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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01173-42 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Experimental | Healthy volunteers aged between 18 and 70 years, without neurological or psychiatric or sleep disorders |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experiment 1: visual and auditory attention task | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (during the intervention, scheduled from 1 to 30 days from inclusion visit V1). |
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Healthy volunteers:
Inclusion Criteria:
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 contraindications to MEG and MRI examination :
Subjects who suffered a mild concussion:
Inclusion Criteria:
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 :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien JUNG, MD | Contact | 04.72.35.79.00 | +33 | julien.jung@chu-lyon.fr |
| Denis SCHWARTZ | Contact | 04.72.13.89.61 | +33 | denis.schwartz@inserm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julien JUNG, MD | Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon | Recruiting | Bron | 69677 | France |
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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.
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| Experiment 2: language production and rest tasks | Device | 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. |
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| Experiment 3: visuo-motor task | Device | 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). |
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| Experiment 4: brain activity at rest | Device | 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. |
|
| 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. | 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. | 5 minutes after the end the recording session |
| Centre Orthopédique Paul Santy | Not yet recruiting | Lyon | 69008 | France |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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