Clinical trial NCT02810197: Resilience and Modification of Brain Control Network Following November 13
Official title: Etude Longitudinale En Imagerie Cérébrale, En Neuropsychologie, Et En Psychopathologie, Des Conséquences D'un Événement Traumatique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Blood Oxygen Level Dependent (BOLD) response as measured with fMRI
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: GIP Cyceron
state: Calvados
Study officials:
affiliation: University Hospital, Caen
name: Vincent de La Sayette, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.