An interventional study of Transcutaneous Vagus Nerve Stimulation in Fibromyalgia, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
Fibromyalgia is a chronic condition that can cause widespread pain, fatigue, sleep problems, anxiety, and depression. While current treatments can help manage symptoms, many people continue to experience significant discomfort and reduced quality of life.
This study will evaluate whether transcutaneous vagus nerve stimulation (tVNS), a non-invasive therapy that delivers mild electrical stimulation to the outer ear, can help reduce pain and other symptoms in people with fibromyalgia. The vagus nerve helps regulate communication between the brain and the body and may play a role in pain processing.
A total of 105 participants will take part in this 6-week study. Participants will receive either active tVNS treatment or a sham (inactive) treatment for comparison. Researchers will assess changes in pain and other fibromyalgia-related symptoms using questionnaires and pain sensitivity testing. Additional assessments will include pressure pain testing, mechanical pain sensitivity testing using Von Frey filaments, dietary questionnaires, the Bristol Stool Chart, and stool sample collection.
The study will also measure levels of intestinal alkaline phosphatase (IAP) in stool samples to investigate whether IAP could serve as a biomarker for fibromyalgia and whether it may be associated with symptom severity or response to treatment. Participants will complete a follow-up phone call approximately 8 weeks after enrollment to assess pain levels and any side effects.
The findings may improve understanding of fibromyalgia, help identify potential biological markers of the condition, and evaluate a non-invasive treatment approach for symptom management.
1,375 studies on the registry are indexed under Fibromyalgia; 275 are open to participants now.
This study's planned enrollment of 105 is above the median of 60 across 1,060 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Massachusetts General Hospital is the lead sponsor of 2,584 studies on the registry; 448 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
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.
Device: Transcutaneous Vagus Nerve Stimulation
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
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.
Time frame: Week 0 and Week 6
Multidimensional Fatigue Inventory
The Multidimensional Fatigue Inventory (MFI-20) is a 20-item self-report questionnaire that assesses general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Participants rate statements using a 5-point Likert scale. Higher total scores indicate greater fatigue.
Time frame: Week 0 and Week 6
Revised Fibromyalgia Impact Questionnaire (FIQR) Total Score
The Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item self-report measure assessing fibromyalgia-related function, overall impact, and symptoms during the previous 7 days. Total scores range from 0 to 100, with higher scores indicating greater fibromyalgia symptom burden and functional impairment.
Time frame: Week 0 and Week 6
Supplemental Gastrointestinal Symptom Questionnaire Score
The Supplemental Gastrointestinal Symptom Questionnaire assesses gastrointestinal symptoms, including abdominal pain, bloating, abnormal bowel movements, irritable bowel syndrome diagnosis, and stool characteristics. Higher scores indicate greater gastrointestinal symptom burden.
Time frame: Week 0 and Week 6
Empirical Dietary Inflammatory Index (EDII) Score
The Empirical Dietary Inflammatory Index (EDII) is a dietary assessment questionnaire that evaluates the inflammatory potential of dietary intake based on the frequency of consumption of specific food and beverage categories. Higher scores indicate a more pro-inflammatory dietary pattern.
Time frame: Week 0 and Week 6
Medical Outcomes Study Questionnaire Short Form 36 (SF-36)
The SF-36 is a 36-item self-report measure of health-related quality of life assessing physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Higher scores indicate better health status and quality of life.
Time frame: Week 0 and Week 6
Medical Outcomes Study (MOS) Sleep Scale Score
The MOS Sleep Scale is a 12-item self-report questionnaire that assesses sleep disturbance, sleep adequacy, daytime somnolence, sleep quantity, and other sleep-related problems experienced during the previous 4 weeks. Higher scores indicate greater sleep disturbance and poorer sleep quality.
Time frame: Week 0 and Week 6
Blood inflammation marker
Collect blood samples for cytokine level assessment.
Time frame: Week 0 and Week 6
Assessment of Gut Microbiome Changes Through Genomic and Phenotypic Analysis
Collect stool samples to analyze bacterial composition and metabolomic profiles of the gut microbiome.
Time frame: Week 0 and Week 6
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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