Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT03409120
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2018-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'C567844', 'term': 'Dystonia-Parkinsonism, Adult-Onset'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D004421', 'term': 'Dystonia'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clg17@uab.edu', 'phone': '2059753732', 'title': 'Christopher Gonzalez', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Time and physical constraints during surgery sometimes limit data collection, and acute implant of the DBS lead introduces microlesion effects that could alter electrophysiology.'}}, 'adverseEventsModule': {'timeFrame': '1 year from baseline visit', 'eventGroups': [{'id': 'EG000', 'title': 'Dystonia Severity Assessment', 'description': 'We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline.\n\nBoston Scientific Vercise PC IPG with directional DBS lead: We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Burke-Fahn-Marsden Dystonia Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Patients Enrolled in Study', 'description': 'All patients enrolled in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '6.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed data from all enrolled participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dystonia Severity Assessment', 'description': 'We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline.\n\nBoston Scientific Vercise PC IPG with directional DBS lead: We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited and studied prospectively as part of the SUNDIAL (SUbthalamic Nucleus DIrectionAL stimulation) study, a randomized, double-blind crossover study contrasting directional versus circular unilateral STN DBS for PD (FDA Investigational Device Exemption G-170063). Further details on inclusion/exclusion are outlined at https://clinicaltrials.gov/ct2/show/NCT03353688.', 'preAssignmentDetails': 'All subjects provided written informed consent prior to participation with approval from the institutional review board. We included data from all consecutively enrolled participants. Dystonia status was not part of the enrollment criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Patients Enrolled in Study', 'description': 'All patients enrolled in the study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', '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': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Burke-Fahn-Marsden Total Dystonia Scale', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-12-11', 'size': 814716, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-09T15:49', 'hasProtocol': True}, {'date': '2019-11-13', 'size': 96232, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-09T15:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study will run in conjunction with "Biomarkers to Guide Directional DBS for Parkinson\'s Disease" (ClinicalTrials.gov Identifier: NCT03353688). It is a double blinded study investigating the effectiveness of directional DBS leads in which participants and some investigators will have no knowledge of the DBS settings participants experience.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To measure the effects of directional DBS on dystonia, we will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2018-01-13', 'resultsFirstSubmitDate': '2022-06-24', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-17', 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burke-Fahn-Marsden Dystonia Rating Scale', 'timeFrame': '5 minutes', 'description': 'Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dystonia', "Parkinson's Disease"], 'conditions': ['Dystonia-Parkinsonism, Adult-Onset', 'Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '35702056', 'type': 'BACKGROUND', 'citation': "Olson JW, Nakhmani A, Irwin ZT, Edwards LJ, Gonzalez CL, Wade MH, Black SD, Awad MZ, Kuhman DJ, Hurt CP, Guthrie BL, Walker HC. Cortical and Subthalamic Nucleus Spectral Changes During Limb Movements in Parkinson's Disease Patients with and Without Dystonia. Mov Disord. 2022 Aug;37(8):1683-1692. doi: 10.1002/mds.29057. Epub 2022 Jun 14."}]}, 'descriptionModule': {'briefSummary': 'This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson\'s Disease" (ClinicalTrials.gov Identifier: NCT03353688). If participants have dystonia associated with Parkinson\'s disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.', 'detailedDescription': 'To measure the effects of DBS on dystonia, the investigators will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline. This will allow them to contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrollment in "Biomarkers to Guide Directional DBS for Parkinson\'s Disease" (ClinicalTrials.gov Identifier: NCT03353688)\n* Diagnosis of Parkinson\'s disease with and without dystonia\n\nExclusion Criteria:\n\n* Not enrolled in "Biomarkers to Guide Directional DBS for Parkinson\'s Disease" (ClinicalTrials.gov Identifier: NCT03353688)'}, 'identificationModule': {'nctId': 'NCT03409120', 'briefTitle': "Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology", 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': "Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology", 'orgStudyIdInfo': {'id': 'IRB-300001136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dystonia Severity Assessment', 'description': 'We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline.', 'interventionNames': ['Device: Boston Scientific Vercise PC IPG with directional DBS lead']}], 'interventions': [{'name': 'Boston Scientific Vercise PC IPG with directional DBS lead', 'type': 'DEVICE', 'description': 'We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.', 'armGroupLabels': ['Dystonia Severity Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Harrison C Walker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology', 'investigatorFullName': 'Harrison Walker, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}