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Clinical Trials/NCT01405495
NCT01405495
Completed
N/A

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 site in 1 country60 target enrollmentFebruary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
PostTraumatic Stress Disorder
Sponsor
University Hospital, Tours
Enrollment
60
Locations
1
Primary Endpoint
Changes from baseline brain connectivity in sexual assault female victims who developed PTSD compared to victims without PTSD and healthy control at 6 months.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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