Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02420158
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2015-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans-cutaneous Vagal Nerve Electrical Stimulation and 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)', 'timeFrame': '3 and 6 months after the beginning of electrical stimulation'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use', 'timeFrame': '6 months', 'description': 'Any symptom occurring in relation with electrical stimulation, number of hours per day of system use'}, {'measure': 'Evolution of digestive physiology during vagal nerve stimulation', 'timeFrame': '3 and 6 months', 'description': 'Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines'}, {'measure': 'Effect of vagal nerve stimulation on quality of life', 'timeFrame': '3 and 6 months', 'description': 'Quality of life and psychological questionnaires'}, {'measure': 'Evaluation of sympatho-vagal balance', 'timeFrame': '0, 3 and 6 months', 'description': 'Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Vagal nerve stimulation', 'Quality of life'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Short Communication BIOELECTRONICS IN MEDICINE Volume 3, 2020 - Issue 1 - Pages 5-12 Transcutaneous auricular vagus nerve stimulation for the treatment of irritable bowel syndrome: a pilot, open-label study Francois Mion*,1,2,3 , Sonia Pellissier4, Aur´ elien Garros1, Henri Damon1, Sabine Roman1,2,3 & Bruno Bonaz5,6,7 1Department of Digestive Physiology, Hospices Civils de Lyon, Lyon, France 2Department of Physiology, Universite´ de Lyon, Lyon, France 3Inserm U1032, LabTau, Lyon, France 4Universite´ Savoie Mont Blanc, Universite´ Grenoble Alpes, LIP/PC2S, 73000, Chambe´ ry 5Division of Hepato-Gastroenterology, CHU Grenoble Alpes, 38000 Grenoble, France 6Hepatogastroenterology, Universite´ Grenoble Alpes, Grenoble 7INSERM U1216, Grenoble Institute Neurosciences, Grenoble *Author for correspondence: francois.mion@chu-lyon.fr'}]}, 'descriptionModule': {'briefSummary': 'This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.\n\nThe safety of the electrical stimulation of the left vagal nerve will also be evaluated.\n\nTen women, age between 18 and 60, will be included.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 18-60,\n* clinical Rome III criteria for IBS\n\nExclusion Criteria:\n\n* pregnancy,\n* low intensity symptoms (Francis score between 75-150)\n* IBD, coeliac disease\n* past history of abdominal surgery (appendectomy and cholecystectomy allowed)\n* chronic use of analgesics, anti-depressants'}, 'identificationModule': {'nctId': 'NCT02420158', 'acronym': 'StVSII', 'briefTitle': 'Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life', 'orgStudyIdInfo': {'id': '2014.844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vagal nerve stimulation', 'description': 'Trans-cutaneous vagal nerve electrical stimulation during 6 months', 'interventionNames': ['Device: Trans-cutaneous vagal nerve electrical stimulation']}], 'interventions': [{'name': 'Trans-cutaneous vagal nerve electrical stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Vagal nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': "Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble", 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': "Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'François MION, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}