Evaluating Transcutaneous Vagus Nerve Stimulation to Relieve Pain and Autonomic Symptoms in Women with Fibromyalgia Syndrome

What this Trial Is About

Fibromyalgia syndrome FMS is a chronic pain disorder marked by widespread pain, fatigue, sleep problems, cognitive issues, mood changes, and autonomic dysfunction, which greatly affect daily life quality. This trial studies the effects of transcutaneous vagus nerve stimulation tVNS, a non-invasive device-based therapy, aiming to improve symptoms by enhancing parasympathetic nervous system activity. The study is randomized, sham-controlled, and double-blind, focusing on women diagnosed with FMS. Participants will be randomly assigned to receive either active tVNS or sham stimulation daily for 30 minutes over four weeks using the Nurosym device applied to the ears tragus. The active group receives stimulation designed to modulate pain and autonomic pathways, while the sham group undergoes a similar procedure without therapeutic stimulation. Both groups adjust stimulation intensity individually to produce a mild tingling sensation. Throughout the study, participants will complete questionnaires measuring fibromyalgia severity, autonomic symptoms, fatigue, sleep quality, and pain at baseline, during treatment, end of treatment, and follow-up. Tests such as heart rate variability analysis, sweat tests, skin biopsies, and blood biomarker assessments will evaluate autonomic function and biological changes. Researchers aim to identify responders and understand how tVNS affects symptoms, with total participation lasting at least eight weeks to include follow-up assessments.

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