Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03496532
Status:
WITHDRAWN
Last Update Posted:
2021-08-13
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Parameters of Subthalamic Nucleus Stimulation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016012', 'term': 'Poisson Distribution'}], 'ancestors': [{'id': 'D016008', 'term': 'Statistical Distributions'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Different stimulation paradigm tested sequentially in every patient of the group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study stoped becaus it did not even start No willing from our colleagues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-04-05', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of quantity of Beta oscillations after biphasic pulses vs standard monophasic pulses', 'timeFrame': '10 minutes per patient', 'description': '% of changes in the energy of Beta oscillations'}, {'measure': 'Comparison of quantity of Beta oscillations after pseudo random (Poisson distribution) vs uniform distribution of pulse time intervals', 'timeFrame': '10 minutes per patient', 'description': '% of changes in the energy of Beta oscillations'}, {'measure': 'Observe the evolution of Beta oscillations during deep anesthesia', 'timeFrame': '2 minutes per patient', 'description': 'Energy of Beta oscillations'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Deep brain stimulation of the subthalamic nucleus is an effective treatment for Parkinson's disease. The analysis of cerebral signals of the subthalamic nucleus by local field potentials, provides one of the main electrophysiological markers of the success of the stimulation. This marker can be used to evaluate new paradigms of stimulation. So far, little studied, the temporal characteristics of the stimulation are very important in the effectiveness of the stimulation of the subthalamic nucleus, in Parkinson's disease. The first objective (Study I) is to compare the effectiveness of the stimulation when it is applied with biphasic symmetrical pulses and when applied with the standard pulses applied so far.\n\nThe second objective (Study II) is to see if, by applying pseudo-random time intervals between each stimulation pulse, if it would be possible to improve the efficiency and to limit the side effects of the stimulation.\n\nThe third objective (Study III) is to evaluate the electrophysiological changes of the subthalamic nucleus caused by the general anesthesia, in the anticipation of the realization of the surgery of the stimulation of the subthalamic nucleus under general anesthesia.", 'detailedDescription': 'Study I and II: Patients who participate undergo pulse generator change under sedation. Four sets of stimulation parameters will be compared. The efficacy of every set will be measured on induced changes in LFP recorded from the STN electrodes. LFP will be compared between before, during and right after each stimulation conditions. The stimulation order will be randomized. All other stimulation parameters will be the same (macrocontact with most beta-oscillations, 1 minute, 1.5mA) .\n\nStudy III: Patients who participate undergo their first pulse generator implantation, performed under general anesthesia because of wire tunnelisation. The depth of anesthesia will be documented, recording the BIS spectral analysis index. The difference in spectral amplitude density of LFP, in particular in beta band oscillations will be correlated with the depth of anesthesia as measured with the BIS index at the time of 2 minutes recordings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients suffering from Parkinson's disease, who must undergo surgery for the replacement of their neurostimulator (under sedation) or for the first positioning of it\n* capacity of discernment\n* informed signed consent\n\nExclusion Criteria:\n\n* Health considerations in regard to adding 13' in surgery room (e.g. pain or incomfort)."}, 'identificationModule': {'nctId': 'NCT03496532', 'briefTitle': 'Optimization of Parameters of Subthalamic Nucleus Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Optimization of Parameters of Subthalamic Nucleus Stimulation', 'orgStudyIdInfo': {'id': '2017-01832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulse generator change under sedation', 'description': 'The efficacy of every set will be measured on induced changes in LFP recorded from the STN electrodes.LFP will be compared between before, during and right after each stimulation conditions. The stimulation order will be randomized. All other stimulation parameters will be the same (macrocontact with most beta-oscillations, 1 minute, 1.5mA) .\n\nHence 4 sets of 1 minutes of STN stimulation will be performed, for:\n\nSymmetrical biphasic pulses versus standard pseudo monophasic pulses (study I; 2 sets).\n\nPseudorandom uniform distribution stimulation paradigms versus pseudorandom Poisson distribution stimulation paradigms (study II: 2 sets).', 'interventionNames': ['Device: biphasic stimulation', 'Device: standard stimulation', 'Device: Uniform distribution', 'Device: Poisson distribution']}, {'type': 'EXPERIMENTAL', 'label': 'First pulse generator implantation under general an', 'description': 'The depth of anesthesia will be documented, recording the BIS spectral analysis index. The difference in spectral amplitude density of LFP, in particular in beta band oscillations will be correlated with the depth of anesthesia as measured with the BIS index.', 'interventionNames': ['Device: Recordings of LFP oscillations']}], 'interventions': [{'name': 'biphasic stimulation', 'type': 'DEVICE', 'description': 'Fixed 70Hz symmetrical biphasic pulses', 'armGroupLabels': ['Pulse generator change under sedation']}, {'name': 'standard stimulation', 'type': 'DEVICE', 'description': 'Fixed 70Hz pseudo-monophasic pulses', 'armGroupLabels': ['Pulse generator change under sedation']}, {'name': 'Uniform distribution', 'type': 'DEVICE', 'description': 'Uniform distribution 70Hz Biphasic pulses', 'armGroupLabels': ['Pulse generator change under sedation']}, {'name': 'Poisson distribution', 'type': 'DEVICE', 'description': 'Poisson distribution 70Hz Biphasic pulses', 'armGroupLabels': ['Pulse generator change under sedation']}, {'name': 'Recordings of LFP oscillations', 'type': 'DEVICE', 'description': 'Two minutes of recordings of LFP oscillations will be performed from the contacts of the implanted electrode.\n\nRecordings of the depth of anaesthesia (BIS) all along the measurements performed under general anaesthesia.The correlation between the depth of anaesthesia and the cerebral oscillations recorded at the site of subthalamic nucleus will be studied.', 'armGroupLabels': ['First pulse generator implantation under general an']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colette Boex', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Colette Boex', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}