FibromyalgiaNCT06009159
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
A study testing Transcutaneous Vagus Nerve Stimulation in people with Fibromyalgia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation
- 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
- 1 Jul 2024to 31 Oct 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 to 80 years old, including both male and female subjects.
- Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
- Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
Who cannot join
- Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
- Subject has major psychiatric disorder required hospitalization in the last 3 months.
- Subject has active infection at the site of device application.
- Subject has recurrent syncope symptoms within the past three months.
- Subject is pregnant.
- Subject has had VNS treatment within the past two months.
- .
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, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lucy Chen, M.D., 617-724-6102, llchen@mgh.harvard.edu
Jianren Mao, M.D., 617-724-6102, jmao@mgh.harvard.edu
About this study
Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.
Read the detailed description
The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.
- Conditions
- Fibromyalgia
- Being tested
- Transcutaneous Vagus Nerve Stimulation
- Keywords
- Vagus nerve stimulation,, pain, fibromyalgia symptoms
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationDevice
30 minutes stimulation, twice per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation(tVNS) | Experimental | receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. Receives: Device: Transcutaneous Vagus Nerve Stimulation |
| Sham Control group | No intervention | receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A modified McGill Pain Questionnaire
Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
Measured: at 0,4, weeks of the study,
Secondary outcomes (6)
Multidimensional Fatigue Inventory
Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.
Measured: at 0,4,8 weeks of the study
Medical Outcomes Study Sleep Scale
sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
Measured: at 0,4,8 weeks of the study
Revised Fibromyalgia Impact Questionnaire
Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
Measured: at 0,4,8 weeks of the study
Medical Outcomes Study Questionnaire Short Form 36
Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.
Measured: at 0, 4, 8 weeks of the study
Blood inflammation marker
collect blood sample for cytokines level
Measured: at 0, 4, 8 weeks of the study
Assessment of gut microbiome changes through genomic phenotypic
collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome
Measured: at 0, 4, 8 weeks of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2024
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- 4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Chen, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009159
- Sponsor's protocol ID
- 2023P001211
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moisset X, Lanteri-Minet M, Fontaine D. Neurostimulation methods in the treatment of chronic pain. J Neural Transm (Vienna). 2020 Apr;127(4):673-686. doi: 10.1007/s00702-019-02092-y. Epub 2019 Oct 21.
PubMed 31637517Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14.
PubMed 26364692Maffei ME. Fibromyalgia: Recent Advances in Diagnosis, Classification, Pharmacotherapy and Alternative Remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877. doi: 10.3390/ijms21217877.
PubMed 33114203
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT06009159
- Acronym / sponsor ID
- 2023P001211
- Conditions
- Fibromyalgia
- Keywords
- Vagus nerve stimulation,, pain, fibromyalgia symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 24 Aug 2023 (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.
Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.
Detailed description
The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation(tVNS) | Experimental | Device: Transcutaneous Vagus Nerve Stimulationreceive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
| Sham Control group | No intervention | –receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is 18 to 80 years old, including both male and female subjects.
- Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
- Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
Key exclusion criteria (7 listed)
- Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
- Subject has major psychiatric disorder required hospitalization in the last 3 months.
- Subject has active infection at the site of device application.
- Subject has recurrent syncope symptoms within the past three months.
- Subject is pregnant.
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 |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation30 minutes stimulation, twice per day for 4 weeks | Device | Transcutaneous Vagus Nerve Stimulation(tVNS) |
Primary outcome
A modified McGill Pain Questionnaire
Time frame: at 0,4, weeks of the study,
Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
6 secondary outcomes
Multidimensional Fatigue Inventory
Time frame: at 0,4,8 weeks of the study
Medical Outcomes Study Sleep Scale
Time frame: at 0,4,8 weeks of the study
Revised Fibromyalgia Impact Questionnaire
Time frame: at 0,4,8 weeks of the study
Medical Outcomes Study Questionnaire Short Form 36
Time frame: at 0, 4, 8 weeks of the study
Blood inflammation marker
Time frame: at 0, 4, 8 weeks of the study
Assessment of gut microbiome changes through genomic phenotypic
Time frame: at 0, 4, 8 weeks of the study
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 14 Sep 2026.
- Results publication: PubMed 31637517Moisset X, Lanteri-Minet M, Fontaine D. Neurostimulation methods in the treatment of chronic pain. J Neural Transm (Vienna). 2020 Apr;127(4):673-686. doi: 10.1007/s00702-019-02092-y. Epub 2019 Oct 21.
- Results publication: PubMed 26364692Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14.
- Results publication: PubMed 33114203Maffei ME. Fibromyalgia: Recent Advances in Diagnosis, Classification, Pharmacotherapy and Alternative Remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877. doi: 10.3390/ijms21217877.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Vagus Nerve Stimulation 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 7 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: looking for participants now, as of the sponsor's last update on 14 Sep 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 Lucy Chen, M.D. (617-724-3466, llchen@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A modified McGill Pain Questionnaire (time frame: at 0,4, weeks of the study,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06009159, which also lists 3 linked publications.
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 14 Sep 2026.