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Localizing the Epileptogenic Zone With High Resolution Electroencephalography (EEG-HR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090934
First Posted: March 23, 2010
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Hospital, Marseille
CHU de Reims
Centre National de la Recherche Scientifique, France
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
louis maillard, Central Hospital, Nancy, France
  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: 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

Resource links provided by NLM:


Further study details as provided by louis maillard, 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 ]
    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 ]
    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 ]
    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.


Enrollment: 115
Study Start Date: October 2009
Study Completion Date: November 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090934


Locations
France
University Hospital of Marseille
Marseille, France, 13000
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
  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: 2009-A00574-53
First Submitted: February 5, 2010
First Posted: March 23, 2010
Last Update Posted: January 27, 2016
Last Verified: January 2016

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

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