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Localizing the Epileptogenic Zone With High Resolution Electroencephalography

Etude de la Performance Diagnostique de l'EEG-Haute Résolution Sur la Localisation de la Zone épileptogène Pour le Traitement Chirurgical Des épilepsies Partielles Pharmaco-résistantes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01090934
Acronym
EEG-HR
Enrollment
115
Registered
2010-03-23
Start date
2009-10-31
Completion date
2013-11-30
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Epilepsy

Keywords

Diagnosis, Partial Epilepsy

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.

Interventions

High Resolution EEG

DEVICEStereo-electroencephalography

SEEG

Sponsors

University Hospital, Marseille
CollaboratorOTHER
CHU de Reims
CollaboratorOTHER
Centre National de la Recherche Scientifique, France
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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 yearsresults of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG

Secondary

MeasureTime frameDescription
inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.3 yearssources 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 decision3 yearsdecision 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026