Evaluation of the FYNA Research OPM MEG Device for Locating Epileptic Foci as Part of Pre-surgical Assessment of Epilepsy

Sponsor
Hospices Civils de Lyon
Study ID
NCT07281222
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MEG OPM — DEVICE
    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 — DEVICE
    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.

Study Details

The success of epilepsy surgery depends largely on the reliability of the preoperative localization of the epileptogenic zone. The conventional method for determining the area to be removed is based on a complex assessment involving an electroencephalogram (EEG) coupled with simultaneous video recording of seizures (video SEEG), a brain MRI, and a fluorodeoxyglucose positron emission tomography scan (PET-FDG). 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.

Key Dates

Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.

Primary Outcome Measure

Percentage of cases in which the location of epileptic foci identified by MEG OPM confirmed the location identified by pre-surgical assessment (EEG, SEEG, MRI, PET-FDG) when surgery was successful, one year after its completion (composite outcome) [ Time Frame: 1 year after surgery (18 months after inclusion) ]

Central Contacts

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