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New treatment option for Fibromyalgia Syndrome
Official title Transcutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS)
ClinicalTrials.gov ID: NCT07682090
What this study is testing
- What it's testing
- Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain, fatigue, sleep disturbances, cognitive symptoms, and autonomic dysfunction, significantly impairing quality of life. Increasing evidence suggests that, beyond central pain dysregulation, patients with FMS frequently exhibit autonomic nervous system dysfunction, characterized by sympathetic nervous system (SNS) hyperactivity at rest, with reduced SNS recruitment during orthostatic challenge.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Lazio, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.