NCT03893916 MEG Versus EEG HR for the Localization of the Epileptogenic Zone as Part of the Pre-surgical Assessment of Epilepsy
| NCT ID | NCT03893916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Drug-resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-10-25 |
| Primary Completion | 2029-04-25 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2019-10-25 with a primary completion date of 2029-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Drug-resistant partial epilepsies are disabling diseases for which surgical treatment may be indicated. The determination of the area to be operated (or 'epileptogenic zone') is based on a bundle of clinical arguments and neuroimaging, having a direct impact on surgical success. Epileptic patients have electrical abnormalities that can be detected with surface electrophysiological examinations such as surface EEG or MagnetoEncephalography (MEG). The intracerebral source of these abnormalities can be localized in the brain using source modeling techniques from MEG signals or EEG signals if a sufficient number of electrodes is used (\> 100, so-called high EEG technique Resolution = EEG HR). EEG HR and MEG are two infrequent state-of-the-art techniques. The independent contribution of EEG HR and MEG for the localization of the epileptogenic zone has been shown in several studies. However, several modeling studies have shown that MEG and EEG HR have a different detection capacity and spatial resolution depending on the cortical generators studied. Modeling studies suggest that MEG has better localization accuracy than EEG for most cortical sources. No direct comparison of the locating value of MEG and EEG HR for the localization of the epileptogenic zone has been performed to date in a large-scale clinical study. In this prospective study, 100 patients with partial epilepsy who are candidates for epilepsy surgery, and for some of them with intracranial EEG recording, will benefit from two advanced electrophysiological examinations including magnetoencephalographic recording (MEG). ) interictal electrophysiological abnormalities and high-resolution EEG recording (128 electrodes) in addition to the usual examinations performed as part of the pre-surgical assessment, prior to cortectomy and / or intracranial EEG recording. Based on recent work conducted in humans, we postulate: * that the MEG and the EEG HR make it possible to precisely determine the epileptogenic zone, by using two approaches of definition of the epileptogenic zone (zone operated in the cured patients, zone at the origin of the crises during the intracranial recordings), but that the MEG is a little more precise than the EEG HR for the determination of the epileptogenic zone (we will try to highlight a difference of about 10%) * that the quantitative study of the complementarity between EEG HR and MEG for modeling sources of epileptic spikes will show an added value in the use of both methods compared to the use of only one of the two methods * that it is possible to determine the epileptogenic zone by determining the MEG model zone having the highest centrality value (hub) within the intercritical network by studying networks using graph theory.
Eligibility Criteria
Inclusion Criteria: * patients with partial epilepsy for at least 2 years and for whom are decided and planned: either i) a surgical procedure to resect the epileptogenic zone without prior intracranial EEG recording either ii) an intracranial EEG record needed before a possible cortectomy procedure * Routine scalp EEG revealing known paroxysmal interictal abnormalities (at least 5 points on a 20-minute plot performed less than 2 years before inclusion in the study) * Patient giving written consent Exclusion Criteria: * patient aged over 60 or under 18 * patients with contraindications to brain MRI and MEG * women of childbearing age for whom a urine pregnancy test performed during the first visit would detect a pregnancy
Contact & Investigator
Julien JUNG, Dr
STUDY CHAIR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT03893916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Drug-resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03893916 currently recruiting?
Yes, NCT03893916 is actively recruiting participants. Contact the research team at julien.jung@chu-lyon.fr for enrollment information.
Where is the NCT03893916 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT03893916 clinical trial?
NCT03893916 is sponsored by Hospices Civils de Lyon. The principal investigator is Julien JUNG, Dr at Hospices Civils de Lyon. The trial plans to enroll 100 participants.
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