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临床试验/NCT04615637
NCT04615637Unknown不适用

Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Signal to Noise Ratio of the recorded brain activities

研究概览

简要总结

Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers:
  • Right handed
  • Medical insurance
  • Strongly motivated to participate to the study
  • Signed informed consent for the study
  • No previous neurology or psychiatric pathologies
  • No major cognitive deficit and able to understand the instructions
  • Right handed
  • Medical insurance
  • Strongly motivated to participate to the study
  • Signed informed consent for the study
  • No previous neurology or psychiatric pathologies (except epilepsy)
  • Epilepsy evolving during at least two years
  • No major cognitive deficit and able to understand the instructions

排除标准

  • Volunteers:
  • Age < 18 years or > 60
  • previous neurology or psychiatric pathologies
  • Child bearing women
  • Subject having one of the following mettalic parts :
  • (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
  • Claustrophobia Woman with a positive pregnancy test during the inclusion.
  • Age < 18 years or > 60
  • previous neurology or psychiatric pathologies except epilepsy
  • Child bearing women
  • Subject having one of the following mettalic parts :
  • (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
  • Claustrophobia Woman with a positive pregnancy test during the inclusion.

结局指标

主要结局

Signal to Noise Ratio of the recorded brain activities

时间窗: 1 month

Volunteers: The signal to noise ratio of normal brain activity following a stimulus will be computed with respect to the pre-stimulus baseline -100ms to -10 ms. Epileptic patient: The signal to noise ratio of abnormal epileptic brain activity will be computed with respect to a 100 ms baseline not containing any abnormal activity.

次要结局

  • Signal to Noise Ratio of pre-frontal auditory activity(one month)
  • Signal to Noise Ratio of high frequency epileptic activity(one month.)
  • Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary(5 minutes after the end the recording session)
  • Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary(5 minutes after the end of each recording session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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