Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: August 29, 2014
Last verified: November 2010
  Purpose

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).


Condition Intervention
PostTraumatic Stress Disorder
Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Salivary cortisol


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PTSD group
Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'
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
Exposed without PTSD
Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'
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
Healthy Controls
Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405495

Contacts
Contact: Wissam El-Hage, MD, PhD +33247478043 el-hage@med.univ-tours.fr

Locations
France
Bretonneau Regional Universitary Hospital Recruiting
Tours, France, 37044 cedex 9
Principal Investigator: Wissam El-Hage, MD, PhD         
Sub-Investigator: Yann Quidé, student         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Wissam El-Hage, MD, PhD INSERM U930 Team 4 Affective Disorders
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01405495     History of Changes
Other Study ID Numbers: PHRI/10/WEH/COPTSD
Study First Received: June 7, 2011
Last Updated: August 29, 2014
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Posttraumatic Stress Disorder
Working Memory
Attentional Bias
Connectivity
Structural Neuroimaging
Functional Neuroimaging
Diffusion Tensor Imaging
Arterial Spin Labelling
Cortisol
Psychophysiology
Early development of

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014