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

Primary Purpose

Partial Epilepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Resolution EEG
Stereo-electroencephalography
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Partial Epilepsy focused on measuring Diagnosis, Partial Epilepsy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital of Marseille
  • Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high resolution EEG

Stereo Electroencephalography

Arm Description

Outcomes

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)
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.
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
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.

Full Information

First Posted
February 5, 2010
Last Updated
January 26, 2016
Sponsor
Central Hospital, Nancy, France
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
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1. Study Identification

Unique Protocol Identification Number
NCT01090934
Brief Title
Localizing the Epileptogenic Zone With High Resolution Electroencephalography
Acronym
EEG-HR
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
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

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
Diagnosis, Partial Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high resolution EEG
Arm Type
Experimental
Arm Title
Stereo Electroencephalography
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High Resolution EEG
Other Intervention Name(s)
electrical source imaging
Intervention Description
High Resolution EEG
Intervention Type
Device
Intervention Name(s)
Stereo-electroencephalography
Other Intervention Name(s)
depth-electroencephalography
Intervention Description
SEEG
Primary Outcome Measure Information:
Title
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)
Description
results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG
Time Frame
3 years
Secondary Outcome Measure Information:
Title
inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.
Description
sources localization of inter-ictal and ictal discharges will be interpreted by two independant epileptologists, blinded to the results of stereo-EEG.
Time Frame
3 years
Title
sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Maillard, MD, PhD
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Marseille
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Central Hospital
City
Nancy
ZIP/Postal Code
54000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19632148
Citation
Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24.
Results Reference
background
PubMed Identifier
20206700
Citation
Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4.
Results Reference
background
PubMed Identifier
21140291
Citation
Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8.
Results Reference
result
PubMed Identifier
21095980
Citation
Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321.
Results Reference
result

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Localizing the Epileptogenic Zone With High Resolution Electroencephalography

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