ClinicalTrials.gg
RecruitingNCT06244472DEMAGUSUpdated Jun 1, 2026

A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

An interventional study of Experiment 1: visual and auditory attention task and Experiment 2: language production and rest tasks in Mild Concussion and Healthy Volunteers, sponsored by Hospices Civils de Lyon. Recruiting at 2 sites in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies in Brain Concussion with a site in France — 8 open to participants now, 9 under way, none of them phase 3. Brain Concussion · France.

Planned enrollment
7th of 12
80 · median 85
Started
2025
with 3 others
No phase
12 of 27
3 open now
Registered
21st of 27
by date

Among the 27 studies in Brain Concussion with a site in France, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2025, is one of 12 with no phase, and was the 21st registered.

Brain Concussion

639 studies on the registry are indexed under Brain Concussion; 165 are open to participants now.

Browse Brain Concussion studies →

Open to participants now

8 of the 27 studies in Brain Concussion with a site in France are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 112 Brain Concussion studies recruiting now, 33 (29%) set no upper age limit and 72 (64%) stop at 75 or younger; 24 take children under 18; 38 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 27 studies in Brain Concussion with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Mild Concussion
  • Healthy Volunteers

Browse trials for

Keywords

  • Magnetoencephalographs optically pumped magnetometers (MEG OPM)
  • Brain activity
  • Neuroimaging
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Healthy volunteers:

Inclusion Criteria:

  • Age 18 to 70
  • Strongly motivated to participate to the study
  • Signed 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's refusal to be informed if an abnormality is detected during MEG and MRI scans
  • Subject with common 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'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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Healthy subjects

    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

  • Experimental
    Subjects with concussion

    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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).

  2. 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.

    Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).

  3. 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.

    Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).

  4. 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.

    Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).

  5. 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.

    Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).

Secondary outcomes

  1. Correlation of maps of brain activity

    We will report the spatial correlation between the maps computed with the classical MEG system and the ones computed with the new OPM He4 MEG. The classical MEG will serve as a reference. Healthy volunteers solely.

    Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).

  2. 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).

    The evaluation will be done verbally through a short questionnaire. This questionnaire evaluates the overall comfort of the OPM system with two questions: 1) An evaluation of the overall comfort thanks to a scale with five steps from very uncomfortable to very comfortable and 2) A comparison with the classical MEG system thanks to a 5 steps scale from much less comfortable than the classical MEG system to much more comfortable.

    Time frame: 5 minutes after the end the recording session

07

Study locations

1 of 2 sites recruiting
  • 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Aug 2027, 25 months after the start.

Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 25 months is below that.

Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2024
First posted
Feb 6, 2024
StartActual
Jul 9, 2025
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Jun 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06244472
Responsible party
Sponsor
First posted
Feb 6, 2024
Start date
Jul 9, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Julien JUNG, MD
Contact
julien.jung@chu-lyon.fr
04.72.35.79.00 ext. +33
Denis SCHWARTZ
Contact
denis.schwartz@inserm.fr
04.72.13.89.61 ext. +33
Julien JUNG, MD
principal investigator · Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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