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Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation

A legfontosabb adatok

Hol
Boston (Egyesült Államok)A helyszín megnézése

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Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 80 év között vagy?

Forrás: NCT07904351: ki vehet részt

Helyszínek itt: Egyesült Államok

  • Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Melissa Difuntorum, B.S.No longer taking part

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Contact the study team: see the registry record → Contacts and Locations

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A vizsgálat adatai

Ki végzi
Massachusetts General Hospital
Azonosító
NCT07904351
A regiszteradat frissítve
2026. november 2.
Eredeti leírás
Fibromyalgia is a syndrome with clinical symptoms that affect multiple systems of the body. Although basic science research and clinical research trials have been carried out, the cause and the mechanism of fibromyalgia are still unknown. The goal of current medical treatment is to relieve symptoms and improve quality of life. Recent clinical and experimental studies have shown that stimulation of the vagus nerve has a potential to help pain syndromes. In this study, we aim to evaluate the effects of using transcutaneous vagus nerve stimulation (tVNS) on treating pain and other symptoms in fibromyalgia patients. We will do this by using the VagaCalm device.A teljes eredeti leírásKevesebb

Fibromyalgia is a syndrome with clinical symptoms that affect multiple systems of the body. Although basic science research and clinical research trials have been carried out, the cause and the mechanism of fibromyalgia are still unknown. The goal of current medical treatment is to relieve symptoms and improve quality of life. Recent clinical and experimental studies have shown that stimulation of the vagus nerve has a potential to help pain syndromes. In this study, we aim to evaluate the effects of using transcutaneous vagus nerve stimulation (tVNS) on treating pain and other symptoms in fibromyalgia patients. We will do this by using the VagaCalm device.

Bevonási feltételek: Subject is 18 to 80 years old, including both male and female subjects; Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation; Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).

Kizáró feltételek: Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device; Subject has major psychiatric disorder required hospitalization in the last 3 months; Subject has active infection at the site of device application; Subject has recurrent syncope symptoms within the past three months; Subject is pregnant; Subject has had VNS treatment within the past two months.

ClinicalTrials.gov NCT07904351