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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Concussion
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 70
- •Strongly motivated to participate to the study
- •Signed informed consent for the study
Exclusion Criteria
- •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 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:
Outcomes
Primary Outcomes
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)