A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

NCT06244472 | Recruiting

• 2 other identifiers: 69HCL23_04252023-A01173-42
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

Magnetoencephalographs optically pumped magnetometers (MEG OPM); Brain activity; Neuroimaging

Outcome Measures

Primary Outcomes (5)

• 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).

• 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).

• 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).

• 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).

• 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 Outcomes (2)

• 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

Study Arms (2)

Healthy subjects

EXPERIMENTAL

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

Device: Experiment 1: visual and auditory attention task; Device: Experiment 2: language production and rest tasks; Device: Experiment 3: visuo-motor task

Subjects with concussion

EXPERIMENTAL

Male athletes volunteers with concussion aged between 18 and 40 years, without neurological or psychiatric or sleep disorders other than cerebral concussion.

Device: Experiment 4: brain activity at rest

Interventions

Experiment 1: visual and auditory attention task 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.

Healthy subjects

Experiment 2: language production and rest tasks 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.

Healthy subjects

Experiment 3: visuo-motor task 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).

Healthy subjects

Experiment 4: brain activity at rest 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.

Subjects with concussion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• major cognitive deficit and unable to understand the instructions
• previous neurology or psychiatric or sleep pathologies
• 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:
• 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
• major cognitive deficit and unability to understand the instructions
• previous neurology or psychiatric or sleep pathologies except mild concussion

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

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

Bron, 69677, France

RECRUITING

Centre Orthopédique Paul Santy

Lyon, 69008, France

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Julien JUNG, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien JUNG, MD

CONTACT

04.72.35.79.00; julien.jung@chu-lyon.fr

Denis SCHWARTZ

CONTACT

04.72.13.89.61; denis.schwartz@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In healthy subjects, we will test our hypotheses in three independent experiments (20 subjects per experiment), covering an important part of the current field of use of MEG in auditory, visual, motor and somaesthetic modalities. Subjects will have the opportunity to participate in one, two or all three experiments, as they wish. In adults with mild traumatic brain injury, we will test our hypotheses using resting-state recording (20 subjects). For all the tasks, we will carry out an acquisition with the 275-sensor SQUID (Superconducting Quantum Interference Devices) MEG system from the MEG department at CERMEP (Centre d'Etude et de Recherche Multimodal Et Pluridisciplinaire) in Lyon, and a similar acquisition with the FYNA Research system. If the subject has no anatomical MRI (Magnetic resonance imaging), a 3D anatomical MRI (15-minute acquisition time) on a 1.5 Tesla MRI will be performed after the last MEG examination.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 6, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)