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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neuromodulation
• Intervention / Treatment: Device: Auricular Vagal Nerve Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Kristie Coleman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Auricular Vagal Nerve Stimulation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: University of Oklahoma
• Investigators: Principal Investigator: Stavros E Mountantonakis, MD, Northwell Health

Publications and helpful links

General Publications

• Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026.
• Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.
• Stavrakis S, Elkholey K, Morris L, Niewiadomska M, Asad ZUA, Humphrey MB. Neuromodulation of Inflammation to Treat Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Clinical Trial. J Am Heart Assoc. 2022 Feb;11(3):e023582. doi: 10.1161/JAHA.121.023582. Epub 2022 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): April 6, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 21-1109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes