Clinical trial NCT06244472: A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Concussion
Healthy Volunteers
Keywords: Magnetoencephalographs optically pumped magnetometers (MEG OPM)
Brain activity
Neuroimaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations
timeFrame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
measure: Signal to Noise Ratio comparison between classical MEG and FYNA Research for the auditory stimulations
timeFrame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
measure: Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations
timeFrame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
measure: Signal to Noise Ratio comparison between classical MEG and FYNA Research for the motor stimulations
timeFrame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
measure: Signal to Noise Ratio comparison between classical MEG and FYNA Research for the rest activity
timeFrame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Secondary outcomes:
measure: Correlation of maps of brain activity
timeFrame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
measure: 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).
timeFrame: 5 minutes after the end the recording session
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
city: Lyon
country: France
facility: Centre Orthopédique Paul Santy
Study officials:
affiliation: Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL
name: Julien JUNG, MD
role: PRINCIPAL_INVESTIGATOR
References: