimental: Exp RT fMRI/Ctrl Cognitive training

Experimental real-time fMRI and control cognitive training.

experimental: Ctrl RT fMRI/Exp Cognitive Training

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

sham comparator: Ctr RT fMRI/Ctr Cognitive Training

Control real-time fMRI and control cognitive training.

Interventions

RT fMRI

Real-time fMRI with neurofeedback.

Cognitive Training

Computer based attention training.

Control RT fMRI

Control condition for real-time fMRI.

Control Cognitive Training

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

Primary outcome measure

  • Neuropsychological assessments [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Kaela Miller

737-346-7017kmiller@genevausa.org

Locations

Carl R Darnall Army Medical Center (CRDAMC)

Recruiting

Fort Hood, Texas, United States, 76544

Contacts

Robert Van Boven, M.D.

847-477-9317robert.vanboven@gmail.com

Michel-Alexis Courines, M.D.

254-288-8309michel.a.courtines.mil@mail.mil

Principal Investigator:

Robert Van Boven, M.D.

More Information

Sponsor

Van Boven, Robert W., M.D.

Last update posted

Apr 28, 2014

Last verified

Apr, 2014

Keywords

  • mTBI
  • PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Van Boven, Robert W., M.D. on 2014-04-28.