Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-01-01 @ 2:01 PM
Study NCT ID:
NCT02245061
Status:
UNKNOWN
Last Update Posted:
2019-10-23
First Post:
2014-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Excitability Assessment Using Paired Pulses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex', 'timeFrame': 'between Day 7 and 21 (End of the stereoelectroencephalographic recordings)', 'description': 'Low frequency single pulse electrical stimulation induces several cortico-cortical electroencephalographic responses: early-physiological and/or late-pathological. We expect different paired pulses modulation of those responses according the excitability level of the stimulated cortex (in terms of latency, amplitude, surface, frequency power)'}], 'secondaryOutcomes': [{'measure': 'Presence of a difference of responses patterns between anatomic regions and/or lesion type', 'timeFrame': 'between Day 7 and 21 (End of the stereoelectroencephalographic recordings )'}, {'measure': 'Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations', 'timeFrame': 'Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacoresistant focal epilepsy', 'cortical excitability', 'paired pulses', 'TMS', 'SEEG', 'DES'], 'conditions': ['Focal Epilepsy']}, 'descriptionModule': {'briefSummary': 'The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.\n\nHowever, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.\n\nThe cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years old\n* Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic recording\n* Provide written consent to the study after receiving clear information\n* Be a beneficiary or member of health insurance plan\n\nExclusion Criteria:\n\nPatient with contraindication for MRI scanning\n\n* Pregnancy\n* Prohibition on participation in other research, apart from any other non-interventional research'}, 'identificationModule': {'nctId': 'NCT02245061', 'acronym': 'PP', 'briefTitle': 'Cortical Excitability Assessment Using Paired Pulses', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography', 'orgStudyIdInfo': {'id': '2014.865'}, 'secondaryIdInfos': [{'id': '2014-A00495-42', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'paired pulses cortical electrical stimulation', 'interventionNames': ['Other: paired pulses cortical electrical stimulation']}], 'interventions': [{'name': 'paired pulses cortical electrical stimulation', 'type': 'OTHER', 'armGroupLabels': ['paired pulses cortical electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain RHEIMS, MD', 'role': 'CONTACT', 'email': 'sylvain.rheims@chu-lyon.fr', 'phone': '4 17 30 60 64', 'phoneExt': '+33'}], 'facility': 'Hôpital neurologique de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Sylvain RHEIMS, MD', 'role': 'CONTACT', 'email': 'sylvain.rheims@univ-lyon1.fr', 'phone': '4 17 30 60 64', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}