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Clinical Trials/NCT01090934
NCT01090934CompletedNot Applicable

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

Central Hospital, Nancy, France4 sites in 1 country115 target enrollmentStarted: October 1, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
115
Locations
4
Primary Endpoint
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)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
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)

Outcomes

Primary Outcomes

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 Outcomes

  • inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.(3 years)
  • sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision(3 years)

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

louis maillard

Dr Louis MAILLARD

Central Hospital, Nancy, France

Study Sites (4)

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