Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT04390867
Status:
TERMINATED
Last Update Posted:
2022-06-27
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-07', 'mcpReleaseN': 9, 'releaseDate': '2023-02-08'}], 'estimatedResultsFirstSubmitDate': '2023-02-08'}}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and Outcomes Assessor blinded to DBS pattern in use'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Random order of presentation of all three TOPS and Standard DBS in each participant'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Business decision on June 2, 2022', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS", 'timeFrame': 'After 1 week treatment period using each pattern', 'description': "Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms."}, {'measure': 'Study related adverse device effects', 'timeFrame': 'After 1 week treatment period using TOPS1', 'description': 'Reported AEs'}, {'measure': 'Study related adverse device effects', 'timeFrame': 'After 1 week treatment period using TOPS2', 'description': 'Reported AEs'}, {'measure': 'Study related adverse device effects', 'timeFrame': 'After 1 week treatment period using TOPS3', 'description': 'Reported AEs'}, {'measure': 'Study related adverse device effects', 'timeFrame': 'After 1 week treatment period using Standard', 'description': 'Reported AEs'}], 'secondaryOutcomes': [{'measure': 'Home Use "On Time"', 'timeFrame': 'During 1 week treatment period using each pattern', 'description': 'Home use Parkinson\'s disease motor symptom diary recording On Time without dyskinesia, On Time with non-troublesome dyskinesia, On Time with troublesome dyskinesia, Off Time, and Asleep Time. Average "On Time" difference between the best TOPS and Standard'}, {'measure': 'Patient Global Impression of Improvement Rating', 'timeFrame': 'After 1 week treatment period using each pattern', 'description': 'Average difference in PGII between the best TOPS and Standard. Improvement is scored on a scale of 1 - 7 where 1 is Very Much Improved and 7 is Very Much Worse'}, {'measure': "Parkinson's Medication Use", 'timeFrame': 'During 1 week treatment period using each pattern', 'description': "Parkinson's medication usage recorded in home use medication diary. Average difference between the best TOPS and Standard"}, {'measure': 'Rest Tremor - Off medication/On DBS', 'timeFrame': 'After 1 week treatment period using each pattern', 'description': 'Measured using Kinesia One system. Average difference between the best TOPS and Standard'}, {'measure': 'Postural Tremor - Off medication/On DBS', 'timeFrame': 'After 1 week treatment period using each pattern', 'description': 'Measured using Kinesia One system. Average difference between the best TOPS and Standard.'}, {'measure': 'Bradykinesia - Off medication/On DBS', 'timeFrame': 'After 1 week treatment period using each pattern', 'description': 'Measured using Kinesia One system. Average difference between the best TOPS and Standard.'}, {'measure': 'Type and severity of side effects of stimulation', 'timeFrame': 'During 1 week treatment period using each pattern', 'description': 'Proportion of participants experiencing side effects recorded in home use motor symptom diary and clinic. Average difference between the best TOPS and Standard'}, {'measure': "Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS", 'timeFrame': 'After 1 week treatment period using each pattern', 'description': "Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms."}, {'measure': 'Clinical Global Impression of Improvement Rating', 'timeFrame': 'After 1 week treatment period using each pattern', 'description': 'Average difference in CGII score between the best TOPS and Standard. Improvement is scored on a scale of 1 - 7 where 1 is Very Much Improved and 7 is Very Much Worse'}, {'measure': 'Test Pattern Use Count', 'timeFrame': 'After 1 week treatment period using each pattern', 'description': 'For each pattern, the number of subjects who go home with it and use it for the entire test period (\\~7-14 days) will be counted to evaluate if any patterns are more or less likely to be skipped'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Diagnosed with Parkinson's disease\n* Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date\n* Responds to DBS by having demonstrated a minimum improvement in motor score\n\nKey Exclusion Criteria:\n\n* Score of \\<24 on the Mini Mental Status Exam\n* Abuses drugs or alcohol\n* Pregnant\n* History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)\n* Prisoners, employees that report to investigators"}, 'identificationModule': {'nctId': 'NCT04390867', 'acronym': 'TOPS', 'briefTitle': "Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Deep Brain Innovations LLC'}, 'officialTitle': "A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease", 'orgStudyIdInfo': {'id': '0152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOPS1 DBS', 'description': 'Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order.', 'interventionNames': ['Device: TOPS1 DBS', 'Device: TOPS2 DBS', 'Device: TOPS3 DBS', 'Device: Standard DBS']}, {'type': 'EXPERIMENTAL', 'label': 'TOPS2 DBS', 'description': 'Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order.', 'interventionNames': ['Device: TOPS1 DBS', 'Device: TOPS2 DBS', 'Device: TOPS3 DBS', 'Device: Standard DBS']}, {'type': 'EXPERIMENTAL', 'label': 'TOPS3 DBS', 'description': 'Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order.', 'interventionNames': ['Device: TOPS1 DBS', 'Device: TOPS2 DBS', 'Device: TOPS3 DBS', 'Device: Standard DBS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard DBS', 'description': 'Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.', 'interventionNames': ['Device: TOPS1 DBS', 'Device: TOPS2 DBS', 'Device: TOPS3 DBS', 'Device: Standard DBS']}], 'interventions': [{'name': 'TOPS1 DBS', 'type': 'DEVICE', 'description': 'TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system', 'armGroupLabels': ['Standard DBS', 'TOPS1 DBS', 'TOPS2 DBS', 'TOPS3 DBS']}, {'name': 'TOPS2 DBS', 'type': 'DEVICE', 'description': 'TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system', 'armGroupLabels': ['Standard DBS', 'TOPS1 DBS', 'TOPS2 DBS', 'TOPS3 DBS']}, {'name': 'TOPS3 DBS', 'type': 'DEVICE', 'description': 'TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system', 'armGroupLabels': ['Standard DBS', 'TOPS1 DBS', 'TOPS2 DBS', 'TOPS3 DBS']}, {'name': 'Standard DBS', 'type': 'DEVICE', 'description': 'Standard is the pattern of stimulation that is usually delivered clinically by a DBS system', 'armGroupLabels': ['Standard DBS', 'TOPS1 DBS', 'TOPS2 DBS', 'TOPS3 DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deep Brain Innovations LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}