Vagus nerve stimulation for fibromyalgia pain relief
Official title: Investigation of the Effects of Transcutaneous Vagus Nerve Stimulation on Fibromyalgia. A Double Blind, Sham-controlled Randomized Clinical Trial
Run by National and Kapodistrian University of Athens · NCT06912334 · Data updated 2026-11-12
This study is testing whether a device that stimulates the vagus nerve can help people with fibromyalgia feel less pain and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens, Greece) |
| Status | Recruiting |
| Started | October 15, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT06912334 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-79 diagnosed with fibromyalgia who experience moderate to high pain intensity.
✕Probably not a fit
Patients with significant cardiac arrhythmias or those unable to comply with the treatment regimen may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on patients with fibromyalgia, a chronic pain condition. The study employs a double-blind, sham-controlled design to assess the efficacy of tVNS in reducing pain intensity and improving quality of life. Participants will receive stimulation through a device that targets the vagus nerve, which is believed to play a role in pain modulation and autonomic regulation. The trial aims to provide insights into a non-pharmacological treatment option for fibromyalgia, addressing the limitations of current therapies.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective, and safe option for managing chronic pain in fibromyalgia patients.
How similar studies have gone: Previous studies on vagus nerve stimulation have shown promise in various conditions, suggesting potential for success in this novel application for fibromyalgia.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Women between 18-79 years old * Women diagnosed with Fibromyalgia according to the ACR 2016 Revised Classification Criteria * Moderate to high pain intensity according to analog pain scales (above 4 points over 10), for more than 6 months * Cognitive function sufficient to understand the experiments and follow instructions * Ability to read and understand all information on the device display. * Ability to adjust the strength of the stimulation or give feedback regarding their response to the device (feeling tingling/pulsating/pain). * Ability to comply with the recommended therapy regiment of 30 min per day. * The ear electrode needs to fit the patient. * Patients with physical or mental disabilities * The patient must be able to use the device by themselves or * The patients' caretaker can operate the device on the patient. In this case the patient --must still be able to give feedback regarding their response to the device Exclusion Criteria * Cardiac arrhythmias * Pregnancy * Serious mental disorder (dipolar disorder, schizophrenia etc.) * Prior injury to the vagus nerve * Individuals with scar tissue that may interfere with the stimulation * Presence of an electrically or magnetically activated implant
Where it's running
-
Aretaieion University Hospital
Athens, Greece, Greece Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.