A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

Healthy Volunteers Clinical Trial

— DEMAGUS  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244472
• Other study ID #: 69HCL23_0425
• Secondary ID: 2023-A01173-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: March 15, 2026

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Julien JUNG, MD
• Phone: 04.72.35.79.00
• Email: julien.jung[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 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 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

Related Conditions & MeSH terms

• Brain Concussion
• Healthy Volunteers
• Mild Concussion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon	Bron
France	Centre Orthopédique Paul Santy	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations	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.	Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Primary	Signal to Noise Ratio comparison between classical MEG and FYNA Research for the auditory stimulations	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.	Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Primary	Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations	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.	Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Primary	Signal to Noise Ratio comparison between classical MEG and FYNA Research for the motor stimulations	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.	Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Primary	Signal to Noise Ratio comparison between classical MEG and FYNA Research for the rest activity	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.	Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Secondary	Correlation of maps of brain activity	We will report the spatial correlation between the maps computed with the classical MEG system and the ones computed with the new OPM He4 MEG. The classical MEG will serve as a reference.; Healthy volunteers solely.	Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Secondary	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).	The evaluation will be done verbally through a short questionnaire. This questionnaire evaluates the overall comfort of the OPM system with two questions: 1) An evaluation of the overall comfort thanks to a scale with five steps from very uncomfortable to very comfortable and 2) A comparison with the classical MEG system thanks to a 5 steps scale from much less comfortable than the classical MEG system to much more comfortable.	5 minutes after the end the recording session