Localizing the Epileptogenic Zone With High Resolution Electroencephalography

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Central Hospital, Nancy, France
Sponsor:
Collaborators:
University Hospital, Marseille
CHU de Reims
France: Centre National de la Recherche Scientifique
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
louis maillard, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01090934
First received: February 5, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Partial Epilepsy
Device: High Resolution EEG
Device: Stereo-electroencephalography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG


Secondary Outcome Measures:
  • inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 125
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high resolution EEG Device: High Resolution EEG
High Resolution EEG
Other Name: electrical source imaging
Active Comparator: Stereo Electroencephalography Device: Stereo-electroencephalography
SEEG
Other Name: depth-electroencephalography

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090934

Contacts
Contact: Louis Maillard, MD, PhD +33 3 83 85 16 86 l.maillard@chu-nancy.fr
Contact: Laurent Koessler, PhD +33 3 83 85 16 86 l.koessler@chu-nancy.fr

Locations
France
University Hospital of Marseille Recruiting
Marseille, France, 13000
Contact: Martine Gavaret, MD, PhD       martine.gavaret@mail.ap-hm.fr   
Principal Investigator: Martine Gavaret, MD, PhD         
Sub-Investigator: Fabrice Bartolomei, MD, PhD         
Central Hospital Recruiting
Nancy, France, 54000
Principal Investigator: Louis Maillard, MD, PhD         
Sub-Investigator: Jean-Pierre Vignal, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
University Hospital, Marseille
CHU de Reims
France: Centre National de la Recherche Scientifique
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Louis Maillard, MD, PhD Central Hospital, Nancy, France
  More Information

Publications:
Responsible Party: louis maillard, Dr Louis MAILLARD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01090934     History of Changes
Other Study ID Numbers: PHRC 2009-17-05
Study First Received: February 5, 2010
Last Updated: July 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
Diagnosis
Partial Epilepsy

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014