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临床试验/NCT01990547
NCT01990547已完成不适用

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

Walter Reed National Military Medical Center1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2013年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Change from baseline functional MRI blood-oxygen-level-dependent (BOLD) signal at 3months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline functional MRI blood-oxygen-level-dependent (BOLD) signal at 3months

时间窗: 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.

次要结局

  • Clinician-Administered PTSD Scale (CAPS)(baseline and 3months)
  • PTSD Checklist-Military Version (PCL-M)(baseline and 3months)
  • CAGE and Alcohol Use Disorders Identification Test (AUDIT)(baseline and 3month)
  • Defense Veteran's Brain Injury Center (DVBIC)screen(baseline and 3months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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