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临床试验/NCT02810197
NCT02810197已完成不适用

Etude Longitudinale en Imagerie cérébrale, en Neuropsychologie, et en Psychopathologie, Des conséquences d'un événement Traumatique

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2016年6月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
1
主要终点
Blood Oxygen Level Dependent (BOLD) response as measured with fMRI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy or intent to get pregnant
  • Person deprived of their liberty
  • Person admitted to a health or social institution for purposes other than research
  • 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

研究组 & 干预措施

unexposed group

Experimental

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

干预措施: Neuropsychological assessment (Behavioral)

unexposed group

Experimental

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

干预措施: Functional magnetic resonance imaging (fMRI) (Device)

Exposed group

Experimental

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

干预措施: Neuropsychological assessment (Behavioral)

unexposed group

Experimental

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

干预措施: Psychopathological assessment (Behavioral)

Exposed group

Experimental

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

干预措施: Functional magnetic resonance imaging (fMRI) (Device)

Exposed group

Experimental

Psychopathological assessment Neuropsychological assessment Functional magnetic resonance imaging (fMRI)

干预措施: Psychopathological assessment (Behavioral)

结局指标

主要结局

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

时间窗: 1 hour

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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