NCT02875964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 8, 2026

Status Verified

April 1, 2019

Enrollment Period

6.5 years

First QC Date

August 12, 2016

Last Update Submit

May 4, 2026

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • The number of epileptic discharges

    Measurement of epileptic activity by electroencephalogram

    60 months

Study Arms (1)

registration of intracerebral activity

EXPERIMENTAL

epileptic patient receiving implantation of intracranial electrodes

Device: electroencephalogramDevice: magnetoencephalogram

Interventions

magnetoencephalogramDEVICE

Implanting electrode to measure brain activity

registration of intracerebral activity
electroencephalogramDEVICE

Implanting electrode to measure brain activity

registration of intracerebral activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients for whom implanting intracerebral electrodes is underway

You may not qualify if:

  • Patients minors
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Dubarry AS, Badier JM, Trebuchon-Da Fonseca A, Gavaret M, Carron R, Bartolomei F, Liegeois-Chauvel C, Regis J, Chauvel P, Alario FX, Benar CG. Simultaneous recording of MEG, EEG and intracerebral EEG during visual stimulation: from feasibility to single-trial analysis. Neuroimage. 2014 Oct 1;99:548-58. doi: 10.1016/j.neuroimage.2014.05.055. Epub 2014 May 23.

    PMID: 24862073RESULT

MeSH Terms

Conditions

Epilepsy

Interventions

ElectroencephalographyMagnetoencephalography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 23, 2016

Study Start

October 1, 2012

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 8, 2026

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)