Vagus Nerve Stimulation for Chronic Pain

Overseen By Rachael Wlton-Mouw, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Georgia

Disqualifiers: Cardiovascular, Neurological, Endocrine, Gastrointestinal, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how vagus nerve stimulation (VNS) can reduce chronic, widespread pain. It compares two methods: electrical ear stimulation and deep exhalation breathing, to determine which better improves pain, emotional well-being, and quality of life. Participants will be divided into three groups, with some trying one of the VNS methods and others not receiving any treatment initially. Suitable candidates are adults diagnosed by a healthcare provider with chronic widespread pain or fibromyalgia. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance quality of life.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that vagus nerve stimulation is safe for chronic pain management?

Research has shown that stimulating the vagus nerve is generally safe. Studies have used this method for conditions like epilepsy and depression, and it is usually well-tolerated. Non-invasive techniques, such as electrical stimulation on the ear, have been reported as safe and practical. A review found that this ear method, known as transcutaneous auricular VNS, is a safe and promising option for medical use.

For the deep exhalation method, direct safety data is limited, but its non-invasive nature likely carries minimal risk. Overall, while minor side effects may occur, these methods are considered safe for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vagus nerve stimulation techniques being explored for chronic pain because they offer non-invasive and innovative approaches that differ from traditional pain management methods, such as medications and surgeries. One unique feature is the use of deep exhalation exercises to naturally stimulate the vagus nerve, potentially reducing pain without any surgical procedures or pharmaceuticals. Another method involves applying low-frequency electrical stimulation to the ear, which is a novel delivery system that directly targets the nerve pathways involved in pain modulation. These techniques could provide safer, side-effect-free alternatives for patients seeking relief from chronic pain.

What evidence suggests that vagus nerve stimulation might be an effective treatment for chronic pain?

This trial will compare different methods of vagus nerve stimulation for chronic pain. Studies have shown that stimulating the vagus nerve can reduce pain, particularly for headaches and migraines. In this trial, one group will perform vagal nerve stimulation through deep exhalation exercises, which research suggests can calm the nervous system and potentially lower pain levels. Another group will receive vagal nerve stimulation through gentle electrical pulses on the ear, a method found to help with both long-term and short-term pain by reducing swelling and boosting overall health. Both methods are safe, non-invasive, and have effectively managed chronic pain. Overall, vagus nerve stimulation shows promise for improving pain relief and quality of life. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with chronic, widespread pain such as fibromyalgia. Participants should be willing to undergo daily exercises or wear a non-invasive ear device for two weeks and attend two in-person sessions. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with chronic widespread pain or fibromyalgia.

Exclusion Criteria

History of concussion or traumatic brain injury

Skin sensitivity to electrical stimulation: allergic reaction, rash, or irritation from electrode pads or electrical devices applied to the skin

I do not have uncontrolled diabetes, thyroid, or adrenal disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of three groups: Electrical Ear Stimulation, Deep Exhalation Breathing, or Control Group. The treatment lasts for 2 weeks.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, muscle stiffness, and quality of life.

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vagus Nerve Stimulation

Trial Overview The study tests the effectiveness of vagus nerve stimulation (VNS) via electrical ear stimulation or deep exhalation breathing exercises against no treatment. It aims to determine which method better improves pain intensity, emotional well-being, and quality of life over a two-week period.

How Is the Trial Designed?

Group I: No intervention Experimental Treatment 1 Intervention

Participants in this group will not receive any treatment for vagal nerve stimulation.

Group II: Vagal Nerve Stimulation through deep exhalation. Active Control 1 Intervention

Vagal nerve stimulation will be performed through deep exhalation exercise, performed once every hour during the waking hours each day.

Group III: Vagal Nerve Stimulation through ear electrical stimulation Active Control 1 Intervention

Vagal nerve stimulation will be performed through applying low frequency electrical stimulation to the external ear lobe for 20 minutes twice a day.

Who Is Running the Clinical Trial?

University of North Georgia

Lead Sponsor

Trials

4

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07080749

The Effect of Vagus Nerve Stimulation on Pain and ... The goal of this clinical trial is to examine the effect of vagus nerve stimulation (VNS) on chronic, widespread pain in adults.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10614462/

Role of Vagus Nerve Stimulation in the Treatment of Chronic ... This review aimed to provide an update on both preclinical and clinical studies of VNS in the management for chronic pain, including fibromyalgia, abdominal ...

3. polscientific.com polscientific.com/journal/JBM/articles/online_first/386

Vagus nerve stimulation for chronic pain management VNS has shown the most promising results in pain reduction for headache and migraine, with less relief in inflammatory and neuropathic pain as compared to ...

4. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2024.1402918/full

Editorial: Non-invasive and minimally invasive vagus nerve ... Noninvasive vagus nerve stimulation has been demonstrated to be effective in treating underlying pain pathology as well as numerous comorbid conditions.

5. link.springer.com link.springer.com/article/10.1007/s40122-024-00657-8

Clinical Efficacy of Auricular Vagus Nerve Stimulation in ... This systematic review and meta-analysis indicate that aVNS can be an effective and safe non-drug treatment in patients with specific chronic and acute ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25000609

Vagus nerve stimulation therapy for treatment-resistant PTSD VNS therapy was safe and feasible to deliver. •. After therapy, all participants no longer met the criteria for PTSD diagnosis. •.

7. mayoclinic.org mayoclinic.org/tests-procedures/vagus-nerve-stimulation/about/pac-20384565

Vagus nerve stimulation Having a vagus nerve stimulator put into the body is safe for most people. But it does have some risks. These come both from the surgery to ...