Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-05 @ 9:49 AM
Study NCT ID:
NCT01945567
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2013-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D014202', 'term': 'Tremor'}, {'id': 'D020329', 'term': 'Essential Tremor'}], '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'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2013-09-14', 'studyFirstSubmitQcDate': '2013-09-14', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover trial period'}, {'measure': 'Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover trial period'}, {'measure': 'Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months', 'timeFrame': '12 months', 'description': 'At end of non-randomised empirical deep brain stimulator programming period'}, {'measure': 'Change from baseline Fahn Tolosa Marin tremor scale at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover trial period for tremor patients'}, {'measure': 'Change from baseline Fahn Tolosa Marin tremor scale at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover trial period for tremor patients'}, {'measure': 'Change from baseline Fahn Tolosa Marin tremor scale at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period for tremor patients'}], 'secondaryOutcomes': [{'measure': 'Change from baseline ON-OFF diary at 3 months', 'timeFrame': '3 months', 'description': "For Parkinson's disease"}, {'measure': 'Change from baseline ON-OFF diary at 6 months', 'timeFrame': '6 months', 'description': "For Parkinson's disease"}, {'measure': 'Change from baseline ON-OFF diary at 12 months', 'timeFrame': '12 months', 'description': "For Parkinson's disease"}, {'measure': 'Adverse events', 'timeFrame': '12 months', 'description': 'Any adverse medical event from date of randomization until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 12 months'}, {'measure': 'Change from baseline Short form 36 at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period'}, {'measure': 'Change from baseline Short form 36 at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period'}, {'measure': 'Change from baseline Short form 36 at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period'}, {'measure': 'Change from baseline Parkinsons Disease Quality of Life 39 at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline Parkinsons Disease Quality of Life 39 at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline Parkinsons Disease Quality of Life 39 at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period for Parkinsons disease'}, {'measure': 'Change from baseline L-dopa equivalent dose at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline L-dopa equivalent dose at 6 months', 'timeFrame': '3 months', 'description': 'At end of second randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline L-dopa equivalent dose at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period for Parkinsons disease'}, {'measure': 'Change from baseline neuropsychological battery at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period'}, {'measure': 'Change from baseline neuropsychological battery at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period'}, {'measure': 'Change from baseline neuropsychological battery at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period'}, {'measure': 'Change from baseline verbal fluency at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period'}, {'measure': 'Change from baseline verbal fluency at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period'}, {'measure': 'Change from baseline verbal fluency at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period'}, {'measure': 'Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period'}, {'measure': 'Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period'}, {'measure': 'Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period'}, {'measure': 'Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period for Parkinsons disease'}, {'measure': 'Change from baseline Abnormal Involuntary Movement Scale at 3 months', 'timeFrame': '3 months', 'description': 'At end of first randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline Abnormal Involuntary Movement Scale at 6 months', 'timeFrame': '6 months', 'description': 'At end of second randomised crossover period for Parkinsons disease'}, {'measure': 'Change from baseline Abnormal Involuntary Movement Scale at 12 months', 'timeFrame': '12 months', 'description': 'At end of empirical deep brain stimulator programming period for Parkinsons disease'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Essential tremor', 'Tremor', 'Deep brain stimulation', 'Posterior subthalamic area', 'Zona incerta'], 'conditions': ["Parkinson's Disease", 'Tremor']}, 'descriptionModule': {'briefSummary': "The posterior subthalamic area holds promise as a target region for deep brain stimulation in tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube surgical technique, subregions of the posterior subthalamic area can be individually targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona incerta may provide improved control of movement disorder symptoms than the more commonly stimulated dorsal zona incerta.", 'detailedDescription': 'Randomisation between two treatment locations each programmed up to 3 milliamps in amplitude for 3 months: (1) caudal zona incerta and (2) dorsal zona incerta. This 6-month-long randomised phase is followed by 6 months of unblinded individualised empirically optimised settings programmed by a neurologist. Each of the three treatment periods ends with a full clinical, functional and quality of life assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medication-refractory tremor and/or Parkinson's disease as defined by UK Brain Bank criteria with either inadequate control of motor fluctuations or dyskinesia despite optimised medical therapy\n\nExclusion Criteria:\n\n* Significant cognitive, psychiatric and medical co-morbidities\n* Dementia with mini mental state examination score of less than 25/30\n* Limited life expectancy due to a co-morbid condition"}, 'identificationModule': {'nctId': 'NCT01945567', 'briefTitle': "Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor", 'organization': {'class': 'OTHER', 'fullName': 'The University of Western Australia'}, 'officialTitle': "Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor", 'orgStudyIdInfo': {'id': '2012-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dorsal zona incerta', 'description': 'Up to 3 mA, 60 us, 130 Hz deep brain stimulation', 'interventionNames': ['Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Caudal zona incerta', 'description': 'Up to 3 mA, 60 us, 130 Hz deep brain stimulation', 'interventionNames': ['Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Empirical deep brain stimulation', 'description': 'Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.', 'interventionNames': ['Device: Empirical unblinded deep brain stimulation programming']}], 'interventions': [{'name': 'Up to 3 mA, 60 us, 130 Hz deep brain stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Caudal zona incerta', 'Dorsal zona incerta']}, {'name': 'Empirical unblinded deep brain stimulation programming', 'type': 'DEVICE', 'armGroupLabels': ['Empirical deep brain stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Christopher Lind, MBChB, FRACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Western Australia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Surgery', 'investigatorFullName': 'Professor Christopher Lind', 'investigatorAffiliation': 'The University of Western Australia'}}}}