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NCT Number: NCT04777500

taVNS Treatment for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular transcutaneous electrical nerve stimulation device

Device

We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

Primary outcomes

  1. 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

  1. Patient Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Baseline, week 2 and week 4.

  2. Pain Catastrophizing Scale

    Time frame: Baseline, week 2 and week 4.

  3. Beck Depression Inventory-II (BDI-II)

    Time frame: Baseline and week 4.

  4. Brief Quantitative Sensory Testing (QST)

    Time frame: Baseline and week 4.

  5. Heart rate variability

    Time frame: Baseline and week 4.

  6. power of oscillations in the alpha, theta, and gamma frequencies (optional)

    Time frame: 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.

  7. Blood inflammation markers (optional)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Eshel, BA

CONTACT

[email protected]

(617) 726-5004

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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