What is the Added Clinical Value of an Automated EEG Analysis Program With Electrical Source Localization (EPILOG PreOp®) as Part of the Pre-surgical Assessment of Non-lesional Refractory Epilepsy?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Quantification of Epilog+ driven changes of management plan
研究概览
简要总结
Drug resistant epilepsy is best managed by surgery. The goal of presurgical evalution is to correctly identify the epileptogenic zone, defined by the extent of cortical tissue that needs to be removed is order to achieve seizure freedom. When no causative lesion is identified, careful study of interictal activity is mandatory. Complementary analysis methods exist, designed to identify the source of electrical activity recorded with surface electro-encephalogram. While results are interesting in retrospective studies, the real clinical added value needs to be demonstrated with prospective studies. The company Epilog (Epilog, Ghent, Belgium) offers, with EPILOG PreOp®, a long-term EEG analysis to automatically detect epileptiform activity, combined with an estimation of the electrical source localization using a sLORETA inverse solution model. We will propose the EPILOG PreOp analysis to refractory epileptic patients with non-contributive cerebral imaging, under presurgical evaluation. By comparing the therapeutic decision with and without knowledge of the results of EPILOG PreOp®, we will establish the added clinical value of EPILOG PreOp®.
详细描述
Saint-Luc University Hospital (CUSL) are the sponsor of the study. The study is bi-centric, in collaboration with the William Lennox Neurological Hospital Center (CHNWL).
Will be included prospectively the first thirty patients with refractory focal epilepsy being evaluated at CUSL or CHNWL between for surgery, and for whom the cerebral MRI 3 Tesla (3T) did not show any obvious causal lesion.
The pre-surgical evaluation includes (standard of care - SOC):
- EEG-video scalp monitoring (SOC)
- MRI 3Tesla (SOC)
- PET scan FDG (SOC)
- neuropsychological assessment (SOC) MRI examination will be reviewed by an experienced neuroradiologist at CUSL (SOC).
The automated EEG analysis and electrical source localization with EPILOG PreOp® (non-SOC) will be carried out by Epilog (Epilog, Ghent, Belgium), blind to the rest of the workup. The costs of this analysis are 250 € / patient and will be covered by a clinical research fund. If the patient is referred by the CUSL, the costs are charged to account 830 E. If the patient is referred by the CHNWL, the costs are charged to a local scientific account.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Investigator has no access to Epilog Preop result during first case description.
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •drug resistant epilepsy under presurgical evaluation
- •non lesional 3Tesla MRI scan
- •epileptic seizure(s) recorded during video-EEG monitoring
排除标准
- •patient does not agree for follow-up during 6 months
- •patient has an obvious causal lesion on MRI scan
研究组 & 干预措施
Epilog Preop
patients receive Epilog preop analysis
干预措施: electrical source imaging (Diagnostic Test)
结局指标
主要结局
Quantification of Epilog+ driven changes of management plan
时间窗: up to 6 months after recruitment
Descriptive analysis of population with results from Epilog Preop analysis that changed initial clinical decision (total number of patients, type management plan modification)
次要结局
- Sensitivity and specificity of Epilog+ compared to pathology(up to 24 months after recruitment)
- Sensitivity and specificity of Epilog+ compared to resection zone(up to 24 months after recruitment)
- Sensitivity and specificity of Epilog+ compared to seizure outcome(up to 24 months after recruitment)