Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

Study Overview
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Brief Summary
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The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system.

Detailed Description
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The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system. In this study, we will enroll 10 healthy individuals presenting to the electrophysiology laboratory for an electrophysiological study (EPS). Patients will undergo a standard EPS with 4 catheters (coronary sinus catheter, His catheter, right ventricular catheter, and right atrial catheter). 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.

Official Title
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Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)

Conditions
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Neuromodulation

Intervention / Treatment
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* Device: Auricular Vagal Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia. Exclusion Criteria: Previous EPS with ablation Previous failed ablation Known conduction system disease, right or left bundle branch block on EKG Pregnant women History of postural orthostatic tachycardia syndrome Patients who have had prior cervical vagotomy Patients with skin on the tragus that is broken or cracked Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular Vagal Nerve Stimulation<br>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. | Device: Auricular Vagal Nerve Stimulation<br>* The Parasym device will be placed on the patient's left tragus to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sinus Cycle Length | Sinus cycle length (msec) | Pre procedure/procedure | 
| Change in A-H Interval | A-H Interval (msec) | Pre procedure/procedure | 
| Change in H-V Interval | H-V interval (msec) | Pre procedure/procedure | 
| Change in QRS Duration | QRS Duration (msec) | Pre procedure/procedure | 
| Change in QT Duration | QT Duration (msec) | Pre procedure/procedure | 
| Change in Sinus Node Recovery Time | Sinus Node Recovery Time (msec) | Pre procedure/procedure | 
| Change in AV Node Wenckebach Cycle Length | AV Node Wenckebach Cycle Length (msec) | Pre procedure/procedure | 
| Change in AV Node Effective Refractory Period | AV Node Effective Refractory Period (ERP) (msec) | Pre procedure/procedure | 
| Change in Atrial Effective Refractory Period | Atrial Effective Refractory Period ERP (msec) | Pre procedure/procedure | 
| Change in Right Ventricular Effective Refractory Period ERP | Right Ventricular Effective Refractory Period ERP (msec) | Pre procedure/procedure | 
| Change in retrograde block cycle length | Retrograde Block Cycle Length (msec) | Pre procedure/procedure | 
| Change in Accessory Pathway Anterograde Effective Refractory Period ERP | Accessory Pathway Anterograde Effective Refractory Period (msec) | Pre procedure/procedure | 
| Change in Accessory Pathway Retrograde Effective Refractory Period ERP | Accessory Pathway Anterograde Effective Refractory Period (msec) | Pre procedure/procedure | 
| Supraventricular Tachycardia induction | Supraventricular Tachycardia induction | Pre procedure/procedure | 
| Supraventricular Tachycardia Termination | Supraventricular Tachycardia Termination | Pre procedure/procedure |