taVNS for Fibromyalgia

Overseen By Maya Eshel, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Thyroid disease, Lupus, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a small device that sends safe electrical signals can reduce the pain of fibromyalgia, a condition characterized by widespread pain and tenderness. Participants will use this auricular transcutaneous electrical nerve stimulation device on their ears for four weeks to determine its effectiveness in easing symptoms. Individuals diagnosed with fibromyalgia who are willing to try a new treatment twice daily for a month may be suitable candidates. The study, conducted at Massachusetts General Hospital, aims to include 60 participants. As an unphased trial, it offers a unique opportunity for patients to explore innovative treatment options for fibromyalgia.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team for guidance.

What prior data suggests that this auricular transcutaneous electrical nerve stimulation device is safe for fibromyalgia?

Research has shown that using a device to gently stimulate a nerve in the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS), is safe and generally well-tolerated. One study found that taVNS did not cause serious side effects and could be used in medical settings. Another review confirmed it as a safe and acceptable treatment.

These findings suggest that taVNS is generally safe for people and might help manage fibromyalgia pain. However, as with any treatment, individual experiences can vary. Consulting with a healthcare provider before starting a new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular transcutaneous electrical nerve stimulation (taVNS) for fibromyalgia because it offers a non-drug approach to managing this chronic pain condition. Unlike traditional treatments such as medications, physical therapy, or lifestyle changes that often take time to show effects, taVNS uses a device that stimulates the nerves in the ear to potentially provide quicker relief. This technique taps into the body's natural nerve pathways, potentially reducing pain and improving quality of life without the side effects commonly associated with medications. By targeting the nervous system directly, taVNS could offer a novel and promising alternative for fibromyalgia patients seeking faster and more effective pain management solutions.

What evidence suggests that this device is effective for Fibromyalgia?

Research has shown that auricular transcutaneous electrical nerve stimulation (taVNS) might help reduce pain in people with fibromyalgia. One study found that 29.4% of patients using taVNS experienced a pain reduction of more than half when treated at a low frequency of 1 Hz. Another study demonstrated that taVNS can improve heart rate variability, indicating better stress management by the body. In this trial, participants will be divided into two groups, each receiving taVNS for 4 weeks. These findings suggest that taVNS could be a promising way to manage fibromyalgia pain by affecting the nervous system. ^{1 4 5 6 7}

Who Is on the Research Team?

Jian Kong

Principal Investigator

MGH

Are You a Good Fit for This Trial?

This trial is for individuals who meet the American College of Rheumatology's criteria for Fibromyalgia, are willing to undergo a 4-week treatment twice daily, and have at least a 10th grade English-reading level. It's not specified who can't join.

Inclusion Criteria

Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.

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.

I am willing to undergo a 4-week treatment twice a day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) for 4 weeks

4 weeks

Baseline, week 2, and week 4 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auricular transcutaneous electrical nerve stimulation device

Trial Overview The study is testing if taVNS (auricular transcutaneous electrical nerve stimulation), which is a safe electrical stimulation device, can help relieve pain in people with Fibromyalgia. The trial will enroll 60 subjects at Massachusetts General Hospital.

How Is the Trial Designed?

Group I: taVNS Group1 Experimental Treatment 1 Intervention

This group will receive taVNS for 4 weeks.

Group II: taVNS Group 2 Experimental Treatment 1 Intervention

This group will receive taVNS for 4 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10914987/

Evaluating the efficacy and acceptability of vagus nerve ... This protocol of a systematic review and meta-analysis aims to synthesize the existing evidence to clarify the efficacy and acceptability of VNS for treating ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1297319X25001289

Non-invasive auricular vagus nerve stimulation in ... Notably, tVNS has demonstrated beneficial effects on heart rate variability (HRV), a reliable index of autonomic nervous system function that is frequently ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7071794/

The Impact of Auricular Vagus Nerve Stimulation on Pain and ... Overall, 29.4% of the patients in the 1 Hz. group experienced a reduction greater than 50% while patients in the 25 Hz. group experienced a reduction of 13.3%.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06912334

Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- ... However, the effects of multiple sessions of transcutaneous vagus nerve stimulation (tVNS) in fibromyalgia have not been evaluated in randomized clinical trials ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07173400

Effects of Transcutaneous Auricular Vagus Nerve ... The investigators will assess outcomes including pain intensity, sleep quality, central sensitization, and fear of movement (kinesiophobia). Detailed ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04777500

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772204/

Safety of transcutaneous auricular vagus nerve stimulation ... This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...