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Device

Vagus Nerve Stimulation for Fibromyalgia

N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
Subject is 18 to 70 years old, including both male and female subjects.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 4, 8 weeks of the study
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate whether stimulating the vagus nerve can help improve pain and other symptoms in patients with fibromyalgia. Current treatments for fibromyalgia are not very effective, so researchers

Who is the study for?
This trial is for individuals aged 18 to 70 who have been diagnosed with Fibromyalgia (FM) for at least three months and are experiencing a pain score of 4 or higher. It's open to both men and women.
What is being tested?
The study is testing Transcutaneous Vagus Nerve Stimulation (VNS) as a potential treatment for FM, aiming to see if it can improve pain and related symptoms by stimulating the vagus nerve non-invasively.
What are the potential side effects?
While specific side effects of Transcutaneous VNS in this trial aren't listed, common ones may include headache, neck pain, voice changes, tingling or prickling skin sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain level is 4 or higher on a scale of 0 to 10.
Select...
I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0,4,8 weeks of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0,4,8 weeks of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
A modified McGill Pain Questionnaire
Secondary study objectives
Assessment of gut microbiome changes through genomic phenotypic
Blood inflammation marker
Medical Outcomes Study Questionnaire Short Form 36
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transcutaneous Vagus Nerve Stimulation(tVNS)Experimental Treatment1 Intervention
receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
Group II: Sham Control groupActive Control1 Intervention
receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Vagus Nerve Stimulation
2023
N/A
~230

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,760 Total Patients Enrolled
~40 spots leftby Dec 2025
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