Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04577651
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2020-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cartesia eXTend 3D Study
Sponsor:
Organization:
Raw JSON
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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Basal ganglia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fine motor skill dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dopamine dysregulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 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Higher scores indicate worse function."}, {'measure': 'Change in Quality of Life', 'timeFrame': '12 weeks post device-activation', 'description': "Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health."}, {'measure': 'Change in Quality of Life', 'timeFrame': '26 weeks post device-activation', 'description': "Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 26 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health."}, {'measure': 'Change in Quality of Life', 'timeFrame': '52 weeks post device-activation', 'description': "Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 52 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health."}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).", 'detailedDescription': "Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Candidate for DBS implant in the treatment of Parkinson\'s disease\n* Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent\n* Persistent disabling Parkinson\'s disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy\n* Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).\n\nKey Exclusion Criteria:\n\n* Any intracranial abnormality or medical condition that would contraindicate DBS surgery\n* Have any significant psychiatric or cognitive condition likely to compromise the subject\'s ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)\n* Any current drug or alcohol abuse, as determined by the investigator\n* Any history of recurrent or unprovoked seizures'}, 'identificationModule': {'nctId': 'NCT04577651', 'acronym': 'eXTend 3D', 'briefTitle': 'Cartesia eXTend 3D Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': "Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)", 'orgStudyIdInfo': {'id': 'A4092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '16-contact Directional Deep Brain Stimulation', 'description': 'Deep Brain Stimulation with a 16-contact Directional Lead', 'interventionNames': ['Device: 16-contact Directional Deep Brain Stimulation']}], 'interventions': [{'name': '16-contact Directional Deep Brain Stimulation', 'type': 'DEVICE', 'description': 'Deep Brain Stimulation with 16-contact Directional Lead', 'armGroupLabels': ['16-contact Directional Deep Brain Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'University Berlin, Charite Virchow Standort, Wedding', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinik Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitaetsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Giessen und Marburg GmbH', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'UMC St. Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St. Georges Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Natalie Bloom Lyons', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Neuromodulation Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}