Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01953718
Status:
COMPLETED
Last Update Posted:
2013-10-10
First Post:
2013-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of parameters (voltage, pulse width, frequency) during follow-up', 'timeFrame': 'at 12 months'}, {'measure': 'Change of UPDRS Part III score and the relation to parameters', 'timeFrame': 'at 12 months'}, {'measure': 'Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters', 'timeFrame': 'at 12 months'}], 'secondaryOutcomes': [{'measure': 'Change of daily levodopa equivalent dosage (LED) during follow-up', 'timeFrame': 'at 12 months'}]}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).", 'detailedDescription': "In this observational study, we will retrospectively analyze the one-year follow-up data of 27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University in the years 2008-2012. The data, including parameter settings and severity of motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, was collected during the patients' annual visit to the hospital for reprogramming. A correlation analysis will be conducted to investigate the relationship between change of a specific parameter and the subsequent change of motor scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012\n\nExclusion Criteria:\n\n* Simultaneous participation in another clinical trial\n* Dementia (Mini Mental State Examination \\< 26)\n* Removal of DBS electrodes\n* Loss to follow-up'}, 'identificationModule': {'nctId': 'NCT01953718', 'briefTitle': 'A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation', 'orgStudyIdInfo': {'id': '[2008]20'}, 'secondaryIdInfos': [{'id': '10151008901000187', 'type': 'OTHER_GRANT', 'domain': 'GNSF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Chen Ling', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}