Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT02402569
Status:
TERMINATED
Last Update Posted:
2019-01-09
First Post:
2015-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2015-01-30', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, as measured by Number of Participants with Adverse Events', 'timeFrame': '3 months', 'description': 'Number of Participants with Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Neurologic evaluation', 'timeFrame': '3 months', 'description': 'Change in motor and non-motor symptoms assessment with neurologic scales'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.', 'detailedDescription': 'Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more or equal than 18 years old and less than 70 years\n* patient affiliated to social security or similarly regime\n* informed consent form signed\n* parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)\n* motor and non motor dysfunctions\n* pre-operative cerebral MRI without lesion\n* without chirurgical contraindications\n* without psychiatric disease\n\nExclusion Criteria:\n\n* Pregnant women and lactating mothers\n* Ward of court or under guardianship\n* Adult unable to express their consent\n* Person deprived of freedom by judicial or administrative decision\n* Person hospitalized without their consent\n* Person under legal protection\n* Person with carcinological antecedent during precedent 5 years\n* Chirurgical or MRI contraindications'}, 'identificationModule': {'nctId': 'NCT02402569', 'acronym': 'SIV2', 'briefTitle': 'Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)', 'orgStudyIdInfo': {'id': 'SIV2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-electrodes / single electrode', 'description': 'Multi stimulation / single stimulation', 'interventionNames': ['Device: 32 channels Deep Brain Stimulator']}, {'type': 'EXPERIMENTAL', 'label': 'Single-electrode / Multi electrodes', 'description': 'Single stimulation / Multi stimulation', 'interventionNames': ['Device: 32 channels Deep Brain Stimulator']}], 'interventions': [{'name': '32 channels Deep Brain Stimulator', 'type': 'DEVICE', 'armGroupLabels': ['Multi-electrodes / single electrode', 'Single-electrode / Multi electrodes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CLINATEC', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}