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临床试验/NCT03636789
NCT03636789已完成不适用

Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年10月26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
61
试验地点
6
主要终点
Evaluation of the occurrence of oculomotor disorders

研究概览

简要总结

This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patient must have given his informed consent and signed the consent form.
  • The patient must be affiliated or beneficiary of a health insurance plan.
  • The patient is at least 18 years old (≥) and under 50 years old (≤).
  • Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009)
  • Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years.

排除标准

  • The subject participates in another study.
  • The subject is in an exclusion period determined by a previous study.
  • The subject is under guardianship, curatorship or safeguard of justice.
  • The patient is pregnant or breastfeeding
  • The subject refuses to sign the consent.
  • It is not possible to give the subject informed information.
  • Patient presenting a pathological neurological examination.
  • Patient with visual acuity less than 5/10 or with ocular instability

结局指标

主要结局

Evaluation of the occurrence of oculomotor disorders

时间窗: Day 0

using a video-oculographic recording system

次要结局

  • To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)(Day 0)
  • To identify a correlation between oculomotor disorders and MRI abnormalities.(Day 0)
  • To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder(Day 0)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (6)

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