Localizing the Epileptogenic Zone With High Resolution Electroencephalography

Not Applicable

Completed

• Conditions: Partial Epilepsy
• Interventions: Device: High Resolution EEG; Device: Stereo-electroencephalography

• Registration Number: NCT01090934
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-23
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
• Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
• full informed consent of the patient (or of his/ her legal representative)
• 15 year or older patient

Exclusion Criteria

• contraindication to cortectomy

• contraindication to depth-EEG

• indication of epilepsy surgery without depth-EEG monitoring

• high grade glioma, arterio-veinous malformations

  • pregnancy
  • history of severe cardio-vascular event (coronaropathy, stroke)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
high resolution EEG	High Resolution EEG	-
Stereo Electroencephalography	Stereo-electroencephalography	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method)	3 years	results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG

Secondary Outcome Measures

Name	Time	Method
inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.	3 years	sources localization of inter-ictal and ictal discharges will be interpreted by two independant epileptologists, blinded to the results of stereo-EEG.
sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision	3 years	decision of surgery and the limits of the cortectomy established with electrical source imaging will be compared to the decision of surgery and the limits of the cortectomy established with Stereo-electroencephalography.

Trial Locations

Locations (2)

Central Hospital; 🇫🇷 Nancy, France

University Hospital of Marseille; 🇫🇷 Marseille, France