Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00610233
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2008-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Deep Brain Stimulation on Lower Urinary Tract Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-18', 'studyFirstSubmitDate': '2008-01-24', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of deep brain stimulation (DBS) on urodynamic parameters', 'timeFrame': 'immediately and 3 months after study inclusion'}], 'secondaryOutcomes': [{'measure': 'Changes in questionnaire data due to deep brain stimulation (DBS)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deep brain stimulation', 'urodynamics'], 'conditions': ['Movement Disorder', 'Urinary Tract Disease']}, 'descriptionModule': {'briefSummary': 'The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function.\n\nWe hypothesize that DBS has a significant effect on LUT function and that these effects depend on the specific stimulated cerebral center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with deep brain stimulation (DBS)\n\nExclusion Criteria:\n\n* Pregnancy\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT00610233', 'briefTitle': 'Effect of Deep Brain Stimulation on Lower Urinary Tract Function', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function', 'orgStudyIdInfo': {'id': 'KEK 33/05'}, 'secondaryIdInfos': [{'id': '1005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Urodynamic investigation with deep brain stimulation ON', 'interventionNames': ['Procedure: deep brain stimulation ON']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Urodynamics with deep brain stimulation OFF', 'interventionNames': ['Procedure: Deep brain stimulation OFF']}], 'interventions': [{'name': 'deep brain stimulation ON', 'type': 'PROCEDURE', 'description': 'deep brain stimulation in the ON state', 'armGroupLabels': ['A']}, {'name': 'Deep brain stimulation OFF', 'type': 'PROCEDURE', 'description': 'Urodynamic investigation with deep brain stimulation in the OFF state', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Neurology, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Urology, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Thomas M Kessler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, University of Bern, 3010 Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thomas M. Kessler, MD', 'oldOrganization': 'Department of Urology, University of Bern, 3010 Switzerland'}}}}