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

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).

Study Overview

• Status: Completed
• Conditions: PostTraumatic Stress Disorder
• Intervention / Treatment: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044 cedex 9
    • Bretonneau Regional Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTSD group; Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'	Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL); no drugs include; Other Names: functional magnetic resonance imaging; structural 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: functional magnetic resonance imaging; structural 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: functional magnetic resonance imaging; structural magnetic resonance imaging; diffusion tensor imaging; arterial spin labelling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline brain connectivity in sexual assault female victims who developed PTSD compared to victims without PTSD and healthy control at 6 months.	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.	One month (plus or minus 2 weeks) and 6 months (plus or minus 2 weeks) post trauma

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Wissam El-Hage, MD, PhD, INSERM U930 Team 4 Affective Disorders

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Cortisol; Functional Neuroimaging; Diffusion Tensor Imaging; Posttraumatic Stress Disorder; Working Memory; Connectivity; Psychophysiology; Attentional Bias; Structural Neuroimaging; Arterial Spin Labelling; Early development of
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: PHRI/10/WEH/COPTSD