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

NCT ID: NCT02875964

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2019-04-30

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

registration of intracerebral activity

epileptic patient receiving implantation of intracranial electrodes

Group Type: EXPERIMENTAL

electroencephalogram

Intervention Type: DEVICE

Implanting electrode to measure brain activity

magnetoencephalogram

Intervention Type: DEVICE

Implanting electrode to measure brain activity

Interventions

electroencephalogram

Implanting electrode to measure brain activity

Intervention Type: DEVICE

magnetoencephalogram

Implanting electrode to measure brain activity

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients for whom implanting intracerebral electrodes is underway

Exclusion Criteria

• Patients minors
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2012-A00644-39

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-16

Identifier Type: -

Identifier Source: org_study_id