- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02810197
Resilience and Modification of Brain Control Network Following November 13 (REMEMBER)
February 13, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Etude Longitudinale en Imagerie cérébrale, en Neuropsychologie, et en Psychopathologie, Des conséquences d'un événement Traumatique
This is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13 Paris terrorist attacks.
Both structural and functional brain imaging data will be collected at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in control non-exposed participants.
This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance.
This process is believed to be affected in Post-traumatic stress disorder (PTSD) which is characterized by anxiety and persistent intrusive memory of the traumatic event with highly distressing contents.
This project will thus provide a unique opportunity to observe the online and structural dysfunctions of intrusion control network following a severe psychological trauma and how such process may contribute to recovery and psychopathological dynamics.
In addition, the disruption of social cognition and emotional processing following PTSD will also be investigated in relation to disrupted inhibitory control functioning.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Calvados
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Caen, Calvados, France, 14000
- GIP Cyceron
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants between 18 and 55 years old.
- Present at the scene of the attacks the evening of 13 November 2015 or inhabitant of one of the neighbourhood affected by the attacks (exposed group), or persons were not in Paris on the evening of the attacks and not residing in Paris and its region (unexposed group).
- Affiliated to the French national health care system
- Have a good knowledge of the French language
- Right-handed
- Body mass less than or equal to 35kg/m2
- Signed written consent form
Exclusion Criteria:
- Pregnancy or intent to get pregnant
- Person deprived of their liberty
- Person admitted to a health or social institution for purposes other than research
- Minor
- Person subjected to an exclusion period related to another protocol
- History of severe psychiatric disorders before the attacks : psychotic disorders, bipolar disorder, obsessive compulsive disorder and / or substance use disorders (excluding tobacco addiction)
- Use of medication that may interfere with cognitive or cerebral functioning
- Presence of visual or hearing troubles that may compromise participant's ability to participate in the study
- MRI Contraindications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exposed group
Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)
|
|
|
Experimental: unexposed group
Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood Oxygen Level Dependent (BOLD) response as measured with fMRI
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vincent de La Sayette, MD, University Hospital, Caen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2016
Primary Completion (Actual)
June 12, 2017
Study Completion (Actual)
December 16, 2025
Study Registration Dates
First Submitted
June 20, 2016
First Submitted That Met QC Criteria
June 20, 2016
First Posted (Estimated)
June 22, 2016
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Mental Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Diagnostic Techniques and Procedures
- Diagnosis
- Behavioral Disciplines and Activities
- Tomography
- Diagnostic Imaging
- Psychological Tests
- Magnetic Resonance Imaging
- Neuropsychological Tests
Other Study ID Numbers
- C16-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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