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

V

Van Boven, Robert W., M.D.

Status

Unknown

Conditions

Traumatic Brain Injury
Post Traumatic Stress Disorder

Treatments

Behavioral: Control RT fMRI
Behavioral: Cognitive Training
Behavioral: Control Cognitive Training
Behavioral: RT fMRI

Study type

Interventional

Funder types

Other

Identifiers

NCT01908647
W81XWH-11-2-0180

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 4 patient groups

Exp RT fMRI/Exp Cognitive Training
Experimental group
Description:
Both experimental conditions.
Treatment:
Behavioral: Cognitive Training
Behavioral: RT fMRI
Exp RT fMRI/Ctrl Cognitive training
Experimental group
Description:
Experimental real-time fMRI and control cognitive training.
Treatment:
Behavioral: Control Cognitive Training
Behavioral: RT fMRI
Ctrl RT fMRI/Exp Cognitive Training
Experimental group
Description:
Control RT fMRI (real-time functional MRI) and experimental cognitive training.
Treatment:
Behavioral: Cognitive Training
Behavioral: Control RT fMRI
Ctr RT fMRI/Ctr Cognitive Training
Sham Comparator group
Description:
Control real-time fMRI and control cognitive training.
Treatment:
Behavioral: Control Cognitive Training
Behavioral: Control RT fMRI

Trial contacts and locations

1

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Central trial contact

Kaela Miller

Data sourced from clinicaltrials.gov

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