Localizing the Epileptogenic Zone With High Resolution Electroencephalography

Partial Epilepsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090934
• Other study ID #: 2009-A00574-53
• Status: Completed
• Phase: N/A
• First received: February 5, 2010
• Last updated: January 26, 2016
• Start date: October 2009
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsy

Intervention

Device:
• High Resolution EEG
High Resolution EEG
• Stereo-electroencephalography
SEEG

Locations

Country	Name	City	State
France	University Hospital of Marseille	Marseille
France	Central Hospital	Nancy

Sponsors (5)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	CHU de Reims, France: Centre National de la Recherche Scientifique, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Marseille

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. Conf Proc IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	3 years	No
Secondary	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.	3 years	No