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临床试验/NCT02550275
NCT02550275已完成不适用

Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM

研究概览

简要总结

Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all particpipants
  • Patient gave its written consent
  • between 20 and 70 years
  • School level : at least 7 years
  • native language: french
  • For presymptomatic patient
  • Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
  • Unified Huntington Disease Rating Scale moteur ≤ 5
  • For symptomatic patient
  • Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
  • Unified Huntington Disease Rating Scale moteur > 5

排除标准

  • No national health insurance affiliation
  • Being under guardianship
  • Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI
  • Pregnant or lactating women
  • Patient with involuntary movement hampering the realization of MRI

结局指标

主要结局

the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM

时间窗: 3 months after inclusion

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 (2)

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