taVNS Treatment for Fibromyalgia

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia
• Interventions: Device: Auricular transcutaneous electrical nerve stimulation device

• Registration Number: NCT04777500
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-02
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-03
• Study Start: 2026-01-03
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
taVNS Group 2	Auricular transcutaneous electrical nerve stimulation device	This group will receive taVNS for 4 weeks.
taVNS Group1	Auricular transcutaneous electrical nerve stimulation device	This group will receive taVNS for 4 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.
power of oscillations in the alpha, theta, and gamma frequencies (optional)	Baseline and week 4.	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.
Beck Depression Inventory-II (BDI-II)	Baseline and week 4.
Brief Quantitative Sensory Testing (QST)	Baseline and week 4.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States