An interventional study of Transcutaneous Vagus Nerve Stimulation in Fibromyalgia, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has had VNS treatment within the past two months.
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receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
Device: Transcutaneous Vagus Nerve Stimulation
receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
30 minutes stimulation, twice per day for 4 weeks
A modified McGill Pain Questionnaire
Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
Time frame: at 0,4, weeks of the study,
Multidimensional Fatigue Inventory
Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.
Time frame: at 0,4,8 weeks of the study
Medical Outcomes Study Sleep Scale
sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
Time frame: at 0,4,8 weeks of the study
Revised Fibromyalgia Impact Questionnaire
Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
Time frame: at 0,4,8 weeks of the study
Medical Outcomes Study Questionnaire Short Form 36
Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.
Time frame: at 0, 4, 8 weeks of the study
Blood inflammation marker
collect blood sample for cytokines level
Time frame: at 0, 4, 8 weeks of the study
Assessment of gut microbiome changes through genomic phenotypic
collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome
Time frame: at 0, 4, 8 weeks of the study
Plan to share: No
Started Jul 2024 (actual). Primary completion is estimated for Jul 2029, 60 months after the start.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 60 months is above that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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