NCT06912334 Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial
| NCT ID | NCT06912334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Transcutaneous Vagus Nerve Stimulation on Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-10-15 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. However, the effects of multiple sessions of transcutaneous vagus nerve stimulation (tVNS) in fibromyalgia have not been evaluated in randomized clinical trials. The hypothesis of our study is to evaluate if the addition of transcutaneous stimulation of the auricular branch of the vagus nerves in patients with fibromyalgia, can lead to better pain control and quality of life. We will offer a 2-week treatment (14 sessions of 30 minutes) in a randomized double-blind controlled trial. The sample of the study, which will be conducted in the pain clinic of the Aretaieion University General Hospital, will be consisted of 120 patients, who will be divided into 2 groups (1st group: standard pharmacological treatment + active tVNS, 2nd group: standard pharmacological treatment + sham tVNS). The study is designed to determine, if standard pharmacological treatment combined with 14 sessions of tVNS is able to improve pain symptomatology in fibromyalgia and all symptoms of this syndrome, by using appropriate scales. This study examines a new and potentially impactful way to address a major public health issue where prevalence is high in given groups, its impact is multidimensional and treatment options are limited. The holistic treatment of chronic pain, including its neurobiological, cognitive, behavioral and psychological components, may become a valuable aid in the completion of the research project, with the ultimate aim of the study being the establishment of non-invasive stimulation of the vagus nerve for the treatment of chronic pain in clinical practice in the future.
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
Frequently Asked Questions
Who can join the NCT06912334 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 79 Years, studying Transcutaneous Vagus Nerve Stimulation on Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06912334 currently recruiting?
Yes, NCT06912334 is actively recruiting participants. Visit ClinicalTrials.gov or contact National and Kapodistrian University of Athens to inquire about joining.
Where is the NCT06912334 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT06912334 clinical trial?
NCT06912334 is sponsored by National and Kapodistrian University of Athens. The trial plans to enroll 120 participants.
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