EEG-HR: Localizing the Epileptogenic Zone With High Resolution Electroencephalography

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT01090934
Collaborator
University Hospital, Marseille (Other), CHU de Reims (Other), Centre National de la Recherche Scientifique, France (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other)
115
2
2
49
57.5
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High Resolution EEG
  • Device: Stereo-electroencephalography
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: high resolution EEG

Device: High Resolution EEG
High Resolution EEG
Other Names:
  • electrical source imaging
  • Active Comparator: Stereo Electroencephalography

    Device: Stereo-electroencephalography
    SEEG
    Other Names:
  • depth-electroencephalography
  • Outcome Measures

    Primary Outcome Measures

    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) [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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Marseille Marseille France 13000
    2 Central Hospital Nancy France 54000

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Louis Maillard, MD, PhD, Central Hospital, Nancy, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    louis maillard, Dr Louis MAILLARD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT01090934
    Other Study ID Numbers:
    • 2009-A00574-53
    First Posted:
    Mar 23, 2010
    Last Update Posted:
    Jan 27, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by louis maillard, Dr Louis MAILLARD, Central Hospital, Nancy, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2016