Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02071134
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2014-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline", 'timeFrame': 'up to 3 years', 'description': "Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline"}, {'measure': 'Change in medication usage during the study as compared with baseline', 'timeFrame': 'up to 3 years'}, {'measure': 'Impression of change scores during the study as compared with baseline', 'timeFrame': '3 years', 'description': 'Impression of change scores during the study as compared with baseline'}], 'primaryOutcomes': [{'measure': "Improvement in patient's quality of life (QoL) during the study as compared with baseline", 'timeFrame': 'up to 3 years', 'description': 'Change in quality of life assessments during the study as compared with baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Deep brain stimulation', "Parkinson's disease", 'Vercise'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.\n\nThe utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.\n\nAdditionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.", 'detailedDescription': "The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.\n\nSubjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with symptoms of Parkinson's disease that are not adequately controlled with medication", 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Meets criteria established in locally applicable Vercise System Direction for Use\n* At least 18 years old\n\nKey Exclusion Criteria:\n\n* Meets any contraindication in the Vercise System locally applicable Directions for Use\n\nSubjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.'}, 'identificationModule': {'nctId': 'NCT02071134', 'briefTitle': 'Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry', 'orgStudyIdInfo': {'id': 'A4010'}, 'secondaryIdInfos': [{'id': 'A4069', 'type': 'OTHER', 'domain': 'Boston Scientific Corporation U.S. Study'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease", 'description': "Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.", 'interventionNames': ['Device: Deep Brain Stimulation (DBS)']}], 'interventions': [{'name': 'Deep Brain Stimulation (DBS)', 'type': 'DEVICE', 'otherNames': ['Vercise DBS System', 'Boston Scientific'], 'description': "Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.", 'armGroupLabels': ["Parkinson's disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '92656', 'city': 'Aliso Viejo', 'state': 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'Boston Scientific Clinical Research', 'role': 'CONTACT', 'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890'}], 'facility': "St. Mary's Hospital and Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boston Scientific Clinical Research Manager', 'role': 'CONTACT', 'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890'}], 'facility': 'University of Florida Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Mayo Clinic, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boston Scientific Clinical Research Manager', 'role': 'CONTACT', 'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890'}], 'facility': 'University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Tallahassee Neurological Clinic, PA', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boston Scientific Clinical Research Manager', 'role': 'CONTACT', 'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boston Scientific Clinical Research Manager', 'role': 'CONTACT', 'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890'}], 'facility': 'St. 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