Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial

Launched by NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS · Mar 30, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for fibromyalgia, a condition that causes chronic pain and often has limited treatment options. The study focuses on using a technique called transcutaneous vagus nerve stimulation (tVNS), which involves gently stimulating a nerve in the ear that may help reduce pain and improve the quality of life for patients. This trial will compare two groups of women with fibromyalgia: one group will receive standard medication along with active tVNS, while the other group will receive the same medication but with a sham (inactive) stimulation. The goal is to see if adding tVNS to their treatment helps relieve pain more effectively.

Women aged 18 to 79 who have been diagnosed with fibromyalgia and experience moderate to high pain levels may be eligible to participate. Participants will attend 14 sessions over two weeks, with each session lasting 30 minutes. Throughout the trial, they will be asked to provide feedback about their experience with the stimulation. This study is important because it explores non-invasive ways to manage chronic pain and could lead to new treatment options for fibromyalgia in the future.

Gender

FEMALE

Eligibility 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