Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Device: electroencephalogram; Device: magnetoencephalogram

• Registration Number: NCT02875964
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function.

The current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. However, non-invasive methods have been developed in order to record brain activity with no risk for the patient.

Still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. To do so, it is necessary to record simultaneously electroencephalogram (EEG) and magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain.

The objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements.

It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60 patients. It will be record resting state signals, as well as stimulation protocols. The interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. Sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. Advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-23
• Status Verified: 2019-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients for whom implanting intracerebral electrodes is underway

Exclusion Criteria

• Patients minors
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
registration of intracerebral activity	magnetoencephalogram	epileptic patient receiving implantation of intracranial electrodes
registration of intracerebral activity	electroencephalogram	epileptic patient receiving implantation of intracranial electrodes

Primary Outcome Measures

Name	Time	Method
The number of epileptic discharges	60 months	Measurement of epileptic activity by electroencephalogram

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France