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Transcutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS)

RecruitingNAAges 18 Years - 70 YearsFemaleUniversity of Roma La Sapienza
NCT07682090 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Moreover, approximately 50% of patients with FMS show reduced intraepidermal small fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP), which has recently been suggested to contribute to autonomic dysfunction in these patients. Despite currently available pharmacological and non-pharmacological treatments, therapeutic efficacy remains limited, highlighting the need for novel mecha

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transcutaneous Vagus Nerve Stimulation
  • Sham Transcutaneous Vagus Nerve Stimulation
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Where

1 site
Department of Human Neuroscience
Rome, Italy
🤝 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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