Assessment of Neuropsychiatric Involvement in Systemic Sclerosis.
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
- 是
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
Evaluation of Scleroderma patient
干预措施: Magnetic resonance Imaging (Other)
Healthy subjects
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
