Auricular Neuromodulation for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Overseen by Anna Woodbury, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Seizures, Claustrophobia, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

PENFS (percutaneous electrical nerve field stimulation) is an FDA-cleared acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal. PENFS has been previously shown to provide improvements in fibromyalgia, a difficult to treat chronic pain syndrome, which correlate with changes observed using a special kind of MRI called resting state functional connectivity MRI (rs-fcMRI) that evaluates brain activity at rest. The goals of this study are to rigorously test the initial promising results of PENFS in a much larger group of Veterans suffering from fibromyalgia and to identify potential mechanisms of PENFS effects. Further developing non-pharmacologic therapies for pain can help to improve quality of life and function for those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have numerous side effects for individuals suffering from chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on testing a non-drug therapy, so it's best to ask the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Percutaneous electrical nerve field stimulation (PENFS) for fibromyalgia?

Research shows that auricular percutaneous electrical nerve field stimulation (PENFS) can change brain structures and chemicals in veterans with fibromyalgia, suggesting it might help manage symptoms. Additionally, similar treatments like non-invasive neuro-adaptive electrostimulation have been shown to reduce pain and disability in fibromyalgia patients.

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Is auricular neuromodulation safe for humans?

The research does not provide specific safety data for auricular neuromodulation, but it mentions that current therapies for fibromyalgia often come with significant risks, suggesting a need for safer alternatives like non-invasive treatments.

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How is the treatment Auricular Neuromodulation for Fibromyalgia different from other treatments?

Auricular Neuromodulation for Fibromyalgia uses a unique approach called percutaneous electrical nerve field stimulation (PENFS), which involves applying electrical stimulation to the ear to influence brain activity and reduce pain. This method is different from traditional treatments as it targets nerve pathways directly and is non-invasive, potentially altering brain structures associated with pain perception.

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Eligibility Criteria

This trial is for veterans with fibromyalgia, a chronic pain condition. Participants should have symptoms that match the criteria for myofascial pain syndrome or fibromyalgia. Specific eligibility details are not provided but typically include factors like age, overall health, and severity of symptoms.

Inclusion Criteria

My skin is healthy where the PENFS treatment will be applied.

I can safely undergo an MRI.

Right-handedness, to provide consistency in brain structure and function

Exclusion Criteria

Claustrophobia

MRI-incompatible implants, or other conditions incompatible with MRI (only for those who elect to perform MRI)

History of uncontrolled psychiatric illness

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either true or sham auricular PENFS, with the device applied weekly for 4 weeks

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 week, 12 weeks, and 24 weeks post-treatment

24 weeks

3 visits (in-person)

Open-label extension (optional)

Participants initially assigned to sham placebo PENFS and not identified as placebo-responders may opt to test the true PENFS device

Participant Groups

The study tests PENFS (percutaneous electrical nerve field stimulation), an FDA-approved therapy similar to acupuncture but on the ear. It aims to improve pain and physical function by stimulating nerves. The effectiveness will be measured using MRI scans that assess brain activity at rest.

Group I: True PENFS Active Control 1 Intervention

Percutaneous electrical nerve stimulation applied to the ear x 4 over a 4 week period. The device is placed over the area of the ear and worn home continuously for a 5-day period, during which time it stimulates at a pre-set on/off duty cycle. At each in-person visit, the device is replaced until the device has been placed 4 times. The stimulation delivered is below the threshold of sensory perception.

Group II: Sham PENFS Placebo Group 1 Intervention

A device is placed at the same points for the same amount of time and at the same intervals as the true device. This device will not deliver electrical stimulation.

Percutaneous electrical nerve field stimulation is already approved in United States for the following indications:

🇺🇸 Approved in United States as IB-Stim for:

• Functional abdominal pain associated with irritable bowel syndrome (IBS) in patients 11-18 years of age

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Atlanta VA Medical and Rehab Center, Decatur, GA Decatur, GA

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. [2023] To evaluate the feasibility of recruitment, preliminary efficacy, and acceptability of auricular percutaneous electrical nerve field stimulation (PENFS) for the treatment of fibromyalgia in veterans, using neuroimaging as an outcome measure and a biomarker of treatment response.

2. United States pubmed.ncbi.nlm.nih.gov

Effects of neuro-adaptive electrostimulation therapy on pain and disability in fibromyalgia: A prospective, randomized, double-blind study. [2021] To evaluate the effectiveness of non-invasive neuro-adaptive electrostimulation (NAE) therapy for treating chronic pain and disability in patients with fibromyalgia.

3. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. [2011] To evaluate the clinical outcomes of 100 consecutive patients receiving peripheral nerve field stimulation (PNFS) for the treatment of chronic intractable pain.

4. United States pubmed.ncbi.nlm.nih.gov

Percutaneous electric nerve field stimulation alters cortical thickness in a pilot study of veterans with fibromyalgia. [2023] To evaluate changes in cortical thickness and right posterior insula (r-pIns) gamma-aminobutyric acid (GABA) concentrations in veterans with fibromyalgia treated with auricular percutaneous electric nerve field stimulation (PENFS).

5. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. [2015] To evaluate long-term outcomes of a noninvasive cortical stimulation technology in the treatment of fibromyalgia (FM).

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. [2021] We performed an open-label Phase I/II trial to evaluate the safety and tolerability of vagus nerve stimulation (VNS) in patients with treatment-resistant fibromyalgia (FM) as well as to determine preliminary measures of efficacy in these patients.

7. Canada pubmed.ncbi.nlm.nih.gov

Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. [2021] Fibromyalgia is a chronic pain state that includes widespread musculoskeletal pain, fatigue, psychiatric symptoms, cognitive and sleep disturbances, and multiple somatic symptoms. Current therapies are often insufficient or come with significant risks, and while there is an increasing demand for non-pharmacologic and especially non-opioid pain management such as that offered through complementary and alternative medicine therapies, there is currently insufficient evidence to recommend these therapies. Percutaneous electrical neural stimulation (PENS) is an evidence-based treatment option for pain conditions that involves electrical current stimulation through needles inserted into the skin. Percutaneous electrical neural field stimulation (PENFS) of the auricle is similar to PENS, but instead of targeting a single neurovascular bundle, PENFS stimulates the entire ear, covering all auricular branches of the cranial nerves, including the vagus nerve. The neural mechanisms of PENFS for fibromyalgia symptom relief are unknown.

8. Switzerland pubmed.ncbi.nlm.nih.gov

High-Frequency Peripheral Nerve Stimulation for Craniofacial Pain. [2021] Since the first successful use of high-frequency electrical stimulation of trigeminal branches for treatment of facial pain in 1962, neuromodulation techniques become well established but remain greatly underutilised. Most subsequent implantation techniques and commercial devices for peripheral nerve stimulation, available until the last decade, utilised frequencies in the range 1-100 Hz. With the commercial introduction of 10-kHz spinal cord stimulation, there has been renewed interest in peripheral applications of kHz frequency neuromodulation. High-frequency biphasic stimulation causes rapid onset, reversible conduction block in mammalian nerves which might be useful in human peripheral neuromodulation applications, but the conduction block induced at kilohertz frequencies may not be the only mechanism contributing to analgesia. We discuss likely mechanisms of action of high-frequency peripheral nerve stimulation and present several clinical examples of successful use of this modality in various facial pain conditions. A change to sub-threshold higher frequencies in the 10 kHz range adds a number of distinct advantages. The lack of paresthesias is welcomed by patients. The ability to place the stimulating electrode approximately 1 cm away from the targeted nerve has an anatomical and surgical advantage.