Mild ConcussionDEMAGUSNCT06244472
A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging
A study testing Experiment 1: visual and auditory attention task, Experiment 2: language production and rest tasks and Experiment 3: visuo-motor task in people with Mild Concussion and Healthy Volunteers, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Concussion, Healthy Volunteers
- What is being tested?
- Experiment 1: visual and auditory attention task, Experiment 2: language production and rest tasks and Experiment 3: visuo-motor task
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 70
- Strongly motivated to participate to the study
- Signed informed consent for the study
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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:
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Bron, 69677
Julien JUNG, MD, 04 72 35 79 00 ext. +33, julien.jung@chu-lyon.fr
- Not yet recruiting
Centre Orthopédique Paul Santy
Lyon, 69008
Romain LOURSAC, MD, 04 37 53 00 17 ext. +33, loursacromain@gmail.com
About this study
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)
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
- Being tested
- Experiment 1: visual and auditory attention task, Experiment 2: language production and rest tasks, Experiment 3: visuo-motor task, Experiment 4: brain activity at rest
- Keywords
- Magnetoencephalographs optically pumped magnetometers (MEG OPM), Brain activity, Neuroimaging
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiment 1: visual and auditory attention taskDevice
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.
Experiment 2: language production and rest tasksDevice
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.
Experiment 3: visuo-motor taskDevice
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).
Experiment 4: brain activity at restDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Healthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders Receives: Device: Experiment 1: visual and auditory attention task; Device: Experiment 2: language production and rest tasks; Device: Experiment 3: visuo-motor task |
| Subjects with concussion | Experimental | Male athletes volunteers with concussion aged between 18 and 40 years, without neurological or psychiatric or sleep disorders other than cerebral concussion. Receives: Device: Experiment 4: brain activity at rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
Secondary outcomes (2)
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.
Measured: 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).
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.
Measured: 5 minutes after the end the recording session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start9 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild ConcussionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien JUNG, MD, Principal investigator, Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244472
- Sponsor's protocol ID
- 69HCL23_0425
- Other IDs
- 2023-A01173-42
- Acronym
- DEMAGUS
- Status last verified
- May 2026
- First submitted
- 5 Jan 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06244472
- Acronym / sponsor ID
- DEMAGUS / 69HCL23_0425
- Conditions
- Mild Concussion, Healthy Volunteers
- Keywords
- Magnetoencephalographs optically pumped magnetometers (MEG OPM), Brain activity, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: Experiment 1: visual and auditory attention task, Device: Experiment 2: language production and rest tasks, Device: Experiment 3: visuo-motor taskHealthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders |
| Subjects with concussion | Experimental | Device: Experiment 4: brain activity at restMale athletes volunteers with concussion aged between 18 and 40 years, without neurological or psychiatric or sleep disorders other than cerebral concussion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 70
- Strongly motivated to participate to the study
- Signed informed consent for the study
- Male aged from 18 to 40
- Strongly motivated to participate to the study
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiment 1: visual and auditory attention taskWe 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 | Healthy subjects |
| Experiment 2: language production and rest tasksWe 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 | Healthy subjects |
| Experiment 3: visuo-motor taskWe 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 | Healthy subjects |
| Experiment 4: brain activity at restWe 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. | Device | Subjects with concussion |
Primary outcome
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations
Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
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.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the auditory stimulations
Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
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.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the somesthesia stimulations
Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
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.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the motor stimulations
Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
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.
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the rest activity
Time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).
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.
2 secondary outcomes
Correlation of maps of brain activity
Time frame: 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).
Time frame: 5 minutes after the end the recording session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien JUNG, MD principal investigator
Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiment 1: visual and auditory attention task, Experiment 2: language production and rest tasks and Experiment 3: visuo-motor task in people with Mild Concussion and Healthy Volunteers, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien JUNG, MD (04.72.35.79.00 ext. +33, julien.jung@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal to Noise Ratio comparison between classical MEG and FYNA Research for the visual stimulations (time frame: Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.