Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia
Key facts
- Who runs it
- Hatice Betigul Meral
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 1 Aug 2025
- Ended
- 10 Oct 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
- Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Record updated
- 15 January 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age between 18 and 65 years
- Diagnosis of fibromyalgia according to the 2016 revised ACR criteria
- Receiving stable pharmacological and/or non-pharmacological treatment for at least 3 months
- Ability to understand study procedures and provide informed consent
Who cannot take part
- History of epilepsy or cardiac arrhythmia
- Acute or chronic infection
- Heart failure (NYHA class II-IV)
- Renal failure stage II or higher
- Active malignancy
- Psychotic disorders or current psychiatric treatment
- Diagnosis of immune-mediated rheumatic disease
- Pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and sensitivity to touch. Current treatments often provide only partial relief. This study evaluates a non-invasive technique called transcutaneous auricular vagus nerve stimulation (TaVNS), which delivers gentle electrical impulses to a part of the ear connected to the vagus nerve. The vagus nerve plays an important role in regulating pain, stress, and autonomic body functions such as sleep.
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In this randomized controlled pilot trial, participants with fibromyalgia are assigned to receive either active TaVNS or sham (placebo) stimulation for 30 minutes per day, five days per week, over a four-week period. Participants are followed for a total of 8 weeks. The investigators will assess outcomes including pain intensity, sleep quality, central sensitization, and fear of movement (kinesiophobia).
The 2 groups in the trial
- Active TaVNSTreatment being tested
Participants received active transcutaneous auricular vagus nerve stimulation (TaVNS) using the VagusStim® device (Vagus Medical Technologies, Istanbul, Türkiye). The electrode was placed on the left cymba concha and stimulation was applied for 30 minutes per day, 5 days per week, over 4 weeks (20 sessions). Stimulation parameters included 1-30 Hz frequency, 50-250 μs pulse width, and current individually adjusted (0.1-36 mA) to each participant's sensory threshold.
Treatment: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
- Sham TaVNSPlacebo, for comparison
Participants underwent sham stimulation using the same VagusStim® device under identical conditions. The electrode was placed on the left earlobe, an area without vagal innervation, and sessions lasted 30 minutes per day, 5 days per week, for 4 weeks. No effective vagus nerve stimulation was delivered, maintaining participant blinding.
Treatment: Sham Transcutaneous Auricular Vagus Nerve Stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia: A Randomized Controlled Trial
- Record updated
- 15 January 2026