Vagus Nerve Stimulation for Neuromodulation
(VNS-EPS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byStavros E Mountantonakis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a device to send electrical pulses to the ear to affect heartbeats. It targets healthy people already having a heart study to see how this stimulation changes their heart's electrical signals.

Research Team

Stavros E Mountantonakis, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for individuals needing an electrophysiological study (EPS) to check their heart's electrical system or to investigate rapid heartbeats. It's not open to those who've had previous EPS with ablation, known conduction issues in the heart, are pregnant, have certain cardiovascular diseases, a history of vagotomy, skin conditions on the tragus, or active implanted medical devices.

Inclusion Criteria

I need a heart test to check for abnormal rhythms.

Exclusion Criteria

Pregnant women

My skin on the tragus is broken or cracked.

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.

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Treatment Details

Interventions

Auricular Vagal Nerve Stimulation (Device)

Trial OverviewThe study tests auricular vagus nerve stimulation (aVNS), a non-invasive method that may affect the cardiac conduction system. Participants will undergo this stimulation during their scheduled EPS procedure at a single center in a pilot and prospective setup.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Auricular Vagal Nerve StimulationExperimental Treatment1 Intervention

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.