Clinical Trials Directory

Trials / Completed

CompletedNCT01990547

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

The ViRTICo-BP Trials: Virtual Reality Therapy and Imaging in Combat Veterans With Blast Injury and Posttraumatic Stress Disorder

Status
Completed
Phase
Study type
Observational
Enrollment
88 (estimated)
Sponsor
Walter Reed National Military Medical Center · Federal
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Primary completion
2014-07-01
Completion
2014-08-01
First posted
2013-11-21
Last updated
2016-02-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01990547. Inclusion in this directory is not an endorsement.