Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-04-17 @ 11:59 PM
Study NCT ID:
NCT02022735
Status:
TERMINATED
Last Update Posted:
2021-05-28
First Post:
2013-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cluca@med.miami.edu', 'phone': '305-243-6732', 'title': 'Corneliu Luca, MD, PhD', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Bilateral Stimulation', 'description': 'Participants will receive Deep Brain Stimulation Bilaterally.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Left Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the left side only', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Right Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the right side only', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'OFF Stimulation', 'description': 'Participants will receive no Deep Brain Stimulation', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Walking Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Stimulation', 'description': 'Participants will receive Deep Brain Stimulation Bilaterally.'}, {'id': 'OG001', 'title': 'Left Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the left side only'}, {'id': 'OG002', 'title': 'Right Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the right side only'}, {'id': 'OG003', 'title': 'OFF Stimulation', 'description': 'Participants will receive no Deep Brain Stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '0.84', 'spread': '0.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 hour', 'description': 'Walking speed will be measured using sensors reported in meter per second.', 'unitOfMeasure': 'meter per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completed all 4 arms in the cross over study design.'}, {'type': 'SECONDARY', 'title': 'Stride Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Stimulation', 'description': 'Participants will receive Deep Brain Stimulation Bilaterally.'}, {'id': 'OG001', 'title': 'Left Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the left side only'}, {'id': 'OG002', 'title': 'Right Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the right side only'}, {'id': 'OG003', 'title': 'OFF Stimulation', 'description': 'Participants will receive no Deep Brain Stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '1.06', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.95', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 hour', 'description': 'Stride length will be measured using sensors and will be reported in meters.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants completed all 4 arms in the crossover study design.'}, {'type': 'SECONDARY', 'title': 'UPDRS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Stimulation', 'description': 'Participants will receive Deep Brain Stimulation Bilaterally.'}, {'id': 'OG001', 'title': 'Left Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the left side only'}, {'id': 'OG002', 'title': 'Right Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the right side only'}, {'id': 'OG003', 'title': 'OFF Stimulation', 'description': 'Participants will receive no Deep Brain Stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '24.09', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '38.36', 'spread': '3.52', 'groupId': 'OG001'}, {'value': '35.59', 'spread': '3.19', 'groupId': 'OG002'}, {'value': '48.68', 'spread': '3.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 hour', 'description': "Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completed all 4 arms in the crossover study design'}, {'type': 'SECONDARY', 'title': 'TUG Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Stimulation', 'description': 'Participants will receive Deep Brain Stimulation Bilaterally.'}, {'id': 'OG001', 'title': 'Left Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the left side only'}, {'id': 'OG002', 'title': 'Right Stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the right side only'}, {'id': 'OG003', 'title': 'OFF Stimulation', 'description': 'Participants will receive no Deep Brain Stimulation'}], 'timeFrame': 'Up to 1 hour', 'description': 'Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair.', 'reportingStatus': 'POSTED', 'populationDescription': 'Team member with access to TUG score data analysis has left the institution. PI was not given access to retrieve data prior to study team member leaving the institution.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All participants enrolled in the study completed the 4 arms crossover study design. All participants received and was evaluated for all four interventions: Bilateral Deep Brain Stimulation (DBS), Right Side DBS, Left side DBS and Off/No Stimulation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants that completed the 4 arm crossover study design'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-04', 'size': 253576, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-03T13:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Funding not secured', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2013-12-05', 'resultsFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2013-12-27', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-08', 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking Speed', 'timeFrame': 'Up to 1 hour', 'description': 'Walking speed will be measured using sensors reported in meter per second.'}], 'secondaryOutcomes': [{'measure': 'Stride Length', 'timeFrame': 'Up to 1 hour', 'description': 'Stride length will be measured using sensors and will be reported in meters.'}, {'measure': 'UPDRS Scores', 'timeFrame': 'Up to 1 hour', 'description': "Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition."}, {'measure': 'TUG Test', 'timeFrame': 'Up to 1 hour', 'description': 'Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.\n* On stable dose of dopaminergic drugs\n* Age 45-70 years of age\n\nExclusion Criteria:\n\n* Past medical history of seizures\n* Renal insufficiency\n* Cardiac arrhythmia\n* Severe arthritis\n* Women of childbearing potential\n* Dementia\n* Less than 45 years of age or older than 70 years of age"}, 'identificationModule': {'nctId': 'NCT02022735', 'briefTitle': "Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': "Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '20130225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilateral stimulation', 'description': 'Participants will receive Deep Brain Stimulation Bilaterally.', 'interventionNames': ['Device: Deep Brain Stimulator']}, {'type': 'EXPERIMENTAL', 'label': 'Left stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the left side only', 'interventionNames': ['Device: Deep Brain Stimulator']}, {'type': 'EXPERIMENTAL', 'label': 'Right stimulation', 'description': 'Participants will receive Deep Brain Stimulation on the right side only', 'interventionNames': ['Device: Deep Brain Stimulator']}, {'type': 'NO_INTERVENTION', 'label': 'Off stimulation', 'description': 'Participants will receive no brain stimulation'}], 'interventions': [{'name': 'Deep Brain Stimulator', 'type': 'DEVICE', 'otherNames': ['DBS'], 'description': 'DBS will provide brain stimulation.', 'armGroupLabels': ['Bilateral stimulation', 'Left stimulation', 'Right stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Corneliu Luca, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology', 'investigatorFullName': 'Corneliu C Luca', 'investigatorAffiliation': 'University of Miami'}}}}