Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-03-26 @ 7:28 AM
Study NCT ID:
NCT00859859
Status:
TERMINATED
Last Update Posted:
2011-07-20
First Post:
2009-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vagus Nerve Stimulation in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'The protocol was terminated early (prior to complete enrollment) after interim analysis proved data to be statistically insignificant', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2009-03-10', 'studyFirstSubmitQcDate': '2009-03-10', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of short-term and medium-term effects of vagus nerve intervention with endpoints such as autonomic function, cytokine synthesis, inflammatory markers as well as disease activity score and global health measurement in subjects', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '32232095', 'type': 'DERIVED', 'citation': 'Addorisio ME, Imperato GH, de Vos AF, Forti S, Goldstein RS, Pavlov VA, van der Poll T, Yang H, Diamond B, Tracey KJ, Chavan SS. Investigational treatment of rheumatoid arthritis with a vibrotactile device applied to the external ear. Bioelectron Med. 2019 Apr 17;5:4. doi: 10.1186/s42234-019-0020-4. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the short-term effects of vagus nerve stimulation (VNS) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which innervates the ear) in rheumatoid arthritis (RA). RA is characterized by a chronic systemic inflammation affecting the joints but also carries an increased risk for extra-articular manifestations as well as other organ manifestations such as cardiovascular disease (CVD), which significantly contributes to morbidity and mortality in this disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a diagnosis of RA based on the ACR guidelines. Disease activity measured as activity score (DAS-28 CRP) will be used\n2. None of the exclusion criteria (see below).\n\nExclusion Criteria:\n\n1. Minors (\\<18 years of age) and mentally incompetent individuals\n2. One or more of the following conditions: immunosuppressive condition (which includes malignancy, chronic alcoholism, diabetes), severe chronic dementia, psychiatric illness with active psychosis, current intravenous or other serious illicit drug use\n3. Pregnancy\n4. Terminal status referred for palliative care only\n5. Homeless status\n6. IDDM and NIDDM patients will not be enrolled in this study\n7. Previous history of ischemic cardiovascular disease including myocardial infarction, unstable angina, and bradytachyarrythmias\n8. Moderate or severe anemia. Hemoglobin levels will be determined at screening. A cut-off level of \\< 10 mg/dL in women and \\< 11 mg/dL in men is selected.\n9. Smoking\n10. Subjects taking concomitant medications potentially affecting autonomic function such as anti-cholinergic medications and beta-blockers.'}, 'identificationModule': {'nctId': 'NCT00859859', 'briefTitle': 'Vagus Nerve Stimulation in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Vagus Nerve Stimulation in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'GCRC 0137'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vagus Nerve Stimulation', 'type': 'DEVICE', 'description': '1. Vagus nerve stimulation for 5 minutes with an oscillatory device (Brookstone) used in previous experimental animal studies for stimulating the vagus nerve on the neck by carotid massage. The oscillatory part of this pen-like device is approximately 0,5 cm2.\n2. Basic lab tests (metabolic panel and CBC with differential) and monocyte cytokine synthesis and other inflammatory markers will be analyzed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'The Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Kevin J Tracey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kevin J. Tracey. MD', 'oldOrganization': 'The Feinstein Institute for Medical Research'}}}}