跳至主要内容
临床试验/NCT03738072
NCT03738072招募中不适用

A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月14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
20
试验地点
2
主要终点
Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition

研究概览

简要总结

Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

详细描述

Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. However the efficiency of these stimulations can be questioned and could potentially be improved. Indeed, only two typical frequencies are commonly used in our epilepsy centre, 1Hz and 50Hz, without clear clinical or scientific justification for these specific frequencies.

This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. We will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). The choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe).

The protocol will be proposed to all patients undergoing a stereo-electro-encephalography (SEEG) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. The efficiency will be assessed as any epileptic event, recorded in the intracerebral EEG or symptom induced by the stimulations. This project will last 36 months. 20 patients will be included.

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

入选标准

  • all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old.

排除标准

  • usual excluding criteria for a SEEG.

结局指标

主要结局

Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition

时间窗: 22 days after implantation of electrode

Comparison for each patient of the index of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect over the total number of stimulations) for each condition (standard clinical stimulations condition vs research stimulations condition).

次要结局

  • percentage change in the neuronal discharge rate(30 second after stimulation)
  • efficient stimulation for each frequency of stimulation(22 days after implantation of electrode)
  • efficient stimulation for each type of brain area stimulated(22 days after implantation of electrode)
  • percentage change in the neuronal discharge rate for stimic stimulation condition(30 second after stimulation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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