NCT03541226已完成不适用
Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2014年9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
- 134
- 试验地点
- 1
- 主要终点
- severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0
研究概览
简要总结
The purpose of this study is to develop tools to detect, measure, monitor and predict axonal damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to consider as early as possible an adaptation of the background treatment in patients with MS. patients with radiological criteria of poor long-term clinical course.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who has had a CIS of less than 4 months (+/- 15 days), with at least 1 inflammatory lesion on his initial brain MRI or with normal brain MRI associated with the presence of oligoclonal bands in the CSF,
排除标准
- •Atypical CIS for a first relapse of multiple sclerosis (extensive myelitis, bilateral retrobulbar optic neuritis immediately)
- •CIS dating more than 4 months (+/- 15 days)
- •Corticotherapy in the last 4 weeks
结局指标
主要结局
severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0
时间窗: At 5 years
次要结局
- Occurrence of a second push(At 5 years)
- Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC)(At 5 years)
- variation of parameters measuring axonal pain / degeneration in MRI(At 5 years)
- variation of parameters measuring axonal pain / degeneration in OCT(At 5 years)
- Occurrence of progression of the EDSS (Expanded Disability Status Scale) score(At 5 years)
研究者
研究点 (1)
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