Understanding brain control networks in survivors of the November 13 attacks
Etude Longitudinale En Imagerie Cérébrale, En Neuropsychologie, Et En Psychopathologie, Des Conséquences D'un Événement Traumatique
This study looks at how the brains of people who survived the November 13 attacks in Paris work differently over time compared to those who weren't exposed, to see if this affects their memories and feelings related to PTSD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Caen, Calvados) |
| Trial ID | NCT02810197 on ClinicalTrials.gov |
What this trial studies
This study investigates the resilience and modification of brain control networks in individuals who survived the November 13, 2015, terrorist attacks in Paris. It involves a multiwave longitudinal neuroimaging approach, collecting both structural and functional brain imaging data at various intervals (8-12 months, 3 years, and 6 years) post-trauma. Participants include those directly exposed to the attacks and a control group of non-exposed individuals, allowing for a comparative analysis of brain function and structure related to post-traumatic stress disorder (PTSD). The study aims to explore how memory suppression techniques may differ between these groups and how this affects the experience of intrusive memories associated with PTSD.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 55 who were present at the scene of the attacks or lived in the affected neighborhoods.
Not a fit: Patients with severe psychiatric disorders prior to the attacks or those currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of PTSD and lead to improved therapeutic strategies for managing intrusive memories.
How similar studies have performed: While this approach is novel in the context of the specific traumatic event studied, similar neuroimaging studies have shown promise in understanding PTSD mechanisms.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen, Calvados
- GIP Cyceron — Caen, Calvados, France (Recruiting)
Study contacts
- Principal investigator: Vincent de La Sayette, MD — University Hospital, Caen
- Study coordinator: Pierre Gagnepain, PhD
- Email: gagnepain@cyceron.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.