NCT06244472

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.
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).
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.

Timeline

• Start date: 2025-07-09
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2024-02-06
• Last updated: 2025-07-15

Locations

2 sites across 1 country: France