Epileptogenic Network Visualisation With Advanced MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Interest of adding epileptic network radiological analysis in a standard epileptic work-up
研究概览
简要总结
The goal of this clinical trial is to improve non-invasive identification of epileptogenic networks in drug-resistant epileptic patient.
The investigators aim to compare epileptogenic network identification with stereo-EEG (used as glod standard) with the identification of the same network using advanced MRI (rs-fMRI, microstructural analysis of white matter, ...). The main goals are to:
- Compare the accuracy of network identification.
- Analyse the effect of the MRI sequences on candidates selection and target identification.
Participants will already have been selected for stereoEEG and will undergo a supplementary MRI (about 1h) with the additional MRI sequences. Follow-up MRI are scheduled for patient undergoing a second, therapeutic epileptic surgery.
详细描述
Patient identified for SEEG will undergo, prior to the implantation procedure an MRI with the following sequences:
- 3D T1
- rsfMRI
- multishell diffusion
The rsfMRI will be post-processed to delineate the epileptogenic networks based on an Independant Component Analysis (ICA) methods. Once the epileptogenic network(s) has/have been identified, connexion between the different regions will be identified through post-processing of the diffusion using a MSMT-CSD algorithm. Finally, the identified tract between the different region will be quantitatively analysed using different algorithms (NODDI, DIAMOND, MF) to better grasp there integrity.
In a follow-up study, the patients that will later on benefit from a resection or disconnection (i.e. curative surgery) will also have an identical MRI 3 months after the said procedure to evaluate the evolution on the network(s) based on the same criteria.
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
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from drug-resistant epilepsy
- •Patient already selected for SEEG implantation as part of their epileptic networks
排除标准
- •Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)
- •Contra-indication for MRI
研究组 & 干预措施
Single Arm
Single Arm
干预措施: Advanced MRI (Device)
结局指标
主要结局
Interest of adding epileptic network radiological analysis in a standard epileptic work-up
时间窗: Approximately 1 year after the start of phase 3
Analyse the impact on therapeutic and/or diagnostic decision of the network radiological analysis in a standard clinical practice. This impact will be assessed by measuring the change in the type of decision (further work-up, invasive EEG, "curative" surgery, "palliative" surgery or no modification) or the modification in the extent of surgery (more/less electrodes for invasive EEG, more/less tissue targeted with surgery)
Network identification with MRI
时间窗: At the end of phase 1 - expected to be 3 years after first inclusion
Analysis of the anatomical overlap of radiological network (with MRI) and the electrophysiological network (with SEEG) using coregistration and a sublobar analysis. Overlap will be quantified in %.
Prognosis of network targetting with surgery
时间窗: One year after surgery (phase 2)
Analysis of the impact on epileptic outcome in accordance with effect of the surgery on the network. The impact of the surgery on the network will be assessed by coregistration to determine which part of the network has been removed or disconnected. The epileptic outcome will be assessed using the Engel classification
次要结局
- Network regulation with surgery(One year after surgery (phase 2))
- Network quantification(At the end of phase 1 - expected to be 3 years after first inclusion)