跳至主要内容
临床试验/NCT03643016
NCT03643016招募中不适用

Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2019年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
356
试验地点
2
主要终点
Clinical success, defined as seizure free patient without disabling side effect (clinical judgment) at 12-month follow-up

研究概览

简要总结

Every year, thousands of patients worldwide with drug resistant focal epilepsy (DRE) undergo resective brain surgery with the aim of achieving seizure freedom.

Despite technical advances over the last 50 years, the success rate of epilepsy surgery in terms of seizure freedom has not greatly improved, remaining overall at around 50%. Depending on features of individual cases, presurgical evaluation includes a first phase of non-invasive data including video-EEG recordings, magnetoencephalography, structural and functional neuroimaging and neuropsychological evaluation. If these investigations do not allow adequate localization of likely region of seizure organization in the brain (the epileptogenic zone, EZ), then a second invasive phase using intracerebral EEG recording may be necessary (stereoelectroencephalography, SEEG). Interpretation of SEEG remains difficult in many cases, in particular since seizure onset is often characterized by discharges that very rapidly involve several distinct brain regions.

No reliable measuring instrument currently exists to combine the various prognostic factors for a given patient. This leads to great uncertainty on an individual scale in predicting the effects of surgery. The mapping of epileptic networks in patients with DRE is an innovative scientifically-validated and clinically-tested method to significantly improve accuracy of SEEG and presurgical interpretation and guide surgical strategies in patients with DRE. Therefore, the investigators developed the Virtual Epilepsy Patient software. Retrospective study already demonstrated the pertinence of this approach in improving the anatomical mapping of epileptogenic networks. Now, the investigators aim to prospectively demonstrate the role of VEP during presurgical evaluation of DRE patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient or pediatric patient suffering from drug-resistant focal epilepsy.
  • Standardized presurgical evaluation including medical history, scalp video-EEG, 3T MRI (DTI and rsMRI), FDG-PET, Neuropsychological tests.
  • Inpatient in one of the participating centers for recording seizure during long term SEEG-monitoring.

排除标准

  • Epilepsy surgery performed without the requirement of SEEG or contra-indication to epilepsy surgery.

结局指标

主要结局

Clinical success, defined as seizure free patient without disabling side effect (clinical judgment) at 12-month follow-up

时间窗: 12 months

Number of seizure (Engel I)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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