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

NCT01405495 | Completed DMC

• 1 other identifier: PHRI/10/WEH/COPTSD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

PostTraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Working Memory; Attentional Bias; Connectivity; Structural Neuroimaging; Functional Neuroimaging; Diffusion Tensor Imaging; Arterial Spin Labelling; Cortisol; Psychophysiology; Early development of

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (3)

PTSD group

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

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

Exposed without PTSD

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

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

Healthy Controls

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

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

Interventions

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

no drugs include

Also known as: structural magnetic resonance imaging, functional magnetic resonance imaging, diffusion tensor imaging, arterial spin labelling

Exposed without PTSD; Healthy Controls; PTSD group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Bretonneau Regional Universitary Hospital

Tours, 37044 cedex 9, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary cortisol

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Wissam El-Hage, MD, PhD

  INSERM U930 Team 4 Affective Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: July 29, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

FR (1)