taVNS Treatment for Fibromyalgia

Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Auricular transcutaneous electrical nerve stimulation device

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Eshel, BA; Phone Number: (617) 726-5004; Email: meshel@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129-2020
      • Massachusetts General Hospital
      • Contact: Maya Eshel; Email: meshel@mgh.harvard.edu
      • Contact: Rachel Dao; Email: rdao@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS Group1; This group will receive taVNS for 4 weeks.	Device: Auricular transcutaneous electrical nerve stimulation device; We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
Experimental: taVNS Group 2; This group will receive taVNS for 4 weeks.	Device: Auricular transcutaneous electrical nerve stimulation device; We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Fibromyalgia Impact Questionnaire (FIQR)	A change in the FIQR would indicate that participants are experiencing pain relief.	Baseline, week 2 and week 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS-29)		Baseline, week 2 and week 4.
Pain Catastrophizing Scale		Baseline, week 2 and week 4.
Beck Depression Inventory-II (BDI-II)		Baseline and week 4.
Brief Quantitative Sensory Testing (QST)		Baseline and week 4.
Heart rate variability		Baseline and week 4.
power of oscillations in the alpha, theta, and gamma frequencies (optional)	6 minutes of resting state EEG (with eyes open) (Optional). We will calculate the power of oscillations in the alpha, theta, and gamma frequencies, which will be normalized by the mean power for the global spectrum.	Baseline and week 4.
Blood inflammation markers (optional)	We will examine inflammatory mediators such as interleukins (ILs including IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, and IL-10), IFN-γ, and tumor necrosis factor (TNF) via multiplex immunoassays using Luminex, as well as highly sensitive C-reactive protein (hsCRP), programmed death 1 (PD-1), prostaglandin E2, and BDNF.	Baseline and week 4

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jian Kong, MGH

Study record dates

Study Major Dates

• Study Start (Estimated): October 3, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Neuromodulation; Fibromyalgia; taVNS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Fibromyalgia
• Other Study ID Numbers: 2020P003800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes