NCT07904351|Not Yet RecruitingFDA Device
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
R61VNS
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R61VNS
Sponsor study identifier
Secondary identifiers
interventional
105
1 country
1
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Fibromyalgia is a syndrome with clinical symptoms that affect multiple systems of the body. Although basic science research and clinical research trials have been carried out, the cause and the mechanism of fibromyalgia are still unknown. The goal of current medical treatment is to relieve symptoms and improve quality of life. Recent clinical and experimental studies have shown that stimulation of the vagus nerve has a potential to help pain syndromes. In this study, we aim to evaluate the effects of using transcutaneous vagus nerve stimulation (tVNS) on treating pain and other symptoms in fibromyalgia patients. We will do this by using the VagaCalm device.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)July 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Score
The SF-MPQ-2 assesses pain quality and intensity across multiple pain domains and includes a general pain intensity rating. Participants rate pain severity on a scale from 0 (none) to 10 (worst possible). Higher scores indicate greater pain severity.
Week 0 and Week 6
Multidimensional Fatigue Inventory
Week 0 and Week 6
Revised Fibromyalgia Impact Questionnaire (FIQR) Total Score
Week 0 and Week 6
Supplemental Gastrointestinal Symptom Questionnaire Score
Week 0 and Week 6
Empirical Dietary Inflammatory Index (EDII) Score
Week 0 and Week 6
Medical Outcomes Study Questionnaire Short Form 36 (SF-36)
Week 0 and Week 6
Receive tVNS 30 minutes per session, twice/day for 6 weeks and maintain regular medication treatment without change. Post study follow up will occur 2 weeks after completing the 6-week treatment.
Receive sham point stimulation 30 minutes per session, twice/day for 6 weeks and maintain regular medication treatment without change. Post study follow up will occur 2 weeks after completing the 6-week treatment.
30 minutes stimulation, twice per day for 6 weeks
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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.
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.
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.
Lucy Chen, M.D.
Massachusetts General Hospital
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Clinical Impact of Integrated Behavioral Health Techniques in Patients With Fibromyalgia
Contact the study team to confirm eligibility.
Primary Completion
July 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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