A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

Официальное название

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)

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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).
• Устройство 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.

Первичные конечные точки

• Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).]

Вторичные конечные точки (2)

• Correlation of maps of brain activity [Срок оценки: 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). [Срок оценки: 5 minutes after the end the recording session]

Критерии участия

Healthy volunteers:

Критерии включения

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

Критерии исключения

• 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:

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Werthe — Bron
• Centre Orthopédique Paul Santy — Lyon

Идентификаторы

NCT: NCT06244472 · 69HCL23_0425 · 2023-A01173-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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