taVNS Treatment for Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Auricular transcutaneous electrical nerve stimulation device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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taVNS, Pain, Neuromodulation, Fibromyalgia