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

Northwell Health2 sites in 1 country10 target enrollmentAugust 22, 2022

ConditionsNeuromodulation

InterventionsAuricular Vagal Nerve Stimulation

Overview

Phase: Not Applicable
Intervention: Auricular Vagal Nerve Stimulation
Conditions: Neuromodulation
Sponsor: Northwell Health
Enrollment: 10
Locations: 2
Primary Endpoint: Change in Sinus Cycle Length
Status: Active, not recruiting
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

August 22, 2022

End Date

July 30, 2026

Last Updated

17 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Northwell Health

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Auricular Vagal Nerve Stimulation

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.

Intervention: Auricular Vagal Nerve Stimulation