Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-07 @ 10:14 AM
Study NCT ID:
NCT05901350
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2023-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D014786', 'term': 'Vision Disorders'}], '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': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-23', 'studyFirstSubmitDate': '2023-06-04', 'studyFirstSubmitQcDate': '2023-06-04', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VIPD-Q scores after STN-DBS', 'timeFrame': '12 months after STN-DBS', 'description': 'The VIPD-Q scores was recorded 12 months after STN-DBS'}], 'secondaryOutcomes': [{'measure': 'RNFL thickness', 'timeFrame': '12 months after STN-DBS'}, {'measure': 'Vessel density in ocular fundus', 'timeFrame': '12 months after STN-DBS'}, {'measure': 'Saccades with DBS on status', 'timeFrame': '1 months after STN-DBS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation', 'Levodopa'], 'conditions': ['Parkinson Disease', 'Visual Impairment']}, 'descriptionModule': {'briefSummary': 'Patients with parkinson disease (PD) usually reduced the dose the levodopa after received deep brain stimulation (DBS). However, studies seldomly mentioned about the influences on non-motors systems after the reduction. Our study focused on the changes after DBS and attribute them to the levodopa variety.', 'detailedDescription': 'We calculated that group sample sizes of 126 patients (63 in group 1; 63 in group 2) would provide 80% power to reject the null hypothesis of equal means when the mean difference is -5(10-15) with standard deviations of 10 for test group and 10 for control group at a two-sided alpha of 0.05. Given an anticipated dropout rate of 20%, total sample size required is 158 (79 in reduction; 79 in non-reduction group).\n\nWritten informed consent was obtained from all participants. After the baseline measurement, we informed the eligible patients the assigned randomization group with sealed opaque envelopes marked with the inpatient numbers .\n\nWithin 12 months after STN-DBS, the LEDD of the intervention group was consistent with that before operation, and gradually decreased under the guidance of physician according to the expert consensus of DBS after 12 months. The compliance problem was solved by determining the actual number of antiparkinsonian medications returned by participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants underwent neuro-ophthalmologic examinations, including ocular fundus photography, automated perimetry, and OCT. Patients undergoing deep brain stimulation (DBS) took an extra VIPD-Q after the operation.\n\nExclusion Criteria:\n\n* secondary causes of parkinsonism, prior brain surgery (except DBS), glaucoma, intraocular surgery, diabetes and other diseases affecting the visual field or neurologic systems, and the current use of medications affecting visual function.'}, 'identificationModule': {'nctId': 'NCT05901350', 'briefTitle': "The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation", 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': "The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation", 'orgStudyIdInfo': {'id': 'Levodopa reduction after DBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Levodopa Reduction Group After STN-DBS', 'description': 'Patients in this group started to reduce levodopa dose 1 months after STN-DBS'}, {'type': 'EXPERIMENTAL', 'label': 'Levodopa non-Reduction Group After SNT-DBS', 'description': 'Patients in this group did not reduce levodopa dose until 12 months after STN-DBS', 'interventionNames': ['Drug: Levodopa']}], 'interventions': [{'name': 'Levodopa', 'type': 'DRUG', 'description': 'Some patients did not reduced the dose of levodopa after STN-DBS comparing to some without reducing the dose.', 'armGroupLabels': ['Levodopa non-Reduction Group After SNT-DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250100', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Chao Zhang', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'chao zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}