REMEMBER: Resilience and Modification of Brain Control Network Following November 13

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT02810197
Collaborator
(none)
180
1
2
82.9
2.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychopathological assessment
  • Behavioral: Neuropsychological assessment
  • Device: Functional magnetic resonance imaging (fMRI)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Etude Longitudinale en Imagerie cérébrale, en Neuropsychologie, et en Psychopathologie, Des conséquences d'un événement Traumatique
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exposed group

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Behavioral: Psychopathological assessment

Behavioral: Neuropsychological assessment

Device: Functional magnetic resonance imaging (fMRI)

Experimental: unexposed group

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Behavioral: Psychopathological assessment

Behavioral: Neuropsychological assessment

Device: Functional magnetic resonance imaging (fMRI)

Outcome Measures

Primary Outcome Measures

  1. Blood Oxygen Level Dependent (BOLD) response as measured with fMRI [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GIP Cyceron Caen Calvados France 14000

Sponsors and Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Vincent de La Sayette, MD, University Hospital, Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT02810197
Other Study ID Numbers:
  • C16-13
First Posted:
Jun 22, 2016
Last Update Posted:
Dec 2, 2021
Last Verified:
Dec 1, 2021

Study Results

No Results Posted as of Dec 2, 2021