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临床试验/NCT01405495
NCT01405495已完成不适用

Posttraumatic Stress Disorder (PTSD) Among Victims of Sexual Abuse and Changes in Structural and Functional Brain Connectivity: A Cognitive and Neuroanatomical Markers Study Using fMRI,(DTI) and(ASL)

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Changes from baseline brain connectivity in sexual assault female victims who developed PTSD compared to victims without PTSD and healthy control at 6 months.

研究概览

简要总结

The goal of this study is to identify the early modifications in fronto-temporal connectivity in female victims who developed PTSD, compared to female victims who did not develop the disorder, and to healthy control females. The investigators will compare between all these groups, structural and functional differences using different techniques (MRI, fMRI, DTI and ASL), and paradigms (cognitive tasks or at rest).

详细描述

Most of the transversal neuroimaging studies in posttraumatic stress disorder (PTSD) were conducted in male war veterans. Few studies focused on neuroanatomical correlates of PTSD in civilian populations, and only one prospective study explored the cerebral connectivity when developing the disorder. In France, physical and sexual assaults are the most prevalent causes of PTSD, especially in the female population. Neuroanatomic basis of chronic PTSD are now well-defined, implicating limbic over-activation (amygdala), associated with a default activation in prefrontal cortex. However, mechanisms implied in the modification of fronto-limbic regions connectivity, especially in the anterior cingulate cortex (ACC), need further investigations. Will the post-traumatic amygdalar over-activation perturbate the normal functioning of the ACC, or is there a modification in the ACC functioning which leads to a default in amygdala inhibition ? This question is of interest, since the prefrontal cortex, including the ACC, has an essential role in different kind of cognitive activities in the normal and pathological brain, such as working memory and attentional processes.

The goal of this study is to characterize early modifications in structural and functional connectivity in brain structures implied in the development of PTSD using different kinds of MRI-based techniques (structural MRI, fMRI, DTI and ASL), as well as biological (cortisol) and psychophysiological (skin conductance ...) measures in female patients developing PTSD, compared to women exposed to trauma who did not develop the disorder and to healthy controls.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Written consent
  • affiliated to the National Health Insurance
  • without neurological past history
  • without psychoactive drugs past history

排除标准

  • the subject can not follow the instructions
  • simultaneous participation to an other study using psychoactive drugs
  • blindness
  • addiction to psychoactive drugs
  • MRI counter-indications (pace-makers ...)
  • claustrophobia
  • every circumstances making the subject unable to understand the nature, the objectives or the consequences of the study

结局指标

主要结局

Changes from baseline brain connectivity in sexual assault female victims who developed PTSD compared to victims without PTSD and healthy control at 6 months.

时间窗: One month (plus or minus 2 weeks) and 6 months (plus or minus 2 weeks) post trauma

We will measure differences in cerebral functional (fMRI) and morphologic (DTI) connectivity during cognitive tasks or at rest in the different groups of participants. It will allow us to understand what are the specific connectivity differences induced by the disorder, but also by the exposition to a traumatic event, compared to healthy controls.

次要结局

  • Changes from baseline cerebral activity between groups during cognitive tasks and difference between groups in measures of specific brain structure volumes at 6 months.(One month (plus or minus 2 weeks) and 6 months (plus or minus 2 weeks) post trauma)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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