Vagus Nerve Stimulation for Fibromyalgia

Overseen By Elly Pichardo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Uncontrolled diabetes, Heart failure, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain in people with fibromyalgia using a device that stimulates the ear. The device, called transauricular vagus nerve stimulation (taVNS), is non-invasive and may alter how the brain processes pain. Participants are divided into two groups: one receives the actual stimulation, and the other receives a sham (fake) version for comparison. The trial seeks individuals who have experienced fibromyalgia pain for over six months and can feel touch on their forearm. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques for fibromyalgia.

Do I need to stop 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 trial coordinators.

What prior data suggests that this device is safe for fibromyalgia?

Research shows that transauricular vagus nerve stimulation (taVNS) is generally safe and well-tolerated. This method involves placing small electrodes on the ear and has not been linked to serious side effects. Most people experience only minor discomfort, if any, during the treatment.

Some studies suggest that taVNS can alter pain perception, potentially benefiting conditions like fibromyalgia. In these studies, taVNS changed pain perception without causing significant negative effects. The procedure is non-invasive, meaning it doesn't involve surgery, which reduces the risk of complications. Overall, evidence supports the safety of taVNS in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard fibromyalgia treatments, which often involve medications like pain relievers, antidepressants, or anti-seizure drugs, transauricular vagus nerve stimulation (taVNS) offers a non-drug approach to managing symptoms. This method is unique because it uses gentle electrical impulses delivered through the ear to stimulate the vagus nerve, which plays a role in regulating pain and inflammation. Researchers are excited about taVNS because it targets the nervous system directly, potentially providing relief without the side effects associated with traditional medications. Additionally, this technique allows for adjustable intensity, offering a personalized treatment experience.

What evidence suggests that transauricular vagus nerve stimulation (taVNS) is effective for fibromyalgia?

Research has shown that transauricular vagus nerve stimulation (taVNS) can help manage pain, including in conditions like fibromyalgia. One study found that taVNS improved pain management and quality of life for people with fibromyalgia. This trial will compare active taVNS, which uses small devices placed on the ear to alter how the brain processes pain, with a sham taVNS condition where the device is turned off. Another study supported the effectiveness and safety of this treatment for both long-term and short-term pain. Overall, these findings suggest taVNS could be a promising option for those seeking relief from fibromyalgia pain. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with fibromyalgia, a condition characterized by widespread musculoskeletal pain. Participants should be diagnosed with fibromyalgia or myofascial pain syndrome to qualify.

Inclusion Criteria

Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)

Must have the ability to feel sensation by Von-Frey fiber on the forearm

Able to provide informed consent to participate in the study

Exclusion Criteria

I am not pregnant and agree to regular pregnancy tests if of child-bearing age.

History of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria)

Presence of implanted cranial electronic medical devices (e.g., cochlear implants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham taVNS for 60 minutes per session, across 16 sessions

4 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transauricular vagus nerve stimulation (taVNS)

Trial Overview The study is testing the effects of transauricular vagus nerve stimulation (taVNS), which involves a non-invasive device placed on the ear to potentially alleviate pain in fibromyalgia patients.

How Is the Trial Designed?

Group I: Active taVNS Experimental Treatment 1 Intervention

TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hertz (Hz), 200-250 us, and with adjustable intensity for 60 min for 16 sessions.

Group II: Sham taVNS Placebo Group 1 Intervention

Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min for 16 sessions there will be no current and the device will be turned off.

Transauricular vagus nerve stimulation (taVNS) is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Refractory Depression
• Chronic Obesity

Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression
• Tinnitus
• Post-stroke upper limb function

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Published Research Related to This Trial

Fibromyalgia (FM) is linked to dysfunction in neurotransmitter systems and low vagal tone, which may contribute to symptoms like chronic pain and fatigue, suggesting a biological basis for the condition.

The vagus nerve (VN) has anti-inflammatory properties and is associated with emotional regulation, indicating that targeting VN function could offer new therapeutic strategies for managing FM symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the vagus nerve in fibromyalgia syndrome. Martins, DF., Viseux, FJF., Salm, DC., et al.[2022]

Transcutaneous auricular Vagal Nerve Stimulation (taVNS) did not show any significant effects on pain perception or nociception in healthy participants, as measured by event-related potentials and sensory testing across three experiments involving 22 and 15 subjects.

Both taVNS and standard cervical VNS (cVNS) failed to produce objective changes in behavioral and cerebral responses to pain stimuli, suggesting that the analgesic effects of taVNS may not be as effective as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. Dumoulin, M., Liberati, G., Mouraux, A., et al.[2021]

This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.

The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., et al.[2023]

In a Phase I/II trial involving 14 patients with treatment-resistant fibromyalgia, vagus nerve stimulation (VNS) was found to be generally safe and tolerable, with side effects similar to those seen in epilepsy and depression treatments, including dry mouth and fatigue.

After 3 months of VNS, 5 out of 12 patients showed significant improvement in pain and overall wellness, with some patients even losing their fibromyalgia diagnosis criteria, suggesting VNS could be a promising adjunct treatment for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. Lange, G., Janal, MN., Maniker, A., et al.[2021]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.

The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11309651/

Transcutaneous vagus nerve stimulation effects on chronic pain The impact of auricular vagus nerve stimulation on pain and life quality in patients with fibromyalgia syndrome. Biomed Res Int 2020;2020 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06193317

NCT06193317 | Effects of taVNS on Fibromyalgia Pain Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11543973/

Clinical Efficacy of Auricular Vagus Nerve Stimulation in the ... The aim of this systematic review and meta-analysis is to evaluate the clinical efficacy and safety of aVNS in treating chronic and acute pain conditions.

4. nature.com nature.com/articles/s41598-025-17821-5

The effects of non-invasive transcutaneous auricular vagus ... Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising technique that potentially influences cortical activity, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07198737

Effect of Virtual Reality and Trans Auricular X-Vagus Nerve ... This study aims to evaluate the feasibility and safety, of a trial of taVNS paired with VR looking at trial recruitment, retention and ...

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

Evaluating the efficacy and acceptability of vagus nerve ... The impact of auricular Vagus nerve stimulation on pain and life quality in patients with fibromyalgia syndrome. Biomed Res Int. (2020) 2020 ...

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

Non-invasive auricular vagus nerve stimulation in ... This pilot study suggests that tVNS may be a safe, well-tolerated, and effective intervention for modulating autonomic and central mechanisms in fibromyalgia.