Vagus Nerve Stimulation for Neuropathy
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 sessions of transcutaneous auricular vagus nerve stimulation (AVNS) over 2 weeks, with each session lasting approximately 90 minutes.
Waitlist Control
Participants in the control group are assessed pre and post a 2-week waiting period without receiving any intervention.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including changes in neuropathic symptom intensity and other biomarkers.
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
Participants in this group will receive 6 sessions of transcutaneous auricular vagus nerve stimulation (AVNS) over 2 weeks. Each stimulation session will last approximately 90 minutes at monophasic pulses.
Participants in this group will not receive an intervention. Participants will be placed on a waitlist to try the intervention and will be assessed pre and post the 2-week waiting period. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day waitlist period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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.
3.
feinstein.northwell.edu
feinstein.northwell.edu/news/the-latest/feinstein-institutes-unveils-worlds-first-comprehensive-vagus-nerve-mapFeinstein 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 ...
10.
journals.plos.org
journals.plos.org/plosone/article/file?type=supplementary&id=10.1371/journal.pone.0352321.s002Effects 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.
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