What side effects are associated with this type of intervention?

Common neuromodulation treatments such as Vagus Nerve Stimulation (VNS), Transcranial Magnetic Stimulation (TMS), and Deep Brain Stimulation (DBS) have various side effects. VNS can cause infection, hemorrhage, confusion, and seizures, with severe adverse effects being uncommon. TMS is generally safe but may cause mild headaches, scalp discomfort, or, rarely, seizures. DBS, being more invasive, can lead to hardware malfunctions, infection, hemorrhage, and stimulation-related complications, which are usually reversible by adjusting the stimulation settings. Overall, while these treatments are generally well-tolerated, they do carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments that modulate the autonomic nervous system. Vagus nerve stimulation (VNS) is one such treatment, approved for epilepsy and treatment-resistant depression. VNS involves an implanted device that sends electrical impulses to the vagus nerve. Another related treatment is transcranial magnetic stimulation (TMS), approved for major depressive disorder and obsessive-compulsive disorder. TMS uses magnetic fields to stimulate nerve cells in the brain. These treatments share similarities with Auricular Vagus Nerve Stimulation (aVNS), which is being studied for its effects on cardiac conduction by modulating the autonomic nervous system.

What other types of research exist?

Promising, novel alternatives to Auricular Vagus Nerve Stimulation (aVNS) for neuromodulation patients include: 1) Transcutaneous Vagus Nerve Stimulation (tVNS), which is non-invasive and has shown potential in modulating autonomic functions. 2) Deep Brain Stimulation (DBS), particularly targeting areas like the subthalamic nucleus, which has been effective in treating various neurological conditions and may influence autonomic regulation. 3) Transcranial Magnetic Stimulation (TMS), which is non-invasive and has been explored for its effects on the autonomic nervous system and cardiac function. These alternatives offer different mechanisms and potential benefits for patients seeking neuromodulation therapies.

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Device

Vagus Nerve Stimulation for Neuromodulation (VNS-EPS Trial)

N/A

Recruiting

Led By Stavros E Mountantonakis, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.

Be older than 18 years old

Must not have

Previous EPS with ablation

Previous failed ablation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre procedure/procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a device to send electrical pulses to the ear to affect heartbeats. It targets healthy people already having a heart study to see how this stimulation changes their heart's electrical signals.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of auricular vagus nerve stimulation can include discomfort at the site of stimulation, headache, dizziness or lightheadedness. However, since it's non-invasive and localized to the ear area, severe side effects are less likely compared to invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a heart test to check for abnormal rhythms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a procedure to treat abnormal heart rhythms.

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I had a treatment to destroy tissue that didn't work.

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I have had surgery on the nerves of my stomach.

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I have been diagnosed with postural orthostatic tachycardia syndrome.

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I have a history of heart disease or severe artery narrowing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre procedure/procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre procedure/procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre procedure/procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in A-H Interval

Change in AV Node Effective Refractory Period

Change in AV Node Wenckebach Cycle Length

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Auricular Vagal Nerve StimulationExperimental Treatment1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuromodulation treatments like auricular vagus nerve stimulation (aVNS) and transcranial magnetic stimulation (TMS) work by modulating neural activity to achieve therapeutic effects. aVNS targets the vagus nerve, which plays a crucial role in autonomic nervous system regulation, potentially affecting cardiac conduction and reducing symptoms in conditions like migraines and epilepsy. TMS uses magnetic fields to stimulate specific brain regions, which can alleviate symptoms of depression and tinnitus by altering neural circuits. These mechanisms are significant for neuromodulation patients as they offer non-invasive options to manage symptoms and improve quality of life by directly influencing neural pathways and brain activity.