Resilience and Modification of Brain Control Network Following November 13

Post-Traumatic Stress Disorder Clinical Trial

— REMEMBER  

Official title:

Etude Longitudinale en Imagerie cérébrale, en Neuropsychologie, et en Psychopathologie, Des conséquences d'un événement Traumatique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02810197
• Other study ID #: C16-13
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Pierre Gagnepain, PhD
• Email: gagnepain[@]cyceron.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 30, 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Psychopathological assessment

• Neuropsychological assessment

Device:
• Functional magnetic resonance imaging (fMRI)

Locations

Country	Name	City	State
France	GIP Cyceron	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level Dependent (BOLD) response as measured with fMRI		1 hour