Evaluation of the FYNA Research OPM MEG Device for Locating Epileptic Foci as Part of Pre-surgical Assessment of Epilepsy
NCT ID: NCT07281222
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2026-03-31
2030-09-30
Brief Summary
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At present, epilepsy surgery cannot cure all patients. Since the prognosis for surgery depends primarily on the ability to delineate the epileptogenic zone, it is essential to develop new diagnostic approaches that can accurately detect epileptic foci.
MEG (magnetoencephalography) is a non-invasive brain mapping technique based on the magnetic fields created by neuronal activity. Numerous studies have shown that it is a highly effective technique for locating epileptic foci, and more accurate than EEG. However, MEG remains relatively uncommon (three centers in France) because current conventional systems (MEG SQUID) are difficult to use, expensive, require significant structural constraints for installation, and are not very sensitive (sensors are distant from the scalp).
Mag4Health has developed a new MEG device, the "MEG FYNA Research", which records brain magnetic activity using 48 or 96 sensors (4He optical pumping magnetometers, or "OPMs"). Compared to conventional MEG (SQUID MEG), this OPM MEG technology is more compact, less expensive, more sensitive, and allows the sensors to be placed directly on the scalp.
The EPI-OPM study is a prospective, uncontrolled, bicenter clinical investigation that aims to evaluate the diagnostic performance of this device.
The main objective is to assess the value of the OPM MEG device for localizing the epileptogenic zone compared to the reference method in epileptic patients undergoing epilepsy surgery.
Patients (children and adults) will be enrolled at the Lyon University Hospital and the Marseille University Hospital.
Each patient will undergo an OPM MEG examination and a SQUID MEG examination (SQUID MEG only for patients in Lyon), in addition to the clinical procedures performed as part of routine care: intracranial EEG recording (SEEG) and MRI if necessary, followed by surgery to resect the epileptic focus.
The performance of the OPM MEG device in locating epileptic foci will be validated by surgical results and invasive EEG recordings. The localization of epileptic foci using the OPM MEG system will be compared with that obtained using the SQUID MEG system (conventional MEG) and other pre-surgical assessment tests carried out as part of routine care. Finally, we will describe tolerance to the recordings and assess overall comfort and feasibility using appropriate questionnaires.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Drug-resistant epilepsy patients who are candidates for epilepsy surgery
Patients are drug-resistant epilepsy who are candidates for whom the following are decided and planned:
either 1) a surgical procedure to resect the epileptogenic zone without prior intracranial EEG recording or 2) intracranial EEG recording necessary prior to a possible cortical resection procedure They will undergo two imaging examinations specific to the study: OPM MEG examination with the FYNA Research device evaluated in this study and a conventional SQUID MEG examination. If necessary (not already performed/available), the will undergo a brain MRI during a single visit.
MEG OPM
The OPM MEG sensor (FYNA Research device) is a new sensor technology for MEG (magnetoencephalography). It consists of 48 detectors (helium-4 magnetometers) that are positioned on the patient's head using a support system that can be adjusted to fit the size of their head. The patient goes to the MEG center at CERMEP (patients included in Lyon) or INS (patients included in Marseille), changes clothes, and removes any makeup. Metal-free clothing designed for MEG is provided. The tracking coils are put in place. The patient is then placed in the MEG, and their positioning and comfort are checked again.
The OPM MEG acquisition takes about 60 minutes.
MEG SQUID
The MEG SQUID is the classical MEG (magnetoencephalography). It consists of a set of sensors placed in a rigid helmet, in contact with the head. The patient goes to the MEG center at CERMEP (patients included in Lyon) or INS (patients included in Marseille), changes clothes, and removes any makeup. Metal-free clothing designed for MEG is provided. The tracking coils are put in place. The patient is then placed in the MEG, and their positioning and comfort are checked again.
The OPM MEG acquisition takes about 60 minutes.
Interventions
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MEG OPM
The OPM MEG sensor (FYNA Research device) is a new sensor technology for MEG (magnetoencephalography). It consists of 48 detectors (helium-4 magnetometers) that are positioned on the patient's head using a support system that can be adjusted to fit the size of their head. The patient goes to the MEG center at CERMEP (patients included in Lyon) or INS (patients included in Marseille), changes clothes, and removes any makeup. Metal-free clothing designed for MEG is provided. The tracking coils are put in place. The patient is then placed in the MEG, and their positioning and comfort are checked again.
The OPM MEG acquisition takes about 60 minutes.
MEG SQUID
The MEG SQUID is the classical MEG (magnetoencephalography). It consists of a set of sensors placed in a rigid helmet, in contact with the head. The patient goes to the MEG center at CERMEP (patients included in Lyon) or INS (patients included in Marseille), changes clothes, and removes any makeup. Metal-free clothing designed for MEG is provided. The tracking coils are put in place. The patient is then placed in the MEG, and their positioning and comfort are checked again.
The OPM MEG acquisition takes about 60 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Patients suffering from partial epilepsy that has been developing for at least 2 years, drug-resistant, regardless of the presumed topographical origin or suggested cause (lesional with or without MRI abnormality) and for whom the following have been decided and planned:
either i) a surgical procedure to resect the epileptogenic zone without prior intracranial EEG recording or ii) intracranial EEG recording necessary before a possible cortical resection procedure
3. Patients who have undergone routine prolonged scalp video EEG recording showing interictal paroxysmal abnormalities
4. Patients motivated to participate effectively in the project
5. Patients who have signed an informed consent form to participate in the study
Exclusion Criteria
2. Patients with contraindications common to MEG and MRI examinations:
* Metal in the body that is incompatible with the examination (pacemaker, implanted pump including insulin pump, neurostimulator, cochlear implants or other hearing devices, metal prosthesis, intracerebral/surgical clips for aneurysms, implantable defibrillators, ferromagnetic foreign bodies in the eyes or brain in the upper body, ventriculoperitoneal neurosurgical shunt valves, dental braces or steel pivots for dental root canals, ferromagnetic foreign bodies in the upper body)
* Claustrophobia
3. Pregnant women, breastfeeding women, or women who have given birth within the last 6 months.
4. Patients under guardianship, curatorship, or judicial protection
5. Patients deprived of their liberty
6. Patients not affiliated with a social security system or beneficiaries of such a system
6 Years
65 Years
ALL
No
Sponsors
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MAG4Health
UNKNOWN
Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Julien JUNG, Professor
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Denis SCHWARTZ, PhD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, Service Explorations Fonctionnelles Pédiatriques
Bron, , France
Hôpital Neurologique, Hospices Civils de Lyon, Service Explorations Fonctionnelles Neurologiques et Epileptologie
Bron, , France
Hôpital de la Timone, AP-HM Service d'Epileptologie et Rythmologie Cérébrale
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A02262-47
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL24_0886
Identifier Type: -
Identifier Source: org_study_id