Towards a New Generation of Magnetoencephalographs: Evaluation of the FYNA Research (Mag4Health 48 Sensors MEG's Name) System (Full-head Magnetoencephalographs System With Optically Pumped Magnetometers)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations
研究概览
简要总结
The goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography whole head device using optically pumped magnetometers using Helium 4 as the sensitive element (OPM He4) to record brain magnetic activities. The investigators will record 1) healthy subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) athletes who suffered a mild concussion. The main hypothesis is that the OPM magnetoencephalographs (MEG) system will be able to detect brain activity. The secondary hypothesis is that the data recorded with the OPM MEG system will allow to reconstruct maps of the brain activity. To test the main hypothesis, they will compare the signal to noise ratio of brain activities between a classical MEG system and the new OPM He4 MEG. The secondary hypothesis will be tested through a comparison of the maps of brain activity obtained thanks to the data recorded with a classical MEG system and the new OPM He4 MEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Inclusion Criteria:
- •Age 18 to 70
- •Strongly motivated to participate to the study
- •Signed informed consent for the study
排除标准
- •major cognitive deficit and unable to understand the instructions
- •previous neurology or psychiatric or sleep pathologies
- •Woman with a positive pregnancy test during the inclusion.
- •Subjects under guardianship, curatorship or safeguard of justice protection
- •Subjects deprived of their liberty
- •Subject not affiliated to a social security system.
- •Subject's refusal to be informed if an abnormality is detected during MEG and MRI scans
- •Subject with common contraindications to MEG and MRI examination :
- •Metal in the body incompatible with performance of the examination (pacemaker, implantable pump, neurostimulator, cochlear implant, auditory prothesis, metalic prothesis, intracerebral clip, implantable defibrillator, any metalic parts in the brain or upper part of the body, ventriculoperitoneal valve, dental appliance or steel pivot for root canal, ferromagnetic foreign body in the upper part of the upper part of the body)
- •Claustrophobia
- •Subjects who suffered a mild concussion:
- •Inclusion Criteria:
- •Male aged from 18 to 40
- •Strongly motivated to participate to the study
- •Signed informed consent for the study
- •Mild concussion confirmed by the club doctor and a neurologist neurologist in the three weeks preceding the experiment
- •Exclusion Criteria:
- •major cognitive deficit and unability to understand the instructions
- •previous neurology or psychiatric or sleep pathologies except mild concussion
- •Woman with a positive pregnancy test during the inclusion.
- •Subjects under guardianship, curatorship or safeguard of justice protection
- •Subjects deprived of their liberty
- •Subject not affiliated to a social security system
- •Subject's refusal to be informed if an abnormality is detected during MEG and MRI scans
- •Subject with common contraindications to MEG and MRI examination :
- •Metal in the body incompatible with performance of the examination (pacemaker, implantable pump, neurostimulator, cochlear implant, auditory prothesis, metalic prothesis, intracerebral clip, implantable defibrillator, any metalic parts in the brain or upper part of the body, ventriculoperitoneal valve, dental appliance or steel pivot for root canal, ferromagnetic foreign body in the upper part of the upper part of the body)
- •Claustrophobia
研究组 & 干预措施
Healthy subjects
Healthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders
干预措施: Experiment 1: visual and auditory attention task (Device)
Healthy subjects
Healthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders
干预措施: Experiment 2: language production and rest tasks (Device)
Healthy subjects
Healthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders
干预措施: Experiment 3: visuo-motor task (Device)
Subjects with concussion
Male athletes volunteers with concussion aged between 18 and 40 years, without neurological or psychiatric or sleep disorders other than cerebral concussion.
干预措施: Experiment 4: brain activity at rest (Device)
结局指标
主要结局
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations
时间窗: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
The signal to noise ratio of normal (SNR) brain activity following a somesthetic stimulus will be computed with respect to the pre-stimulus baseline -100 milliseconds to -10 milliseconds . We will compare the SNRs obtained with the classical MEG system serving as a reference and the SNRs obtained with the new OPM He4 MEG through the group of healthy volunteers for this given stimulus.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the rest activity
时间窗: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
The signal to noise ratio of normal (SNR) brain activity at rest will be computed with respect to the pre-stimulus baseline -100 milliseconds to -10 milliseconds . We will compare the SNRs obtained with the classical MEG system serving as a reference and the SNRs obtained with the new OPM He4 MEG through the group of male athletes with concussion.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations
时间窗: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
The signal to noise ratio of normal (SNR) brain activity following a visual stimulus will be computed with respect to the pre-stimulus baseline -100 milliseconds to -10 milliseconds. We will compare the SNRs obtained with the classical MEG system serving as a reference and the SNRs obtained with the new OPM He4 MEG through the group of healthy volunteers for this given stimulus.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the motor stimulations
时间窗: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
The signal to noise ratio of normal (SNR) brain activity following a motor stimulus will be computed with respect to the pre-stimulus baseline -100 milliseconds to -10 milliseconds . We will compare the SNRs obtained with the classical MEG system serving as a reference and the SNRs obtained with the new OPM He4 MEG through the group of healthy volunteers for this given stimulus.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the auditory stimulations
时间窗: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
The signal to noise ratio of normal (SNR) brain activity following an auditory stimulus will be computed with respect to the pre-stimulus baseline -100 milliseconds to -10 milliseconds . We will compare the SNRs obtained with the classical MEG system serving as a reference and the SNRs obtained with the new OPM He4 MEG through the group of healthy volunteers for this given stimulus.
次要结局
- Correlation of maps of brain activity(Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).)
- Evaluation of the comfort of the subject during the optically pumped magnetometers (OPM) He4 MEG recordings through a short verbal questionnaire (scores of the absolute and relative comfort scales).(5 minutes after the end the recording session)