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

Northwell Health

Status: Enrolling

Conditions: Neuromodulation

Treatments: Device: Auricular Vagal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05350150

21-1109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Auricular Vagal Nerve Stimulation

Experimental group

Description:

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.

Treatment:

Device: Auricular Vagal Nerve Stimulation