Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder

Completed

• Conditions: Blast Injury; Post-Traumatic Stress Disorder

• Registration Number: NCT01990547
• Lead Sponsor: Walter Reed National Military Medical Center

Brief Summary

The main purpose of this study is to determine whether functional magnetic resonance imaging (fMRI), can distinguish between service members with and without traumatic brain injury (TBI), as well as those with posttraumatic stress disorder (PTSD) who receive either virtual reality exposure therapy (VRET) or PTSD treatment other than exposure therapy. The investigators and other investigators have previously identified changes in function in multiple regions of the brain in combat veterans with PTSD, and the investigators have also seen that structural changes in the white matter associated with combat TBI are also linked with changes in function, and in turn with PTSD symptoms. However, the investigators need to confirm these findings in larger numbers, and also need to discern whether fMRI can distinguish if there is something significantly different about those who have PTSD after TBI vs. those in whom it does not follow a TBI. Finally, the investigators have previously demonstrated that exposure therapy ameliorates the functional changes in the brain induced by PTSD, but the investigators do not know if similar changes occur with other forms of therapy, so the investigators seek to compare the two directly. It is our expectation that the findings will better inform the choice of therapy for service members with combat-related PTSD, with or without TBI.

Detailed Description

The investigators have previously demonstrated that military service members (SMs) with PTSD related to deployment to Iraq or Afghanistan have fMRI brain activation patterns similar to those reported in other populations with PTSD. The investigators have also demonstrated significant improvements, or normalization, in the activation of each of these brain areas following exposure therapy. In this study the investigators will assess recovery in SMs receiving virtual reality exposure therapy, comparing them to healthy veterans, those with history of blast exposure and those with PTSD receiving usual care. The investigators hope to (1) demonstrate that fMRI can distinguish between military service members with PTSD, with mild TBI, and those who have neither; (2) demonstrate that significant differences are not seen in brain activation patterns merely by repeating fMRI scans at 3 month intervals but when significant changes are present they in fact represent the effect of the exposure therapy intervention; (3) discern whether those with PTSD after TBI have different activation patterns than those with PTSD in the absence of TBI; and (4) identify fMRI characteristics of resilience in service members who have been deployed but did not develop PTSD.

Study Timeline

• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline functional MRI blood-oxygen-level-dependent (BOLD) signal at 3months	baseline and 3months	Functional MRI: Requires the exposure of subjects to various sensory stimuli while in the scanner, in order to assess the function of specific regions of the brain, by measuring the blood-oxygen-level-dependent (BOLD) signal. The Affective Stroop is a validated series of stimuli for distinguishing between those with PTSD and controls, that entails showing participants a variety of pictures (some neutral and some emotionally charged), and also asks them to distinguish between various number patterns.

Secondary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale (CAPS)	baseline and 3months	CAPS: Gold standard, 17-page instrument for the diagnosis of PTSD, which also provides a scaled measure of severity which can be followed for response to therapy.
PTSD Checklist-Military Version (PCL-M)	baseline and 3months	PCL-M: This is a version of the 17-item PTSD Checklist that is oriented towards military veterans. Its psychometric properties have been well-established, and this version generally seems to perform better than the corresponding civilian version.
CAGE and Alcohol Use Disorders Identification Test (AUDIT)	baseline and 3month	CAGE \& AUDIT: assess for alcohol abuse and dependence.
Defense Veteran's Brain Injury Center (DVBIC)screen	baseline and 3months	Defense Veteran's Brain Injury Center (DVBIC) screen: A yes or no questionnaire regarding head injury with loss of consciousness and the presence of subsequent symptoms).

Trial Locations

Locations (1)

National Intrepid Center of Excellence / Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States