Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01801605
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2009-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-28', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain or discomfort threshold volumes', 'timeFrame': 'final (up to 5 days)'}], 'secondaryOutcomes': [{'measure': 'Amplitude of R3 reflex'}, {'measure': 'Visual analogic scale'}, {'measure': 'Symptoms diary'}, {'measure': 'Quality of life scores'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IBS - rectal hypersensitivity - rectal barostat - rTMS.'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study.', 'detailedDescription': 'IBS patients frequently demonstrate a rectal hypersensitivity which could participate to the abdominal pain. rTMS is an effective treatment of neurogenic chronic pain. The aim of the study is to evaluate the efficacy of rTMS on rectal hypersensitivity in patients with IBS in a prospective, randomized, double-blind study.\n\nPatients and method: 20 patients with rectal hypersensitivity secondary to IBS will have one active session of rTMS located on the cortical area of the abdominal muscles during 5 consecutive days and one session of simulated rTMS during 5 over consecutive days corresponding to the placebo session. The order of the two session will be randomized. The efficacy of rTMS will be assessed by a rectal barostat to determine the pain or discomfort threshold and by a RIII reflex. The barostat and RIII reflex will be performed at the beginning and at the end of each session.\n\nThe investigators hope to demonstrate an improvement of the rectal hypersensitivity during the active stimulations compared to the placebo one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 18 years old\n* IBS defined by Rome III criteria\n* Rectal hypersensitivity evaluated by barotat with a pain or inconfort volume less than 28 mmHg\n* IBS for more than 3 months\n* With an organic exploration for less than 6 months\n* Without any knowledge concerning the rTMS\n\nExclusion Criteria:\n\n* Pregnant women or women without any contraception\n* Patients with pace-maker or other metallic implant\n* Patients complaining of epilepsia or with past of epilepsia\n* Patients with psychiatric disorders\n* Patients treated by any drugs which could interfere with rTMS\n* Patients having participate to another protocol within the month preceeding the inclusion\n* Patients who could not stop the antalgic drugs within the week preceeding the onset of the study\n* patients with a significant lesion on RMI.'}, 'identificationModule': {'nctId': 'NCT01801605', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?', 'orgStudyIdInfo': {'id': '2007/053/HP'}, 'secondaryIdInfos': [{'id': '2007-A00799-44'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'on', 'description': 'active session', 'interventionNames': ['Procedure: rTMS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'off', 'description': 'fictive session', 'interventionNames': ['Procedure: rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'PROCEDURE', 'otherNames': ['Active:A', 'Placebo:B'], 'description': 'Active session with stimulation and placebo session with fictive stimulation', 'armGroupLabels': ['off', 'on']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'country': 'France', 'facility': 'Physiology Unit-Rouen university Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Anne-Marie Leroi, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}