Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Study Overview
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Brief Summary
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Prospective randomized control pilot study

Detailed Description
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The primary aims of this investigator initiated study is : Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.

Official Title
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Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Conditions
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Premature Ventricular Contraction

Intervention / Treatment
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* Device: Low-Level Tragus Stimulation
* Behavioral: Heart Rate Variability- Biofeedback
* Other: Conventional Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal Left Ventricular systolic function Frequent PVCs Exclusion Criteria: Current use of any (I and/or III) antiarrhythmic medication Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers Complete Atrioventricular block and pacemaker dependent Ongoing uncontrolled hypertension with systolic Blood Pressure> 180 Family history of dilated Cardiomyopathy in a first degree relative Alcohol use disorder or illicit drug use Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response Moderate to severe valve disorders Patient with shortwave/microwave therapy equipment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care.)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Level Tragus Stimulation<br>The Low-Level Tragus Stimulation will be done with TENS. | Device: Low-Level Tragus Stimulation<br>* Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.<br>* Other names: TENS;|
| Experimental: Heart Rate Variability- Biofeedback<br>Heart Rate Variability-Biofeedback will be done with a phone application. Practice sessions are at least 10-15 minutes twice a daily. | Behavioral: Heart Rate Variability- Biofeedback<br>* Heart Rate Variability- Biofeedback will be monitored with a Holter.<br>* Other names: Breathing Exercises / Inner Balance;|
| Active Comparator: Conventional Medical Therapy<br>Subjects without beta blockers will be initiated on a usual/standard care medication of beta blockers to determine the efficacy of this standard medication therapy for Premature Ventricular Contraction suppression. | Other: Conventional Medical Therapy<br>* Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication.<br>* Other names: Usual care medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions. | Compare the effects of Premature Ventricular Contractions suppression between standard medical therapy and non-invasive vagal nerve stimulation. | perspective 12-week study (each arm lasting two weeks with a one week washout between each arm) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions. | It is speculated that Heart Rate Variability-Biofeedback is as effective as Lower Level Tragus Stimulation to achieve successful Premature Ventricular Contraction suppression. | perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRV-BF- Heart rate variability biofeedback, LLTS- Low-level tragus stimulation, NIVNS Non-invasive vagal nerve stimulation