A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

NCT ID: NCT06244472

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-09
• Study Completion Date: 2027-08-31

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.

Conditions

Mild Concussion; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Healthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders

Group Type: EXPERIMENTAL

Experiment 1: visual and auditory attention task

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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).

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.

Group Type: EXPERIMENTAL

Experiment 4: brain activity at rest

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 to 70
• Strongly motivated to participate to the study
• Signed informed consent for the study

• 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 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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien JUNG, MD

Role: PRINCIPAL_INVESTIGATOR

Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL

Locations

Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

Bron, , France

Site Status: RECRUITING

Centre Orthopédique Paul Santy

Lyon, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Julien JUNG, MD

Role: CONTACT

julien.jung@chu-lyon.fr

04.72.35.79.00 ext. +33

Denis SCHWARTZ

Role: CONTACT

denis.schwartz@inserm.fr

04.72.13.89.61 ext. +33

Facility Contacts

Julien JUNG, MD

Role: primary

julien.jung@chu-lyon.fr

04 72 35 79 00 ext. +33

Romain LOURSAC, MD

Role: primary

loursacromain@gmail.com

04 37 53 00 17 ext. +33

Other Identifiers

2023-A01173-42

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_0425

Identifier Type: -

Identifier Source: org_study_id