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

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

Status: Enrolling

Conditions: Post-Traumatic Stress Disorder

Treatments: Device: Functional magnetic resonance imaging (fMRI); Behavioral: Psychopathological assessment; Behavioral: Neuropsychological assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02810197

C16-13

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Exposed group

Experimental group

Description:

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Treatment:

Behavioral: Neuropsychological assessment

Behavioral: Psychopathological assessment

Device: Functional magnetic resonance imaging (fMRI)

unexposed group

Experimental group

Description:

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

Treatment:

Behavioral: Neuropsychological assessment

Behavioral: Psychopathological assessment

Device: Functional magnetic resonance imaging (fMRI)