Using Vagus Nerve Stimulation to Treat Fibromyalgia
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
This study is testing whether a new treatment using vagus nerve stimulation can help people with fibromyalgia feel less pain and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06009159 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on patients with fibromyalgia, a condition characterized by widespread pain and other symptoms. The trial will involve 60 participants who will be randomly assigned to either a tVNS group or a control group for a duration of four weeks. The primary focus will be on measuring pain intensity, while secondary outcomes will include fatigue, sleep quality, and overall health-related quality of life. The goal is to gather preliminary data on the efficacy of this non-invasive treatment method for managing fibromyalgia symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a documented diagnosis of fibromyalgia and a pain score of 4 or above.
Not a fit: Patients with cardiac arrhythmias, major psychiatric disorders, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing pain and other symptoms associated with fibromyalgia.
How similar studies have performed: While the use of vagus nerve stimulation is a novel approach for fibromyalgia, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 active infection at the site of device application. 4. Subject has recurrent syncope symptoms within the past three months. 5. Subject is pregnant. 6. Subject has had VNS treatment within the past two months. .
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Lucy Chen, M.D.
- Email: llchen@mgh.harvard.edu
- Phone: 617-724-3466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.