Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Connectivity maps
研究概览
简要总结
Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population.
Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy.
It is in this context that EPISTIM is interesting, and its aims isb a better electrophysiology delimiting of cortical networks that imply the genesis of seizures with the aim to improove surgery results.
This study will rely on the intracerebral records and on corticales electrical stimulation as they are currently routinely used by epileptic patients candidates for surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 5 to 65 years (L1121-7 L1122 2 CSP), including legally protected or unable to give his consent (L1121-8 CSP).
- •Written approval of inclusion in the study from the patient or his legal representative.
- •Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.
排除标准
- •Patient under 5 years.
- •Patient over 65 years.
- •Pregnant or breastfeeeding women (L1121-5 CSP).
- •Patient deprived of liberty as a result of a judicial or administrative decision (L1121-6 CSP).
- •Patients over 18 years unable to give their free consent and not subject to a legal protection order.
结局指标
主要结局
Connectivity maps
时间窗: up to 10 min
Connectivity maps : calculated for each site stimulated at low-frequency.
Visual analysis
时间窗: up to one hour
Visual analysis : in order to define the level of cortical resections.
Epileptogenic maps
时间窗: up to 10 min
Epileptogenic maps : calculated for each crisis and for all crisis in general.
MRI
时间窗: up to one hour
Post-operative evaluation : in order to assess the extent of resection. MRI : 3D-T1
次要结局
未报告次要终点