NCT03278210已完成不适用
National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年4月13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
- 102
- 试验地点
- 1
- 主要终点
- Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
研究概览
简要总结
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.
To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 8 years old
- •intractable focal epilepsy
- •presurgical evaluation or "phase 1" planified
- •with focal EEG activity : more than 3 EEG interictal epileptic events per hour
- •patient and/or legal representant given their written consent for their participation in the study
排除标准
- •MRI contraindication
- •pregnancy
- •uncomfortable prolonged lying position
- •frequent primary or secondary generalised seizure with tonic clonic movements (>2 per week)
- •previous epilepsy surgery
- •important mental retardation
结局指标
主要结局
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
时间窗: 1 year after surgery
A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.
次要结局
- Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG(1 year after surgery)
- Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)(1 year after surgery)
- Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation(1 year after surgery)
- Quality of life score (QOLIE 31)(1 year after surgery)
- Distinction of patients according to the type of their epilepsy: temporal / extra temporal.(1 year after surgery)
研究者
研究点 (1)
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