Vagus Nerve Stimulation for Neuropathy

RM
ML
Overseen ByMarlon L Wong, PT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive treatment called Transcutaneous Auricular Vagus Nerve Stimulation (AVNS), which stimulates the ear to understand nerve pain in people living with HIV. The research aims to assess how this treatment affects heart function and pain signals, potentially leading to improved future treatments for nerve pain. Participants will either receive the ear stimulation treatment or be placed on a waitlist. The trial seeks individuals with HIV who have experienced nerve pain in a glove-like or stocking-like pattern for at least three months and have stable medical care. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for nerve pain.

What prior data suggests that this device is safe for nerve pain treatment?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe and well-tolerated by patients. Studies have found that this non-invasive treatment carries minimal risk. For instance, one trial reported that patients using taVNS at home experienced only a few minor side effects. Another study confirmed that taVNS was easy to use and well-tolerated, with no major negative effects. This evidence suggests that taVNS is a promising and safe option for managing nerve-related conditions.12345

Why are researchers excited about this trial?

Unlike the standard treatments for neuropathy, which often include medications like pain relievers, antidepressants, or anticonvulsants, transcutaneous auricular vagus nerve stimulation (AVNS) offers a non-invasive alternative by stimulating the vagus nerve through the ear. This method doesn't rely on drugs, which means it could potentially avoid the side effects commonly associated with medication. Researchers are excited about AVNS because it targets the nervous system directly, offering a novel approach that might bring relief faster and more effectively for some patients. Plus, the ease of administering AVNS could make it more accessible for a broader range of patients.

What evidence suggests that this device is effective for neuropathy?

Research has shown that transcutaneous auricular vagus nerve stimulation (AVNS) can relieve pain and improve other symptoms. One study found that AVNS significantly reduced pain and tiredness in patients with systemic lupus erythematosus (SLE), an autoimmune disease. The vagus nerve controls body functions like heart rate and digestion, and stimulating it can alter the body's pain response. Additionally, vagus nerve stimulation (VNS) has treated conditions like epilepsy and depression, suggesting it may help with nerve-related issues. In this trial, participants in the Auricular Vagus Nerve (AVNS) Group will receive AVNS sessions, while those in the Waitlist Control group will not receive an intervention during the study period. These findings suggest that AVNS might also be effective for nerve pain in people living with HIV.678910

Who Is on the Research Team?

ML

Marlon L. Wong, PT, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for people living with HIV who have nerve pain in their hands or feet. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I have had numbness or tingling in my hands or feet for at least 3 months.
My HIV or pain medications have not changed in the last 2 months.
I have been diagnosed with HIV.
See 2 more

Exclusion Criteria

I have cancer in my head or neck, or it has spread there.
I have another health condition, like recent chemo or uncontrolled diabetes, causing nerve damage.
Implanted electronic or magnetic devices such as pacemaker, cochlear implants, medication pumps, and other implanted neurostimulation systems
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 6 sessions of transcutaneous auricular vagus nerve stimulation (AVNS) over 2 weeks, with each session lasting approximately 90 minutes.

2 weeks
6 visits (in-person)

Waitlist Control

Participants in the control group are assessed pre and post a 2-week waiting period without receiving any intervention.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including changes in neuropathic symptom intensity and other biomarkers.

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)

Trial Overview

The study tests a non-invasive treatment called auricular vagus nerve stimulation (AVNS), which uses gentle electrical pulses on the ear to see if it can help reduce nerve pain and affect heart and nervous system responses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Auricular Vagus Nerve (AVNS) GroupExperimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric ...

A pilot study that examined the application of VNS in 60 patients with treatment-resistant showed a significant clinical improvement in 30–37% ...

Vagus Nerve: What It Is, Function, Location & Conditions

The vagal nerves aid body functions during rest and digestion. Vagus nerve damage can lead to gastroparesis, an inability to digest food.

Feinstein Institutes unveils world's first comprehensive vagus ...

It manages autonomic functions such as heart rate, breathing, and digestion, and serves as the body's “on/off switch” for immune response and ...

The vagus nerve promotes memory in rats via nutrient ...

The vagus nerve relays critical metabolic information between the gastrointestinal tract and the brain. Recent findings highlight a role for ...

Vagus nerve

Vagus nerve stimulation (VNS) therapy via a neurostimulator been used to control seizures in epilepsy patients and has been approved for treating drug- ...

A randomized, sham-controlled pilot trial with blinded outcome ...

transcutaneous auricular vagus nerve stimulation (taVNS) was feasible and well tolerated. higher in the taVNS group

Clinical Efficacy of Auricular Vagus Nerve Stimulation ...

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 ...

Efficacy of Transcutaneous Auricular Vagus Nerve ...

Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising adjunct in post-stroke rehabilitation, but its effectiveness and safety remain unclear.

NCT07804199 | taVNS in Veterans With Knee OA (AVAHCS)

Transcutaneous auricular vagus nerve stimulation (taVNS) is a self-administered, home-based, non-invasive therapy with minimal risk of side ...

Effects of Transcutaneous Auricular Vagus Nerve Stimulation ...

Background and Objectives. Intracerebral hemorrhage (ICH) is one of the major stroke subtypes leading to severe disability and mortality.