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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01908647
• Other study ID #: W81XWH-11-2-0180
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2013
• Last updated: April 24, 2014
• Start date: April 2014

Study information

• Verified date: April 2014
• Source: Van Boven, Robert W., M.D.
• Contact: Kaela Miller
• Phone: 737-346-7017
• Email: kmiller[@]genevausa.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Carl R Darnall Army Medical Center (CRDAMC)	Fort Hood	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Van Boven, Robert W., M.D.	Massachusetts Institute of Technology, The Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological assessments	A composite score based on four primary domains (learning, memory, working memory and executive function).	8 weeks	No
Secondary	Participant-reported outcomes	A measure of the impact of program use on the participants' own view of their impairment and function	8 weeks	No
Secondary	Working/School Status	A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week	8 weeks	No
Secondary	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.	4 and 8 weeks	No
Secondary	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).	8 weeks	No