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Trial record 1 of 62 for:    REMEMBER | France
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Resilience and Modification of Brain Control Network Following November 13 (REMEMBER)

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ClinicalTrials.gov Identifier: NCT02810197
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):

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
Post-Traumatic Stress Disorder Behavioral: Psychopathological assessment Behavioral: Neuropsychological assessment Device: Functional magnetic resonance imaging (fMRI)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2016
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 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 [ Time Frame: 1 hour ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810197


Contacts
Contact: Pierre Gagnepain, PhD gagnepain@cyceron.fr

Locations
France
GIP Cyceron Recruiting
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
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02810197     History of Changes
Other Study ID Numbers: C16-13
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders