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临床试验/NCT04653012
NCT04653012招募中不适用

Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Identification of single unit changes at seizure emergence

研究概览

简要总结

The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.

The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with focal drug-resistant epilepsy
  • Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital.
  • Patients who have been informed and provided written informed consent to take part in the study

排除标准

  • Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
  • Pregnant or parturient woman
  • Breastfeeding woman
  • Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)

结局指标

主要结局

Identification of single unit changes at seizure emergence

时间窗: Whole duration of the clinical inverstigation, until 4 weeks

In order to identify biomarkers of epileptic seizures we will study single neuron activities (firing rate) using spike sorting at different time periods (before, during and after seizures and during interictal periods) We expect to observe significant changes in firing rate across the different time periods.

Identification of local field potential (LFP) changes at seizure emergence

时间窗: Whole duration of the clinical inverstigation, until 4 weeks

In order to identify biomarkers of epileptic seizures we will study LFP power using time frequency analysis at different time periods (before, during and after seizures and during interictal periods) We expect to observe significant changes in LFP power across the different time periods.

次要结局

  • Identification of single unit changes during physiological brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
  • Identification of LFP power changes during physiological brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
  • Multilevel study of brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
  • Comparison of single unit activity before seizure according to brain localization(Whole duration ofthe clinical inverstigation, until 4 weeks)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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