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临床试验/NCT05254730
NCT05254730招募中不适用

Using Micro-filaments to Detect "fast Ripples" and Improve the Identification of the Epileptogenic Zone

Adrien Peyrache2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年9月1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
45
试验地点
2
主要终点
evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes

研究概览

简要总结

record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy

详细描述

This study would improve the localization of the epileptogenic zone and reduce the overall duration of monitoring, especially in patients who do not experience a sufficient number of seizures during the implantation period. In addition, it would be possible to use micro-electrodes and propose a better surgical treatment to some patients whose preliminary assessment with macro-electrodes has not provided significant results. Finally, the data collected during this study will help us to further understand pathological brain activity and to describe the neuronal circuitry that gives rise to cortical signals and the relationships between them (from spindles to high frequency oscillations).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • inclusion criteria is determined based on the clinical diagnosis of the refractory epilepsy and the admissibility of the patient for the stereoelectroencephalography (sEEG) procedure

排除标准

  • severe psychiatric disorders,
  • severe agitation during their crisis
  • contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
  • contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
  • anti thrombotic ongoing treatment.

结局指标

主要结局

evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes

时间窗: 1 week after implant

sum of number of single units recorded and the number of fast ripples (FRs)

次要结局

  • Efficiency of microelectrodes compared to macroelectrodes(10 days after implant)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Adrien Peyrache

Associate Professor

McGill University

研究点 (2)

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