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临床试验/NCT03543267
NCT03543267已完成不适用

Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年10月21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
37
试验地点
2
主要终点
to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

研究概览

简要总结

This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

研究设计

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

入排标准

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

入选标准

  • Patients with diagnosis of pharmaco-resistant focal epilepsy
  • Patient candidate for surgery to resect the epileptogenic zone
  • Patients affiliated to a social security scheme or beneficiaries of such a scheme
  • Patients with French as their mother tongue
  • Patients who have given signed informed consent before performing any procedure related to the study.

排除标准

  • Contraindication to performing an MRI:
  • Intellectual disability objectified by a Mini Mental Score (MMS) score <24 in the year preceding inclusion,
  • Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous,
  • Participation in other research protocols underway with exclusion period or in the previous week,
  • Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.

结局指标

主要结局

to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

时间窗: One hour and thirty minutes

The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI

次要结局

未报告次要终点

研究者

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

研究点 (2)

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