Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02963259
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2016-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IPG Replacement Study (PREFERENCE-H)
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': 'Erika.ross@abbott.com', 'phone': '+19725268207', 'title': 'Erika Ross', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system\n\nSJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'High Impedance in Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Worsening of Motor/Parkinson's Disease Symptoms - Akinesia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system\n\nSJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Months', 'description': 'Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Number of Events Per Patient-year of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system\n\nSJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after IPG replacement', 'description': 'Total number of safety events related to battery replacement surgical procedures for hybrid systems divided by total follow-up duration from IPG replacement visit to either 12M visit or withdrawal visit (patient-years).', 'unitOfMeasure': 'events per patient-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Incidence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system\n\nSJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after IPG replacement', 'description': 'Number of subjects who underwent IPG replacement and encountered safety events related to battery replacement surgical procedure for hybrid system divided by total subjects who underwent IPG replacement.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system\n\nSJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'IPG Replacement not Done with Abbott Device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Subject Participation Terminated by Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject Did Not Meet Inclusion/Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study enrolled a total of 17 subjects in 5 centers across Europe and United States between 29 March 2017 and 3 December 2018. Of the 17 enrolled subjects, 16 subjects were evaluated at the baseline visit and 12 completed the 3- and 12-month visit.', 'preAssignmentDetails': 'Of the total 17 participants enrolled, 5 were withdrawn for the reasons listed and only 16 completed the baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG System', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system\n\nSJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system: Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.4', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'UPDRS Score', 'classes': [{'title': 'UPDRS III on stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '16.1', 'groupId': 'BG000'}]}]}, {'title': 'UPDRS III off stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.8', 'spread': '18.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The UPDRS score collected at baseline is relevant because it presents patient's baseline motor severity.\n\nThe modified UPDRS retains the four-scale structure with a reorganization of the various subscales. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-10', 'size': 582159, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-27T23:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2016-11-10', 'resultsFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-22', 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.', 'timeFrame': '3 Months', 'description': 'Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Number of Events Per Patient-year of Follow-up', 'timeFrame': '12 months after IPG replacement', 'description': 'Total number of safety events related to battery replacement surgical procedures for hybrid systems divided by total follow-up duration from IPG replacement visit to either 12M visit or withdrawal visit (patient-years).'}, {'measure': 'Incidence Rate', 'timeFrame': '12 months after IPG replacement', 'description': 'Number of subjects who underwent IPG replacement and encountered safety events related to battery replacement surgical procedure for hybrid system divided by total subjects who underwent IPG replacement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SJM Infinity™', 'SJM Brio™', 'Implantable pulse generator (IPG) replacement', 'SJM-CIP-10135', 'Deep brain stimulation (DBS)'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have a diagnosis matching the approved indication and are being considered for an IPG replacement comprise the target population of this study. All subjects who meet the inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent will be considered enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject (and caregiver, if applicable) signed the approved Informed Consent;\n* Subject is ≥ 18 and ≤ 74 years of age;\n* Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus (STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigator's opinion;\n* In the physician's opinion, the subject is a suitable candidate for an IPG replacement with different stimulation paradigm;\n* Subject needs and/or requests an IPG replacement within 12 months after consent and the current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment;\n* PD symptom onset is no longer than 20 years;\n* Subject has a Hoehn \\& Yahr score \\<IV (on stim);\n* Subject with a normal cognitive function (MMSE ≥25);\n* Subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located.\n\nExclusion Criteria:\n\n* IPG battery has less than 30% battery life at the time of consent;\n* Need to replace or reposition the leads or extensions during the IPG replacement procedure;\n* Subject had \\>10 recurrent falls experienced in the 3 months prior to consent;\n* Subject is unwilling to change to either a St Jude Medical Infinity™ or Brio™ DBS system for the IPG replacement;\n* Subject is unable to attend the study visits."}, 'identificationModule': {'nctId': 'NCT02963259', 'acronym': 'PREFERENCE-H', 'briefTitle': 'IPG Replacement Study (PREFERENCE-H)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems', 'orgStudyIdInfo': {'id': 'SJM-CIP-10135'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system', 'description': 'Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system', 'interventionNames': ['Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system']}], 'interventions': [{'name': 'SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system', 'type': 'DEVICE', 'description': 'Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system', 'armGroupLabels': ['SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Kendall', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.67927, 'lon': -80.31727}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Neuroscience Consultants', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College at Albany Medical Ctr', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Gera', 'country': 'Germany', 'facility': 'Praxis Dr. Oehlwein', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'city': 'Halsbrücke', 'country': 'Germany', 'facility': 'Klinik am Tharandter Wald', 'geoPoint': {'lat': 50.95, 'lon': 13.35}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig AÖR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '44124', 'city': 'Ferrara', 'state': 'Cona', 'country': 'Italy', 'facility': 'Az.Osp. Universitaria Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Fondazione "Ospedale San Camillo" I.R.C.C.S', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Acquaviva delle Fonti', 'country': 'Italy', 'facility': 'Ospedale Generale Regionale F. Miulli', 'geoPoint': {'lat': 40.89704, 'lon': 16.8433}}, {'city': 'Mestre', 'country': 'Italy', 'facility': "Ospedale dell'Angelo", 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione Istituto Neurologico Nazionale C. Mondino', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Udine', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria S Maria della Misericordia', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Edward Karst', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}