FibromyalgiaNCT04777500
taVNS Treatment for Fibromyalgia
A study testing Auricular transcutaneous electrical nerve stimulation device in people with Fibromyalgia, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Auricular transcutaneous electrical nerve stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129-2020
Maya Eshel, meshel@mgh.harvard.edu
Rachel Dao, rdao@mgh.harvard.edu
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Auricular transcutaneous electrical nerve stimulation device
- Keywords
- taVNS, Pain, Neuromodulation, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular transcutaneous electrical nerve stimulation deviceDevice
We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Group1 | Experimental | This group will receive taVNS for 4 weeks. Receives: Device: Auricular transcutaneous electrical nerve stimulation device |
| taVNS Group 2 | Experimental | This group will receive taVNS for 4 weeks. Receives: Device: Auricular transcutaneous electrical nerve stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Fibromyalgia Impact Questionnaire (FIQR)
A change in the FIQR would indicate that participants are experiencing pain relief.
Measured: Baseline, week 2 and week 4.
Secondary outcomes (7)
Patient Reported Outcomes Measurement Information System (PROMIS-29)
Measured: Baseline, week 2 and week 4.
Pain Catastrophizing Scale
Measured: Baseline, week 2 and week 4.
Beck Depression Inventory-II (BDI-II)
Measured: Baseline and week 4.
Brief Quantitative Sensory Testing (QST)
Measured: Baseline and week 4.
Heart rate variability
Measured: 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.
Measured: 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.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start3 Oct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
- Investigators
- Jian Kong, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777500
- Sponsor's protocol ID
- 2020P003800
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia
- ClinicalTrials.gov ID
- NCT04777500
- Acronym / sponsor ID
- 2020P003800
- Conditions
- Fibromyalgia
- Keywords
- taVNS, Pain, Neuromodulation, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS Group1 | Experimental | Device: Auricular transcutaneous electrical nerve stimulation deviceThis group will receive taVNS for 4 weeks. |
| taVNS Group 2 | Experimental | Device: Auricular transcutaneous electrical nerve stimulation deviceThis group will receive taVNS for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular transcutaneous electrical nerve stimulation deviceWe are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia. | Device | taVNS Group 2, taVNS Group1 |
Primary outcome
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.
7 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Baseline, week 2 and week 4.
Pain Catastrophizing Scale
Time frame: Baseline, week 2 and week 4.
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline and week 4.
Brief Quantitative Sensory Testing (QST)
Time frame: Baseline and week 4.
Heart rate variability
Time frame: Baseline and week 4.
power of oscillations in the alpha, theta, and gamma frequencies (optional)
Time frame: Baseline and week 4.
Blood inflammation markers (optional)
Time frame: Baseline and week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Kong principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular transcutaneous electrical nerve stimulation device in people with Fibromyalgia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Eshel, BA ((617) 726-5004, meshel@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Fibromyalgia Impact Questionnaire (FIQR) (time frame: Baseline, week 2 and week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.