NCT01090934已完成不适用
Etude de la Performance Diagnostique de l'EEG-Haute Résolution Sur la Localisation de la Zone épileptogène Pour le Traitement Chirurgical Des épilepsies Partielles Pharmaco-résistantes
Central Hospital, Nancy, France4 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2009年10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
- 115
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method)
研究概览
简要总结
Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
- •Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
- •full informed consent of the patient (or of his/ her legal representative)
- •15 year or older patient
排除标准
- •contraindication to cortectomy
- •contraindication to depth-EEG
- •indication of epilepsy surgery without depth-EEG monitoring
- •high grade glioma, arterio-veinous malformations
- •pregnancy
- •history of severe cardio-vascular event (coronaropathy, stroke)
结局指标
主要结局
Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method)
时间窗: 3 years
results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG
次要结局
- inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.(3 years)
- sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision(3 years)
研究者
louis maillard
Dr Louis MAILLARD
Central Hospital, Nancy, France
研究点 (4)
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