taVNS Treatment for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777500
• Other study ID #: 2020P003800
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: March 2023

Study information

• Verified date: August 2021
• Source: Massachusetts General Hospital
• Contact: Maya Eshel, BA
• Phone: (617) 726-5004
• Email: meshel[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Auricular transcutaneous electrical nerve stimulation device
We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Reported Outcomes Measurement Information System (PROMIS-29)		Baseline, week 2 and week 4.
Secondary	Pain Catastrophizing Scale		Baseline, week 2 and week 4.
Secondary	Beck Depression Inventory-II (BDI-II)		Baseline and week 4.
Secondary	Brief Quantitative Sensory Testing (QST)		Baseline and week 4.
Secondary	Heart rate variability		Baseline and week 4.
Secondary	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.
Secondary	Blood inflammation markers (optional)	We will examine inflammatory mediators such as interleukins (ILs including IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, and IL-10), IFN-?, 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