Clinical trial NCT01090934: Localizing the Epileptogenic Zone With High Resolution Electroencephalography
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
Overall status: COMPLETED
Phase: NA
Conditions: Partial Epilepsy
Keywords: Diagnosis
Partial Epilepsy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University Hospital, Marseille
name: CHU de Reims
name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-03-23
Enrollment: 115
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: 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)
timeFrame: 3 years
Secondary outcomes:
measure: inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.
timeFrame: 3 years
measure: sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision
timeFrame: 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: University Hospital of Marseille
city: Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Louis Maillard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.