Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-28 @ 12:38 PM
Study NCT ID:
NCT05255692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2022-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activated brain regions demonstrating brain activity', 'timeFrame': 'through study completion, an average of 6 weeks', 'description': 'fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder control', 'functional magnetic resonance imaging'], 'conditions': ['fMRI Research']}, 'descriptionModule': {'briefSummary': 'Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).\n\nHigher brain centers responsible for bladder function may be related to the presence of incontinence.\n\nThe current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.', 'detailedDescription': 'Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.\n\nHigher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.\n\nThe current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* lower or upper urinary tract dysfunction'}, 'identificationModule': {'nctId': 'NCT05255692', 'briefTitle': 'Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research', 'orgStudyIdInfo': {'id': 'BC-10572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complete evaluation UDO and fMRI', 'description': 'Evaluation including both urodynamic evaluation and functional MRI testing', 'interventionNames': ['Diagnostic Test: invasive urodynamic evaluation', 'Diagnostic Test: functional magnetic resonance imaging during bladder filling']}], 'interventions': [{'name': 'invasive urodynamic evaluation', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['UDO'], 'description': 'Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured.', 'armGroupLabels': ['Complete evaluation UDO and fMRI']}, {'name': 'functional magnetic resonance imaging during bladder filling', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['fMRI'], 'description': 'Functional MRI is used to capture brain activity during tasks. The task in the current study is bladder infusion and withdrawal by means of the INFSYS-2 infusion/withdrawal pump (Leitner et al. 2017)', 'armGroupLabels': ['Complete evaluation UDO and fMRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Flanders', 'country': 'Belgium', 'contacts': [{'name': 'Bieke Samijn, PhD', 'role': 'CONTACT', 'email': 'bieke.samijn@ugent.be', 'phone': '+3293321938'}], 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Bieke Samijn, PhD', 'role': 'CONTACT', 'email': 'bieke.samijn@ugent.be', 'phone': '+3293321938'}], 'overallOfficials': [{'name': 'Bieke Samijn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}