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

January 26, 2016 updated by: louis maillard, Central Hospital, Nancy, France

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13000
        • University Hospital of Marseille
      • Nancy, France, 54000
        • Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

March 19, 2010

First Posted (ESTIMATE)

March 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A00574-53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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