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临床试验/NCT04406675
NCT04406675已完成不适用

Social Cognition in Patients With Amyotrophic Lateral Sclerosis

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年9月21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
58
试验地点
1
主要终点
Evaluate the social cognition capacities

研究概览

简要总结

Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.

In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Amyotrophic Lateral Sclerosis :
  • Education of at least 7 years
  • Native language: French
  • Patients Amyotrophic Lateral Sclerosis
  • Signature of informed consent to participate in the study
  • Accompanied patient
  • Control subject :
  • People without any pathology
  • Education of at least 7 years
  • Native language: French
  • Signature of informed consent to participate in the study

排除标准

  • Patient Amyotrophic Lateral Sclerosis and control subject :
  • Simultaneous participation in another interventional protocol with experimental treatment
  • Inability to perform cognitive study tests
  • Pregnant, lactating or parturient women
  • Persons deprived of their liberty by administrative or judicial decision
  • Persons under psychiatric care under duress
  • Persons subject to legal protection measures
  • Persons out of state to express their consent
  • People not affiliated or not beneficiaries of a social security scheme
  • History likely to disturb cognition

研究组 & 干预措施

Control subjects

Other

干预措施: neuropsychological test (Other)

Patients Amyotrophic Lateral Sclerosis

Other

干预措施: neuropsychological test (Other)

结局指标

主要结局

Evaluate the social cognition capacities

时间窗: One day

Evaluate the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to control subjects using dynamic social cognition tests : Movie for the Assessment of Social Cognition. The maximum score is 48 points. The higher the score for correct answers, the better the performance.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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