Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-30 @ 2:18 PM
Study NCT ID:
NCT01090934
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2010-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Localizing the Epileptogenic Zone With High Resolution Electroencephalography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2010-02-05', 'studyFirstSubmitQcDate': '2010-03-19', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG'}], 'secondaryOutcomes': [{'measure': 'inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.', 'timeFrame': '3 years', 'description': 'sources localization of inter-ictal and ictal discharges will be interpreted by two independant epileptologists, blinded to the results of stereo-EEG.'}, {'measure': 'sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision', 'timeFrame': '3 years', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diagnosis', 'Partial Epilepsy'], 'conditions': ['Partial Epilepsy']}, 'referencesModule': {'references': [{'pmid': '19632148', 'type': 'BACKGROUND', '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.'}, {'pmid': '20206700', 'type': 'BACKGROUND', '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.'}, {'pmid': '21140291', 'type': 'RESULT', '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.'}, {'pmid': '21095980', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.\n* Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.\n* full informed consent of the patient (or of his/ her legal representative)\n* 15 year or older patient\n\nExclusion Criteria:\n\n* contraindication to cortectomy\n* contraindication to depth-EEG\n* indication of epilepsy surgery without depth-EEG monitoring\n* high grade glioma, arterio-veinous malformations\n\n * pregnancy\n * history of severe cardio-vascular event (coronaropathy, stroke)'}, 'identificationModule': {'nctId': 'NCT01090934', 'acronym': 'EEG-HR', 'briefTitle': 'Localizing the Epileptogenic Zone With High Resolution Electroencephalography', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '2009-A00574-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high resolution EEG', 'interventionNames': ['Device: High Resolution EEG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stereo Electroencephalography', 'interventionNames': ['Device: Stereo-electroencephalography']}], 'interventions': [{'name': 'High Resolution EEG', 'type': 'DEVICE', 'otherNames': ['electrical source imaging'], 'description': 'High Resolution EEG', 'armGroupLabels': ['high resolution EEG']}, {'name': 'Stereo-electroencephalography', 'type': 'DEVICE', 'otherNames': ['depth-electroencephalography'], 'description': 'SEEG', 'armGroupLabels': ['Stereo Electroencephalography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'University Hospital of Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Central Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Louis Maillard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Marseille', 'class': 'OTHER'}, {'name': 'CHU de Reims', 'class': 'OTHER'}, {'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Louis MAILLARD', 'investigatorFullName': 'louis maillard', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}