NCT02810197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

June 20, 2016

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    1 hour

Study Arms (2)

Exposed group

EXPERIMENTAL

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Behavioral: Psychopathological assessmentBehavioral: Neuropsychological assessmentDevice: Functional magnetic resonance imaging (fMRI)

unexposed group

EXPERIMENTAL

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Behavioral: Psychopathological assessmentBehavioral: Neuropsychological assessmentDevice: Functional magnetic resonance imaging (fMRI)

Interventions

Exposed groupunexposed group
Exposed groupunexposed group
Exposed groupunexposed group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GIP Cyceron

Caen, Calvados, 14000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Neuropsychological TestsMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Vincent de La Sayette, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

June 13, 2016

Primary Completion

June 12, 2017

Study Completion

December 16, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations