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临床试验/NCT04694313
NCT04694313已完成不适用

Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Signal to noise ratio visible on the sensors

研究概览

简要总结

This research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers.

The measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. It is the only one, along with EEG and related techniques, to provide data related to the speed of the brain. MEG, by virtue of the properties of magnetic fields, has a greater potential than EEG for the detection and localization of the neuronal sources which cause it.

The MEG sensors used until now use Superconducting Quantum Interference Devices (SQUID) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost.

The alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type.

This preliminary study proposes to compare SQUID sensors with MPO He4 sensors for their ability to detect abnormal activities recorded in epileptic patients. Measurements that cannot be recorded simultaneously Two types of measurement will be compared with the reference that constitutes in-depth recording (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

The expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of SQUIDs.

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

入选标准

  • Adult patient (≥ 18 years old)
  • Patient with drug-resistant focal epilepsy, undergoing SEEG exploration
  • Healthy subject, devoid of central neurological pathology, major ((≥ 18 years)
  • Patient or healthy subject capable of giving informed consent for the study

排除标准

  • MEG "incompatible" healthy patients or volunteers.
  • Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible.
  • Patients or healthy volunteers who cannot stand standing still for a few minutes.
  • Pregnant or breastfeeding women
  • Adults under guardianship or under legal protection
  • People deprived of their liberty
  • People who have not signed the informed consent

研究组 & 干预措施

OPM

Experimental

Two types of measurement will be compared (SQUID and OPM) with the reference that constitutes the in-depth recordings (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

干预措施: OPM (Device)

结局指标

主要结局

Signal to noise ratio visible on the sensors

时间窗: Visit 0 at month 0

Interictal peaks or oscillations in different frequency bands (gamma, ripples, fast ripples)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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