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