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临床试验/NCT01488214
NCT01488214已完成不适用

Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.

University Hospital, Lille8 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2011年2月16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
108
试验地点
8
主要终点
Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities

研究概览

简要总结

Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter hyperintensities have been reported suggested CNS vascular manifestations in systemic sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric manifestations in systemic sclerosis is unknown. The primary objective of this prospective and multicentre study is to assess a link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis. Secondary objectives are to assess the frequency of neuropsychiatric manifestations, to compare central nervous system abnormality between scleroderma patient and healthy subjects. Central nervous system involvement and neuropsychiatric manifestations will be systematically assessed through central nervous system imaging and questionnaires.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female between 18 and 65 yo
  • With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
  • Informed consent given

排除标准

  • Other auto-immune disease
  • non french native speakers
  • severe arterial hypertension
  • renal insufficiency
  • cranial trauma
  • history of neurological disorder or neurotoxic treatment
  • pregnancy or breast feeding
  • impossibility or non compliance to perform the protocol flow chart
  • contra indications to MRI

研究组 & 干预措施

Scleroderma patient

Experimental

Evaluation of Scleroderma patient

干预措施: Magnetic resonance Imaging (Other)

Healthy subjects

Placebo Comparator

Evaluation of healthy subjects

干预措施: Magnetic resonance Imaging (Other)

结局指标

主要结局

Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities

时间窗: 5 weeks

Odds-ratio between neuropsychiatric manifestations and magnetic resonance imaging abnormalities

次要结局

未报告次要终点

研究者

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

研究点 (8)

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