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

RecruitingNAAges 18 Years - 79 YearsFemaleNational and Kapodistrian University of Athens
NCT06912334 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Stimulation of the vagus nerve, a parasympathetic nerve that controls the digestive, the vascular and immune systems, produces pain relief in various clinical conditions. Transmission via vagal afferents to the nucleus of the solitary tract has been proposed as the primary physiological mechanism that reduces pain intensity following vagal stimulation. Medication is one of the pillars of dealing with chronic pain, with several benefits, but also side effects. Fibromyalgia is an idiopathic chronic pain syndrome with few, effective and safe treatments. However, current research in the field of vagal innervation suggests psychophysiological and electrical ways by which the syndrome may be treated.The chronic pain symptoms of fibromyalgia patients may benefit from vagus nerve stimulation, by normalizing the autonomic and immune system dysfunction that causes their respective symptoms. Howeve

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📋 Eligibility rules (as published)
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
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What it tests

  • tVNS
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Where

1 site
Aretaieion University Hospital
Athens, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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