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临床试验/NCT05335187
NCT05335187招募中不适用

Hybrid Micro-macro Electrodes to Record the Activity of Single Neurons During Seizures in Patients Who Suffer From Epilepsy

Pierre Mégevand4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
4
主要终点
Adverse events (safety outcome)

研究概览

简要总结

The aim of the MicroEPI study is to know whether it is possible to use safely a medical device (a micro-electrode) that allows recording the activity of neurons in the human brain. Patients who suffer from drug-resistant epilepsy and who are candidates to epilepsy surgery to alleviate their condition sometimes require the implantation of intracranial EEG electrodes for a few weeks, in order to determine as best as possible which region of the brain to operate on. In the MicroEPI study, some of these electrodes will also comprise micro-electrodes, allowing us to record the activity of the patients' neurons during their epileptic seizures.

详细描述

Epilepsy is a common disease of the brain that can be severe or even cause death. What we call epilepsy is a tendency to suffer from epileptic seizures, which themselves consist in symptoms (e.g. loss of consciousness, involuntary movements, abnormal sensations like hallucinations) caused by abnormally intense or synchronized activity of the brain's neurons. However, we still understand very poorly what exactly goes on at the level of neurons in the human brain during an epileptic seizure. This knowledge gap is due to the fact that the brain's neurons are very small structures and are very well protected by the skull, and are therefore hard to study in human beings. Gaining a better understanding of how neuronal activity goes awry during epileptic seizures could lead to better ways to treat this disease.

In the MicroEPI study, a medical device called micro-macro electrode (MME), manufactured by the company Dixi Medical (France), will be implanted in the brain of patients who must anyway receive intracranial EEG electrodes. These MME electrodes will replace one or a handful of conventional intracranial EEG electrodes. The implantation surgery will be performed in the operating room, under general anesthesia, by an experienced neurosurgeon. The electrodes will remain implanted for 2 to 4 weeks, with the exact duration depending on the time required for the clinical team caring for the patient to collect enough information on the patient's epilepsy. During the entire duration of the electrodes' implantation, the patient will remain hospitalized, and the electrical signals from their brain will be recorded continuously. At the end of this period, the electrodes will be explanted in the operating room. The safety of the MME electrodes, expressed in terms of the number of adverse events attributable to the MME, will be compared to current data on the safety of conventional intracranial EEG electrodes. The performance of the MME electrodes, in terms of the number of recorded neurons, will also be measured.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Patient 18 years old or older suffering from drug-resistant focal epilepsy.
  • Candidate for epilepsy surgery.
  • Requires evaluation with intracranial stereo-EEG electrodes.
  • Able and willing to provide informed consent.

排除标准

  • Any acute infection (e.g. fever, throat infection).
  • Skin or scalp infection over the implantation site.
  • Thin or fragile skull bones, which would prevent stereo-EEG electrodes from being anchored safely.
  • Increased risk of infections, either from a medical condition or from immunosuppressant medication.
  • Increased risk of bleeding, either from a medical condition or from antiplatelet or anticoagulant medication.
  • Severe concomitant medical disease (including, but not limited to, cardiovascular, respiratory, renal or hepatic disease).
  • Severe concomitant psychiatric disease or major psychological distress.
  • Women who are pregnant or breastfeeding during the study.
  • Patients who have an implanted stimulation device (e.g. pacemaker, defibrillator, neurostimulator).

研究组 & 干预措施

micro-macro electrode

Experimental

In this single-arm, open-label study, all patients receive one or a handful of micro-macro electrode (MME) in place of conventional intracranial EEG electrodes.

干预措施: micro-macro electrode implantation (Device)

结局指标

主要结局

Adverse events (safety outcome)

时间窗: approximately 30 days

Number of adverse and severe adverse events possibly, probably or definitely related to the study device

次要结局

  • Device malfunctions (performance outcome 1)(approximately 30 days)
  • Number of neurons recorded (performance outcome 2)(approximately 30 days)

研究者

发起方
Pierre Mégevand
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Mégevand

Assistant Professor

University of Geneva, Switzerland

研究点 (4)

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