Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-28 @ 8:31 AM
Study NCT ID:
NCT06009159
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A modified McGill Pain Questionnaire', 'timeFrame': 'at 0,4, weeks of the study,', 'description': 'Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain'}], 'secondaryOutcomes': [{'measure': 'Multidimensional Fatigue Inventory', 'timeFrame': 'at 0,4,8 weeks of the study', 'description': 'Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.'}, {'measure': 'Medical Outcomes Study Sleep Scale', 'timeFrame': 'at 0,4,8 weeks of the study', 'description': 'sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time'}, {'measure': 'Revised Fibromyalgia Impact Questionnaire', 'timeFrame': 'at 0,4,8 weeks of the study', 'description': 'Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact'}, {'measure': 'Medical Outcomes Study Questionnaire Short Form 36', 'timeFrame': 'at 0, 4, 8 weeks of the study', 'description': 'Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.'}, {'measure': 'Blood inflammation marker', 'timeFrame': 'at 0, 4, 8 weeks of the study', 'description': 'collect blood sample for cytokines level'}, {'measure': 'Assessment of gut microbiome changes through genomic phenotypic', 'timeFrame': 'at 0, 4, 8 weeks of the study', 'description': 'collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vagus nerve stimulation,', 'pain', 'fibromyalgia symptoms'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '31637517', 'type': 'BACKGROUND', 'citation': 'Moisset X, Lanteri-Minet M, Fontaine D. Neurostimulation methods in the treatment of chronic pain. J Neural Transm (Vienna). 2020 Apr;127(4):673-686. doi: 10.1007/s00702-019-02092-y. Epub 2019 Oct 21.'}, {'pmid': '26364692', 'type': 'BACKGROUND', 'citation': 'Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14.'}, {'pmid': '33114203', 'type': 'BACKGROUND', 'citation': 'Maffei ME. Fibromyalgia: Recent Advances in Diagnosis, Classification, Pharmacotherapy and Alternative Remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877. doi: 10.3390/ijms21217877.'}]}, 'descriptionModule': {'briefSummary': 'Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.', 'detailedDescription': 'The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is 18 to 80 years old, including both male and female subjects.\n2. Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.\n3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).\n\nExclusion Criteria:\n\n1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.\n2. Subject has major psychiatric disorder required hospitalization in the last 3 months.\n3. Subject has active infection at the site of device application.\n4. Subject has recurrent syncope symptoms within the past three months.\n5. Subject is pregnant.\n6. Subject has had VNS treatment within the past two months.\n\n .'}, 'identificationModule': {'nctId': 'NCT06009159', 'briefTitle': 'Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients', 'orgStudyIdInfo': {'id': '2023P001211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Vagus Nerve Stimulation(tVNS)', 'description': 'receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.', 'interventionNames': ['Device: Transcutaneous Vagus Nerve Stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Sham Control group', 'description': 'receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.'}], 'interventions': [{'name': 'Transcutaneous Vagus Nerve Stimulation', 'type': 'DEVICE', 'description': '30 minutes stimulation, twice per day for 4 weeks', 'armGroupLabels': ['Transcutaneous Vagus Nerve Stimulation(tVNS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucy Chen, M.D.', 'role': 'CONTACT', 'email': 'llchen@mgh.harvard.edu', 'phone': '617-724-6102'}, {'name': 'Jianren Mao, M.D.', 'role': 'CONTACT', 'email': 'jmao@mgh.harvard.edu', 'phone': '617-724-6102'}, {'name': 'Lucy Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lucy Chen, M.D.', 'role': 'CONTACT', 'email': 'llchen@mgh.harvard.edu', 'phone': '617-724-3466'}, {'name': 'Jianren Mao, M.D.', 'role': 'CONTACT', 'email': 'jmao@mgh.harvard.edu', 'phone': '617-726-2338'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lucy Chen', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}