Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT03543267
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2018-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.', 'timeFrame': 'One hour and thirty minutes', 'description': 'The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.\n\nFor that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of pharmaco-resistant focal epilepsy\n* Patient candidate for surgery to resect the epileptogenic zone\n* Patients affiliated to a social security scheme or beneficiaries of such a scheme\n* Patients with French as their mother tongue\n* Patients who have given signed informed consent before performing any procedure related to the study.\n\nExclusion Criteria:\n\n* Contraindication to performing an MRI:\n* Intellectual disability objectified by a Mini Mental Score (MMS) score \\<24 in the year preceding inclusion,\n* Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous,\n* Participation in other research protocols underway with exclusion period or in the previous week,\n* Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.'}, 'identificationModule': {'nctId': 'NCT03543267', 'acronym': 'FaisPLASTICITE', 'briefTitle': 'Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging', 'orgStudyIdInfo': {'id': '38RC17.018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'epileptic Patients', 'interventionNames': ['Other: MRI exam']}], 'interventions': [{'name': 'MRI exam', 'type': 'OTHER', 'description': 'MRI before and after resection surgery', 'armGroupLabels': ['epileptic Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble-Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Monica BACIU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre National de la Recherche Scientifique, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratoire de Psychologie et NeuroCognition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}