Massachusetts General Hospital
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.
Fibromyalgia is a chronic condition that can cause widespread pain, fatigue, sleep problems, anxiety, and depression. While current treatments can help manage symptoms, many people continue to experience significant discomfort and reduced quality of life. This study will evaluate whether transcutaneous vagus nerve stimulation (tVNS), a non-invasive therapy that delivers mild electrical stimulation to the outer ear, can help reduce pain and other symptoms in people with fibromyalgia. The vagus nerve helps regulate communication between the brain and the body and may play a role in pain process…
Inclusion Criteria: 1. Subject is 18 to 80 years old, including both male and female subjects. 2. 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. 3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain). Exclusion Criteria: 1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device. 2. Subject has major psychiatric disorder required hospitalization in the last 3 months. 3. Subject has act…
30 minutes stimulation, twice per day for 6 weeks
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.