NCT01090934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

February 5, 2010

Last Update Submit

January 26, 2016

Conditions

Partial Epilepsy

Keywords

DiagnosisPartial Epilepsy

Outcome Measures

Primary Outcomes (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)

    results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG

    3 years

Secondary Outcomes (2)

  • 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

Study Arms (2)

high resolution EEG

EXPERIMENTAL
Device: High Resolution EEG

Stereo Electroencephalography

ACTIVE COMPARATOR
Device: Stereo-electroencephalography

Interventions

High Resolution EEGDEVICE

High Resolution EEG

Also known as: electrical source imaging
high resolution EEG
Stereo-electroencephalographyDEVICE

SEEG

Also known as: depth-electroencephalography
Stereo Electroencephalography

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • year or older patient

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Marseille

Marseille, 13000, France

Location

Central Hospital

Nancy, 54000, France

Location

Related Publications (4)

  • 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.

    PMID: 19632148BACKGROUND

  • 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.

    PMID: 20206700BACKGROUND

  • 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.

    PMID: 21140291RESULT

  • 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.

    PMID: 21095980RESULT

MeSH Terms

Conditions

Epilepsies, PartialDisease

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Louis Maillard, MD, PhD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Louis MAILLARD

Study Record Dates

First Submitted

February 5, 2010

First Posted

March 23, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

FR(2)