PTSD Among Victims of Sexual Abuse and Changes in Structural and Functional Brain Connectivity (COPTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01405495
First received: June 7, 2011
Last updated: March 28, 2013
Last verified: November 2010

June 7, 2011
March 28, 2013
February 2012
August 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
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 ] [ Designated as safety issue: Yes ]
We will measure differences in cerebral functional (fMRI) and morphologhic (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.
Complete list of historical versions of study NCT01405495 on ClinicalTrials.gov Archive Site
Changes from baseline cerebral activity between groups during cognitive tasks and difference between groups in measures of specific brain structure volumes at 6 months. [ Time Frame: One month (plus or minus 2 weeks) and 6 months (plus or minus 2 weeks) post trauma ] [ Designated as safety issue: Yes ]
We will measure differences in cerebral activity during cognitive tasks in the different groups of participants. It will allow us to understand what are the specific differences induced by the disorder, but also by the exposition to a traumatic event, compared to healthy controls. Also, according to the literature, we will measure the differences in specific brain structure volumes (e.g., hippocampus)between the different groups.
Same as current
Not Provided
Not Provided
 
PTSD Among Victims of Sexual Abuse and Changes in Structural and Functional Brain Connectivity
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)

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Salivary cortisol

Probability Sample

PTSD related to sexual abuse vs trauma-exposed vs controls, in right-handed females.

PostTraumatic Stress Disorder
Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)
no drugs include
Other Names:
  • structural magnetic resonance imaging
  • functional magnetic resonance imaging
  • diffusion tensor imaging
  • arterial spin labelling
  • PTSD group
    Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'
    Intervention: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)
  • Exposed without PTSD
    Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'
    Intervention: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)
  • Healthy Controls
    Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'
    Intervention: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2015
August 2014   (final data collection date for primary outcome measure)

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
  • epilepsy
  • 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
Female
18 Years to 50 Years
Yes
Contact: Wissam El-Hage, MD, PhD +33247478043 el-hage@med.univ-tours.fr
France
 
NCT01405495
PHRI/10/WEH/COPTSD
Yes
University Hospital, Tours
University Hospital, Tours
Not Provided
Principal Investigator: Wissam El-Hage, MD, PhD INSERM U930 Team 4 Affective Disorders
University Hospital, Tours
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP