Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-04 @ 2:33 AM
Study NCT ID:
NCT03227250
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2017-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Bilateral GPI DBS on Freezing of Gait in PD
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-04', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of the scores in MDS-UPDRS', 'timeFrame': 'baseline, 12 month'}], 'primaryOutcomes': [{'measure': 'Changs in the score of Timed Up and Go Test', 'timeFrame': 'baseline, 12 month'}], 'secondaryOutcomes': [{'measure': 'Change of the score in GFQ', 'timeFrame': 'baseline, 12 month'}, {'measure': 'Change of the score in FoG total time of TUG test', 'timeFrame': 'baseline, 12 month'}, {'measure': 'Change of the score in FoG Episodes of TUG test', 'timeFrame': 'baseline, 12 month'}, {'measure': 'Change of the score in Proportion of FoG of TUG test', 'timeFrame': 'baseline, 12 month'}, {'measure': 'Change of the score in Longest FoG duration of TUG test', 'timeFrame': 'baseline, 12 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['freezing of gait', 'Parkinson disease', 'GPi'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Parkinson's Disease who underwent GPI DBS.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria: (1) idiopathic PD, according to the MDS Parkinson's Disease Society Diagnostic Criteria17; (2) bilateral GPi-DBS implant according to a careful consideration of patients' symptom profiles (e.g., existence and severity of dyskinesia, dystonia, axial symptoms, or cognitive and mood problems); (3) onset of PD at or before 70 years of age; and (4) disease duration of more than 3 years at the time of surgery.\n\nPatients were excluded if they had unstable vital signs or medical and psychiatric comorbidities at the time of the study."}, 'identificationModule': {'nctId': 'NCT03227250', 'acronym': 'PD GPI DBS', 'briefTitle': 'Effects of Bilateral GPI DBS on Freezing of Gait in PD', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': "Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases", 'orgStudyIdInfo': {'id': 'GPIFOG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GPI DBS', 'description': 'patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Haiyan Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine'}, {'name': 'Shengdi Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine'}, {'name': 'Dianyou Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine'}, {'name': 'Bomin Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine'}, {'name': 'Wei Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haiyan Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'attending neurologist', 'investigatorFullName': 'Haiyan Zhou', 'investigatorAffiliation': 'Ruijin Hospital'}}}}