PostTraumatic Stress DisorderCOPTSDNCT01405495
PTSD Among Victims of Sexual Abuse and Changes in Structural and Functional Brain Connectivity
An observational study of PostTraumatic Stress Disorder, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PostTraumatic Stress Disorder
- What is being tested?
- MRI-based techniques (sMRI, fMRI, DTI, ASL)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: PTSD related to sexual abuse vs trauma-exposed vs controls, in right-handed females.
Who may be able to join
- Written consent
- affiliated to the National Health Insurance
- without neurological past history
- without psychoactive drugs past history
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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
- Being tested
- MRI-based techniques (sMRI, fMRI, DTI, ASL)
- Keywords
- Posttraumatic Stress Disorder, Working Memory, Attentional Bias, Connectivity, Structural Neuroimaging, Functional Neuroimaging, Diffusion Tensor Imaging, Arterial Spin Labelling, Cortisol, Psychophysiology, Early development of
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-based techniques (sMRI, fMRI, DTI, ASL)Procedure or surgery
Also called structural magnetic resonance imaging, functional magnetic resonance imaging, diffusion tensor imaging, arterial spin labelling
no drugs include
| Study group | Role | What they receive |
|---|---|---|
| PTSD group | Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)' Receives: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL) | |
| Exposed without PTSD | Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)' Receives: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL) | |
| Healthy Controls | Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)' Receives: Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: One month (plus or minus 2 weeks) and 6 months (plus or minus 2 weeks) post trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostTraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wissam El-Hage, MD, PhD, Principal investigator, INSERM U930 Team 4 Affective Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405495
- Sponsor's protocol ID
- PHRI/10/WEH/COPTSD
- Acronym
- COPTSD
- Status last verified
- May 2017
- First submitted
- 7 Jun 2011
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01405495
- Acronym / sponsor ID
- COPTSD / PHRI/10/WEH/COPTSD
- Conditions
- PostTraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Working Memory, Attentional Bias, Connectivity, Structural Neuroimaging, Functional Neuroimaging, Diffusion Tensor Imaging, Arterial Spin Labelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PTSD group | – | Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)' |
| Exposed without PTSD | – | Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)' |
| Healthy Controls | – | Procedure: MRI-based techniques (sMRI, fMRI, DTI, ASL)Intervention 'MRI-based techniques (sMRI, fMRI, DTI, ASL)' |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- PTSD related to sexual abuse vs trauma-exposed vs controls, in right-handed females.
Key inclusion criteria (4 listed)
- Written consent
- affiliated to the National Health Insurance
- without neurological past history
- without psychoactive drugs past history
Key exclusion criteria (8 listed)
- the subject can not follow the instructions
- simultaneous participation to an other study using psychoactive drugs
- blindness
- epilepsy
- addiction to psychoactive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-based techniques (sMRI, fMRI, DTI, ASL)Also: structural magnetic resonance imaging, functional magnetic resonance imaging, diffusion tensor imaging, arterial spin labellingno drugs include | Procedure or surgery | Exposed without PTSD, Healthy Controls, PTSD group |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissam El-Hage, MD, PhD principal investigator
INSERM U930 Team 4 Affective Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PostTraumatic Stress Disorder, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.