Transcutaneous Vagus Nerve Stimulation for Fibromyalgia Pain and Autonomic Dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores whether transcutaneous vagus nerve stimulation (tVNS) can improve pain and autonomic function in adults with fibromyalgia syndrome. Participants will receive active tVNS or sham stimulation in a controlled setting, allowing assessment of changes in symptoms and autonomic responses. The trial focuses on individuals with stable medications and excludes those with certain cardiovascular, systemic, or pregnancy-related risks. Outcomes will include patient-reported pain, fatigue, sleep, and objective autonomic measures. The study is conducted at the Department of Human Neuroscience in Rome under lead sponsorship at Università di Roma La Sapienza with collaboration from Policlinico Umberto I.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of fibromyalgia syndrome according to the 2016 ACR/EULAR classification criteria;
* Stable pharmacological treatment for at least 1 month before enrollment;
* Ability to understand and complete study procedures and questionnaires;
* Ability to provide written informed consent.

Exclusion Criteria:

* Presence of an active implantable medical device or any implanted metallic or electronic device near the ear or heart;
* History of severe coronary artery disease or myocardial infarction;
* Heart failure classified as New York Heart Association (NYHA) class II-IV;
* Cardiac arrhythmias or severe bradycardia;
* Carotid artery atherosclerosis;
* Chronic kidney disease stage II or higher;
* Concomitant immune-mediated rheumatic disease;
* Pregnancy;
* Active malignancy or previous malignancy not in remission;
* Ongoing infection;
* Changes in pharmacological treatment within 1 month before enrollment;
* Concomitant central or peripheral nervous system disorders, except isolated small-fiber pathology on skin biopsy;
* Cognitive impairment detected during neurological examination;
* Severe psychiatric comorbidities requiring specific treatment;
* Pain caused by other medical conditions that cannot be distinguished from fibromyalgia-related pain;
* Current or previous alcohol or substance abuse;
* Inadequate understanding of the Italian language.

Where it's running

• Department of Human Neuroscience
  Rome, Lazio, Italy Recruiting

Study contacts

• Principal investigator: Andrea Truini, MD, PhD — University of Roma La Sapienza
• Study coordinator: Pietro Falco, MD, PhD
• Email: pietro.falco@uniroma1.it
• Phone: +393462159105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.