Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-31 @ 5:50 AM
Study NCT ID:
NCT00011557
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Magnetic Micturition in Patients w/SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007316', 'term': 'Insemination, Artificial, Heterologous'}], 'ancestors': [{'id': 'D007315', 'term': 'Insemination, Artificial'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007314', 'term': 'Insemination'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-01', 'completionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2001-02-22', 'studyFirstSubmitQcDate': '2001-02-23', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-02-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Bladder, electromagnetic fields, Spinal cord injury'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.', 'detailedDescription': 'Investigators intend to determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.\n\nThirty six persons will be recruited and will undergo an 8 week protocol for conditioning of the bladder. The investigators propose to: investigate the changes in bladder function in response to long-term bladder conditioning by FMS; further optimize the FMS technology and parameters for effective bladder emptying in SCI; evaluate the role of the external sphincter muscle fatigue by FS in facilitating bladder emptying; critically evaluate the relative response of FMS data to existing information using functional electrical stimulation;further develop criteria that will be used to predict which SCI patients are optimally suitable for FMS; establish a comprehensive stimulation criteria that will reflect the safety and effectiveness of structures associated with the bladder that are exposed to the electro-myographic field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with SCI above T10 level, six months post injury'}, 'identificationModule': {'nctId': 'NCT00011557', 'briefTitle': 'Functional Magnetic Micturition in Patients w/SCI', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Functional Magnetic Micturition in Patients w/SCI', 'orgStudyIdInfo': {'id': 'B1747R'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assistance in Voiding', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VAMC, Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'overallOfficials': [{'name': 'John Fryer, Ph.D. Asst. Director', 'affiliation': 'Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service'}, {'name': 'Nancy Rocheleau, Program Analyst', 'affiliation': 'Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}}}}