Skip to main content
OpenTrials
Completed

NCT Number: NCT01090934

Localizing the Epileptogenic Zone With High Resolution Electroencephalography

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Partial Epilepsy Brain Diseases Central Nervous System Diseases Disease Epilepsies, Partial Epilepsy Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Marseille, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Resolution EEG

Device

High Resolution EEG

Other names: electrical source imaging

Stereo-electroencephalography

Device

SEEG

Other names: depth-electroencephalography

Primary outcomes

  1. 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)

    Time frame: 3 years

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

Secondary outcomes

  1. inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.

    Time frame: 3 years

    sources localization of inter-ictal and ictal discharges will be interpreted by two independant epileptologists, blinded to the results of stereo-EEG.

  2. sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • CHU de Reims
  • Centre National de la Recherche Scientifique, France
  • Institut National de la Santé Et de la Recherche Médicale, France
  • University Hospital, Marseille

Registry information

Official study title

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

Acronym: EEG-HR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 23, 2010
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.