跳至主要内容
临床试验/NCT02110017
NCT02110017Unknown不适用

Exploration of Neural Bases in Social Cognition

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal

研究概览

简要总结

An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.

Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).

Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.

详细描述

Social cognition neural basis. Impairment of the "social brain" in schizophrenia

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged from 18 to 60 years old
  • who have signed a consent and, if there is one, whose legal representant has signed a consent
  • For healthy subjects:
  • without any psychiatric affection (Mini International Neuropsychiatric Interview)
  • For patients
  • meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder

排除标准

  • pregnant woman
  • neurological affection
  • medical objection to Magnetic Resonance Imagery (MRI)

结局指标

主要结局

Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal

时间窗: Day 1 for individual analysis. Up to 24 months for group analysis.

The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p\<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p\<0.05)

次要结局

  • Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.(Day 1 for individual analysis. Up to 24 months for group analysis.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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