Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia

Massachusetts General Hospital1 site in 1 country60 target enrollmentOctober 3, 2026

ConditionsFibromyalgia

InterventionsAuricular transcutaneous electrical nerve stimulation device

Overview

Phase: Not Applicable
Intervention: Auricular transcutaneous electrical nerve stimulation device
Conditions: Fibromyalgia
Sponsor: Massachusetts General Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Revised Fibromyalgia Impact Questionnaire (FIQR)
Status: Not yet recruiting
Last Updated: 15 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.

Registry

clinicaltrials.gov

Start Date

October 3, 2026

End Date

March 1, 2027

Last Updated

15 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Jian Kong

Principle investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
•Willingness to complete a 4-week, twice-a-day treatments.
•At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Exclusion Criteria

•Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.
•History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
•Personal history of medical or psychiatric illness as determined by investigator.
•Pregnant or lactating.
•Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Arms & Interventions

taVNS Group1

This group will receive taVNS for 4 weeks.

Intervention: Auricular transcutaneous electrical nerve stimulation device

taVNS Group 2

This group will receive taVNS for 4 weeks.

Intervention: Auricular transcutaneous electrical nerve stimulation device

Outcomes

Primary Outcomes

Revised Fibromyalgia Impact Questionnaire (FIQR)

Time Frame: Baseline, week 2 and week 4.

A change in the FIQR would indicate that participants are experiencing pain relief.

Secondary Outcomes

Patient Reported Outcomes Measurement Information System (PROMIS-29)(Baseline, week 2 and week 4.)
Heart rate variability(Baseline and week 4.)
Pain Catastrophizing Scale(Baseline, week 2 and week 4.)
Blood inflammation markers (optional)(Baseline and week 4)
power of oscillations in the alpha, theta, and gamma frequencies (optional)(Baseline and week 4.)
Beck Depression Inventory-II (BDI-II)(Baseline and week 4.)
Brief Quantitative Sensory Testing (QST)(Baseline and week 4.)