Clinical trial NCT01908647: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Post Traumatic Stress Disorder
Keywords: mTBI
PTSD
Lead sponsor: Van Boven, Robert W., M.D.
Sponsor class: OTHER
Collaborators: name: The Geneva Foundation
name: Massachusetts Institute of Technology
First posted: 2013-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Neuropsychological assessments
timeFrame: 8 weeks
Secondary outcomes:
measure: Participant-reported outcomes
timeFrame: 8 weeks
measure: Working/School Status
timeFrame: 8 weeks
measure: Exercise Based Assessments
timeFrame: 4 and 8 weeks
measure: Functional Assessments
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R Darnall Army Medical Center (CRDAMC)
state: Texas
Study officials:
affiliation: The Geneva Foundation
name: Robert Van Boven, M.D.
role: PRINCIPAL_INVESTIGATOR
References: