Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

Neuromodulation Clinical Trial

— VNS-EPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350150
• Other study ID #: 21-1109
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Northwell Health
• Contact: Kristie Coleman, RN
• Phone: 2124346500
• Email: kcoleman1[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuromodulation

Intervention

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.

Locations

Country	Name	City	State
United States	Kristie Coleman	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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