RecruitingNot ApplicableNCT06244472

A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

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)

Sponsor

Hospices Civils de Lyon

Enrollment

80 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Mild Concussion

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of brain scanner called an OPM-MEG (optically pumped magnetometer magnetoencephalograph) — a wearable helmet-like device that measures tiny magnetic fields produced by brain activity. It is being tested on healthy volunteers to see if it works as well or better than conventional brain imaging for capturing fast brain signals. **You may be eligible if...** - You are a healthy adult between 18 and 70 years old - You are motivated to participate and can follow study instructions - You are able to give informed consent **You may NOT be eligible if...** - You have a history of neurological or psychiatric disorders, or sleep disorders - You are pregnant - You have metal implants in your body (pacemaker, cochlear implant, metal prosthesis, brain clips, neurostimulator, etc.) - You are not affiliated with a social security system - You are under legal guardianship or detained Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperiment 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.

DEVICEExperiment 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.

DEVICEExperiment 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).

DEVICEExperiment 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.