Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT03548506
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2018-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subthalamic Steering for Therapy Optimization in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Electroencephalography', 'timeFrame': 'up to 6 months post-operatively', 'description': 'Electroencephalography (EEG)'}, {'measure': 'Electromyography', 'timeFrame': 'up to 6 months post-operatively', 'description': 'Electromyography (EMG)'}], 'primaryOutcomes': [{'measure': 'Muscle Rigidity', 'timeFrame': '6 months post-operatively', 'description': 'Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii'}], 'secondaryOutcomes': [{'measure': 'Clinical motor and non-motor symptoms (1)', 'timeFrame': '6 months post-operatively', 'description': 'MDS-UPDRS I'}, {'measure': 'Clinical motor and non-motor symptoms (2)', 'timeFrame': '6 months post-operatively', 'description': 'MDS-UPDRS II'}, {'measure': 'Clinical motor and non-motor symptoms (3)', 'timeFrame': '6 months post-operatively', 'description': 'MDS-UPDRS III'}, {'measure': 'Clinical motor and non-motor symptoms (4)', 'timeFrame': '6 months post-operatively', 'description': 'MDS-UPDRS IV'}, {'measure': 'Clinical motor and non-motor symptoms (5)', 'timeFrame': '6 months post-operatively', 'description': 'Bradykinesia evaluation'}, {'measure': 'Clinical motor and non-motor symptoms (6)', 'timeFrame': '6 months post-operatively', 'description': 'Tremor evaluation'}, {'measure': 'Clinical motor and non-motor symptoms (7)', 'timeFrame': '6 months post-operatively', 'description': 'Deep brain stimulation impairment scale (DBS-IS):\n\n* the scale consists of 22 questions and 6 subscales;\n* subscales: 1. postural instability and gait difficulties (range 0-20), 2. cognitive impaiment (range 0-20), 3. speaking problems (range 0-12), 4. apathy (range 0-12), 5. impulsivity (range 0-12), and 6. difficulties related to DBS device (range 0-12);\n* Ʃ 1-6 DBS-IS total range: 0-88;\n* Ʃ 1-5 DBS-IS total range: 0-76;\n* higher values represent worsening of symptoms'}, {'measure': 'Clinical motor and non-motor symptoms (8)', 'timeFrame': '6 months post-operatively', 'description': 'Clinical global impression self'}, {'measure': 'Neurocognitive and non-motor symptoms (1)', 'timeFrame': '6 months post-operatively', 'description': 'Modulation range'}, {'measure': 'Neurocognitive and non-motor symptoms (2)', 'timeFrame': '6 months post-operatively', 'description': 'Spatial with a visual Odd-Ball test'}, {'measure': 'Neurocognitive and non-motor symptoms (3)', 'timeFrame': '6 months post-operatively', 'description': 'Verbal Working Memory with an auditory Odd-Ball test'}, {'measure': 'Neurocognitive and non-motor symptoms (4)', 'timeFrame': '6 months post-operatively', 'description': 'Power of Attention (Cognitive Drug Research Battery)'}, {'measure': 'Neurocognitive and non-motor symptoms (5)', 'timeFrame': '6 months post-operatively', 'description': 'Digit Vigilance Accuracy (Cognitive Drug Research Battery)'}, {'measure': 'Neurocognitive and non-motor symptoms (6)', 'timeFrame': '6 months post-operatively', 'description': 'Executive functions with One Touch Tower of London (Cambridge Neuropsychological Test Automated Battery, CANTAB)'}, {'measure': 'Neurocognitive and non-motor symptoms (7)', 'timeFrame': '6 months post-operatively', 'description': 'Montreal Cognitive Assessment (MoCA)'}, {'measure': 'Neuropsychiatric symptoms (1)', 'timeFrame': '6 months post-operatively', 'description': 'Beck Depression Inventory (BDI)'}, {'measure': 'Neuropsychiatric symptoms (2)', 'timeFrame': '6 months post-operatively', 'description': 'Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory'}, {'measure': 'Freezing of gait (1)', 'timeFrame': '6 months post-operatively', 'description': 'Capsit-PD'}, {'measure': 'Freezing of gait (2)', 'timeFrame': '6 months post-operatively', 'description': 'Freezing of Gait Assessment Course'}, {'measure': 'Quality of life', 'timeFrame': '6 months post-operatively', 'description': "Parkinson's Disease Questionaire (PDQ-39)"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['STN', 'DBS', 'steering', 'segmented electrode leads'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '18855925', 'type': 'BACKGROUND', 'citation': 'Levin J, Krafczyk S, Valkovic P, Eggert T, Claassen J, Botzel K. Objective measurement of muscle rigidity in Parkinsonian patients treated with subthalamic stimulation. Mov Disord. 2009 Jan 15;24(1):57-63. doi: 10.1002/mds.22291.'}, {'pmid': '39461964', 'type': 'DERIVED', 'citation': "Gharabaghi A, Cebi I, Leavitt D, Scherer M, Bookjans P, Brunnett B, Milosevic L, Weiss D. Randomized crossover trial on motor and non-motor outcome of directional deep brain stimulation in Parkinson's disease. NPJ Parkinsons Dis. 2024 Oct 26;10(1):204. doi: 10.1038/s41531-024-00812-0."}]}, 'descriptionModule': {'briefSummary': "Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus \\[STN\\_O\\] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact \\[STN\\_D\\].", 'detailedDescription': 'Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation \\[STN\\_D\\] compared with standard omnidirectional STN stimulation \\[STN\\_O\\]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P \\< 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Idiopathic Parkinson\'s disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms\n\nExclusion Criteria:\n\n* Cognitive impairment (Mini Mental State Exam \\< 20)\n* Suicidality, Psychosis\n* Other severe pathological chronic condition that might confound treatment effects or interpretation of the data\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03548506', 'acronym': 'SANTOP', 'briefTitle': "Subthalamic Steering for Therapy Optimization in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': "Subthalamic Steering for Therapy Optimization in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'SANTOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'STN_O', 'description': 'Omnidirectional Deep Brain Stimulation of STN', 'interventionNames': ['Device: Omnidirectional Deep Brain Stimulation of STN']}, {'type': 'EXPERIMENTAL', 'label': 'STN_D', 'description': 'Directional Deep Brain Stimulation of STN', 'interventionNames': ['Device: Directional Deep Brain Stimulation of STN']}], 'interventions': [{'name': 'Omnidirectional Deep Brain Stimulation of STN', 'type': 'DEVICE', 'description': 'Deep Brain Stimulation', 'armGroupLabels': ['STN_O']}, {'name': 'Directional Deep Brain Stimulation of STN', 'type': 'DEVICE', 'description': 'Deep Brain Stimulation', 'armGroupLabels': ['STN_D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases)', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Alireza Gharabaghi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tuebingen, Germany'}, {'name': 'Daniel Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department for Neurodegenerative Diseases, Centre for Neurology, Tuebingen, Germany, and Hertie-Institute for Clinical Brain Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Dr. Alireza Gharabaghi', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}