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

NCT ID: NCT01405495

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-08-31

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.

Conditions

PostTraumatic Stress Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PTSD group

Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'

MRI-based techniques (sMRI, fMRI, DTI, ASL)

Intervention Type: PROCEDURE

no drugs include

Exposed without PTSD

Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'

MRI-based techniques (sMRI, fMRI, DTI, ASL)

Intervention Type: PROCEDURE

no drugs include

Healthy Controls

Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)'

MRI-based techniques (sMRI, fMRI, DTI, ASL)

Intervention Type: PROCEDURE

no drugs include

Interventions

MRI-based techniques (sMRI, fMRI, DTI, ASL)

no drugs include

Intervention Type: PROCEDURE

Other Intervention Names

structural magnetic resonance imaging; functional magnetic resonance imaging; diffusion tensor imaging; arterial spin labelling

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wissam El-Hage, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INSERM U930 Team 4 Affective Disorders

Locations

Bretonneau Regional Universitary Hospital

Tours, , France

Countries

France

Other Identifiers

PHRI/10/WEH/COPTSD

Identifier Type: -

Identifier Source: org_study_id