Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00213356
Status:
WITHDRAWN
Last Update Posted:
2013-06-18
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Nervous Control of the Anal Sphincter
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'patients with neurological disease not included', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2004-03'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal cord injuries - anal sphincter - evoked potentials'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Anal incontinence and constipation are frequently observed in patients with neurological disease. The purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. This technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volunteers patients with spinal lesion patients with cauda equina syndrome', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* patients with spinal lesion\n* patients with cauda equina syndrome\n\nExclusion Criteria:\n\n* pregnant women\n* pacemaker or other metallic material implanted\n* epileptic patients\n* organic colorectal disease\n* obese patients\n* previous neurological surgery'}, 'identificationModule': {'nctId': 'NCT00213356', 'briefTitle': 'Study of the Nervous Control of the Anal Sphincter', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Evoked Responses of External Anal Sphincter After Cortical and Lombo-sacral Magnetic Stimulations', 'orgStudyIdInfo': {'id': '2001/099/HP'}}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'University hospital of Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Anne-Marie LEROI, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}