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Resilience and Modification of Brain Control Network Following November 13 (REMEMBER)

Primary Purpose

Post-Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychopathological assessment
Neuropsychological assessment
Functional magnetic resonance imaging (fMRI)
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GIP CyceronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exposed group

unexposed group

Arm Description

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Outcomes

Primary Outcome Measures

Blood Oxygen Level Dependent (BOLD) response as measured with fMRI

Secondary Outcome Measures

Full Information

First Posted
June 20, 2016
Last Updated
December 1, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02810197
Brief Title
Resilience and Modification of Brain Control Network Following November 13
Acronym
REMEMBER
Official Title
Etude Longitudinale en Imagerie cérébrale, en Neuropsychologie, et en Psychopathologie, Des conséquences d'un événement Traumatique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposed group
Arm Type
Experimental
Arm Description
Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)
Arm Title
unexposed group
Arm Type
Experimental
Arm Description
Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)
Intervention Type
Behavioral
Intervention Name(s)
Psychopathological assessment
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological assessment
Intervention Type
Device
Intervention Name(s)
Functional magnetic resonance imaging (fMRI)
Primary Outcome Measure Information:
Title
Blood Oxygen Level Dependent (BOLD) response as measured with fMRI
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Gagnepain, PhD
Email
gagnepain@cyceron.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent de La Sayette, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
GIP Cyceron
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35479300
Citation
Coll SY, Eustache F, Doidy F, Fraisse F, Peschanski D, Dayan J, Gagnepain P, Laisney M. Avoidance behaviour generalizes to eye processing in posttraumatic stress disorder. Eur J Psychotraumatol. 2022 Apr 20;13(1):2044661. doi: 10.1080/20008198.2022.2044661. eCollection 2022.
Results Reference
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Resilience and Modification of Brain Control Network Following November 13

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