Vagus Nerve Stimulation for Neuromodulation

(VNS-EPS Trial)

Overseen By Kristie Coleman, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Conduction disease, Pregnancy, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how auricular vagus nerve stimulation (aVNS) affects the heart's electrical system. The goal is to determine if this treatment can aid individuals with specific heart rhythm issues, particularly those undergoing tests to understand their heart's electrical pathways. Participants should already be scheduled for an electrophysiological study (EPS) to evaluate their heart's conduction system or have supraventricular tachycardia, a type of fast heartbeat. This trial does not suit individuals with previous heart procedures, certain heart diseases, or implanted medical devices. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for heart rhythm issues.

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 or your doctor.

What prior data suggests that this technique is safe for neuromodulation?

Research shows that auricular vagus nerve stimulation (aVNS) is generally safe. Studies find that effects are usually mild and short-lasting. Most people experience only minor side effects, such as skin irritation at the device site, headaches, or occasionally a sore throat. Importantly, no serious problems have been reported. This non-invasive treatment does not involve surgery or entering the body. Its use for conditions like migraines suggests its safety. Overall, the safety data appears promising for those considering participation in a trial with this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular vagal nerve stimulation because it offers a unique way to modulate nerve activity using the body's own systems. Unlike traditional treatments that might involve medications or invasive procedures, this method uses a device to deliver electrical stimulation to the auricular branch of the vagus nerve. This non-invasive approach could potentially reduce side effects and offer a new avenue for treating conditions influenced by nerve activity, making it a promising option for patients who don't respond well to existing therapies.

What evidence suggests that auricular vagal nerve stimulation is effective for cardiac conduction system modulation?

Research shows that stimulating the vagus nerve in the ear (aVNS) positively affects the nervous system. Studies have found that aVNS reduces symptoms of depression and anxiety, improving emotional well-being. It also helps people with insomnia sleep better. Additionally, aVNS is a safe and manageable treatment. These findings suggest that aVNS might benefit heart health by adjusting nerve activity. Participants in this trial will receive Auricular Vagal Nerve Stimulation to explore these potential benefits further. ^{1 2 6 7 8}

Who Is on the Research Team?

Stavros E Mountantonakis, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for individuals needing an electrophysiological study (EPS) to check their heart's electrical system or to investigate rapid heartbeats. It's not open to those who've had previous EPS with ablation, known conduction issues in the heart, are pregnant, have certain cardiovascular diseases, a history of vagotomy, skin conditions on the tragus, or active implanted medical devices.

Inclusion Criteria

I need a heart test to check for abnormal rhythms.

Exclusion Criteria

Pregnant women

My skin on the tragus is broken or cracked.

Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Electrophysiological Study

Participants undergo a standard electrophysiological study with 4 catheters

1 day

1 visit (in-person)

Vagus Nerve Stimulation

Participants receive transcutaneous electrical stimulation to the auricular branch of the vagus nerve using a Parasym device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Vagal Nerve Stimulation

Trial Overview The study tests auricular vagus nerve stimulation (aVNS), a non-invasive method that may affect the cardiac conduction system. Participants will undergo this stimulation during their scheduled EPS procedure at a single center in a pilot and prospective setup.

How Is the Trial Designed?

Group I: Auricular Vagal Nerve Stimulation Experimental Treatment 1 Intervention

Patients will undergo a standard EPS with 4 catheters. Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve, EPS will be repeated.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120162/

Auricular Vagus Neuromodulation—A Systematic Review on ... Auricular vagus nerve stimulation (aVNS) delivered percutaneously or transcutaneously offers a method to modulate neural activity on the vagus nerve with the ...

2. 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.

3. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... Our review found that taVNS methods up to date are safe and tolerable, leaving room for future developers to improve the reported patient ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000327

Accelerated Transcutaneous Auricular Vagus Nerve ... In this open label study, taVNS significantly decreased depression and anxiety symptoms in patients admitted to the inpatient unit.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ... Previous studies have demonstrated that taVNS cannot only effectively improve sleep quality in patients with insomnia, but also alleviate accompanying symptoms ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30217648/

Safety and tolerability of Transcutaneous Vagus Nerve ... The most common side effects were: local skin irritation from electrode placement (240 participants, 18.2%), headache (47, 3.6%) and nasopharyngitis (23, 1.7%).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841445/

A pooled analysis of the side effects of non-invasive ... These findings demonstrate a favorable safety profile of taVNS, with mostly mild and transient effects, supporting its use as a suitable non-invasive tool.

8. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Vagal_Nerve_Stimulation.pdf

Vagal nerve stimulation The gammaCore Sapphire™ tcVNS device has FDA clearance for the treatment and prevention of migraine and cluster headaches. Transcutaneous auricular VNS (taVNS) ...