Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-13 @ 1:25 PM
Study NCT ID:
NCT03102957
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arms : epileptic patient and healthy volonteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neuronal reorganization exploration in language and memory area thanks to functionnal MRI', 'timeFrame': 'one hour for each exam', 'description': 'fMRI exam before and after resection surgery of epileptogenic area: assess (plasticity) of neuroanatomic networks associated with language and memory - examined before and after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Exploring the reorganization (plasticity) of neuroanatomic networks associated with language and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using functional MRI (fMRI)', 'detailedDescription': 'The purpose of this study is to explore the reorganization of neuroanatomic networks associated with language and memory in adult patients with temporal lobe epilepsy (ELT). By using functional MRI, patients will be examined before and after surgery. Cerebral plasticity, defined in terms of intrinsic variables such as the topography of the activated regions, will be explored according to some extrinsic factors such as the age at onset of crises (before or after 5-6 years), whether or not Hippocampal sclerosis, hemispheric predominance of language (left or right).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* epileptic patients\n* medical exam before inclusion\n* social security affiliation\n* Pharmaco-resistant epilepsy\n\nExclusion Criteria:\n\n* MRI contraindication\n* pregnant women\n* breastfeeding mothers\n* person under tutorship'}, 'identificationModule': {'nctId': 'NCT03102957', 'briefTitle': 'Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery', 'orgStudyIdInfo': {'id': '38RC09.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'epileptic patients', 'description': '2 functional MRI (pre and post resective surgery) with memory and language tasks', 'interventionNames': ['Other: functional MRI']}, {'type': 'OTHER', 'label': 'Healthy volunteers', 'description': '1 functional MRI with memory and language tasks', 'interventionNames': ['Other: functional MRI']}], 'interventions': [{'name': 'functional MRI', 'type': 'OTHER', 'armGroupLabels': ['Healthy volunteers', 'epileptic patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alexandre KRAINIK, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratoire de Psychologie et NeuroCognition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}