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Clinical Trials in France / NCT06244472
Recruiting Not applicable

A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

NCT06244472 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Not applicable
Started
2025-07-09
Last updated
2026-06-01

Condition(s) studied

Mild ConcussionHealthy Volunteers

Investigational drug(s) / intervention(s)

Experiment 1: visual and auditory attention taskExperiment 2: language production and rest tasksExperiment 3: visuo-motor taskExperiment 4: brain activity at rest

Experiment 1: visual and auditory attention task: We will use the FYNA Research system on 20 healthy volunteers with a visual and auditory attention task to evaluate the system's performance in recording brain signals complex frequency content.

Experiment 2: language production and rest tasks: We will use the FYNA Research system on 20 healthy healthy volunteers with a language production task to assess the system's functional mapping capabilities and a resting task to assess the system's ability to identify resting networks.

Experiment 3: visuo-motor task: We will use the FYNA Research system in 20 healthy volunteers with a visuo-motor task to evaluate the system's performance in recording brain signals when the subject moves, inducing perturbations that affect the classical system (loss of spatial precision) and the FYNA Research system (low-frequency artifacts).

Experiment 4: brain activity at rest: We will be using the FYNA Research system on 20 concussed male athletes volunteers to assess the system's ability to detect modulations in the frequency content of resting brain activity.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Healthy volunteers: 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'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

Primary outcome measure(s)

  • Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations — 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 auditory stimulations — 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.
  • Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations — 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 motor stimulations — 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 rest activity — 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.

Trial sites (2)

FacilityCityRegionStatus
Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon Bron France Recruiting
Centre Orthopédique Paul Santy Lyon France Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244472 on ClinicalTrials.gov ↗ ← All trials in France