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| Name | Class |
|---|---|
| Parasym Ltd. | INDUSTRY |
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Non-invasive vagus nerve stimulation has been clinically tested for the treatment cardiac arrhythmias. However, prior studies have shown mixed results-possibly in part due to inadequate stimulation duration. Therefore, we have designed an investigator-initiated early feasibility study to evaluate safety, tolerability, and compliance with prolonged, nocturnal auricular nerve stimulation using the Parasym device.
The study will utilize the Parasym transcutaneous auricular vagal nerve stimulation device. This small, battery-powered device delivers electrical stimulation through an ear clip attached to the tragus. Participants will self-administer the stimulation once daily, at bedtime, for 6 continuous hours. The device has two settings to facilitate our RCT: active treatment and sham control. After one month in the first treatment arm, participants will be crossed over to the other arm of the study. Participants and outcome assessors will be blinded to the allocation. The primary outcomes will be assessed via standardized questionnaires administered by blinded outcome assessors. The secondary outcome of PVC burden will be assessed by non-invasive event monitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Active stimulation followed by crossover to Sham stimulation | Experimental |
| |
| Arm 2: Sham stimulation followed by crossover to Active stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended nocturnal use of auricular vagus nerve stimulator device | Device | Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The occurrence of adverse events (AEs) throughout the study - including major, minor, severe adverse events and whether they lead to discontinuation of the device | 10 weeks (duration of entire study) |
| Tolerability | Participants will rate tolerability of wearing the device at night at multiple pre-specified time points throughout the study | 10 weeks |
| Quality of Life | Participants will rate quality of life at multiple pre-specified time points throughout the study | 10 weeks |
| Feasibility | Participants will rate ease of wearing the device at night at multiple pre-specified time points throughout the study | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PVC burden | PVC burden will be tracked by event monitoring at pre-specified time points throughout the study | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PVC Burden stratified by timing | PVC burden during night time 12 hours and day time 12 hours will be compared to see if there is a significant difference | 10 weeks |
| Heart rate variability (HRV) | HRV will be tracked throughout the study via event monitors at prespecified time points |
Inclusion Criteria
Individuals must meet all of the following inclusion criteria to be eligible to participate in this study:
Age ≥ 18 years
PVC burden ≥ 5% documented on an event monitor or implanted cardiac device
Provide written informed consent
Willingness to comply with all study procedures
Availability for the duration of the study (10 weeks)
Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation:
Unwilling or unable to provide informed consent for oneself
Last available left ventricular ejection fraction < 20%
NYHA Class IV symptoms
Acute coronary syndrome within two weeks of randomization
Active pregnancy or breastfeeding
Intention to become pregnant
Statement Regarding Equitable Selection:
This study will not exclude specific populations based on age, sex, race, or ethnicity. The inclusion/exclusion criteria are based on clinical factors relevant to the study intervention and the safety of participants. Limited English proficiency will not be an exclusion criterion, and appropriate translation services will be provided to ensure informed consent and understanding of study procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health System | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36543841 | Result | Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1. | |
| 39402309 | Result | Gentile F, Giannoni A, Navari A, Degl'Innocenti E, Emdin M, Passino C. Acute right-sided transcutaneous vagus nerve stimulation improves cardio-vagal baroreflex gain in patients with chronic heart failure. Clin Auton Res. 2025 Feb;35(1):75-85. doi: 10.1007/s10286-024-01074-9. Epub 2024 Oct 14. |
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IPD will be shared if requested by the receiving journal or reviewer. We will de-identify the data prior to providing this information.
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| 10 weeks |
| 37727325 | Result | Hua K, Cummings M, Bernatik M, Brinkhaus B, Usichenko T, Dietzel J. Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials. Front Neurosci. 2023 Sep 1;17:1227858. doi: 10.3389/fnins.2023.1227858. eCollection 2023. |
| 25573069 | Result | Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6. |
| 32192678 | Result | 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. |
| 37999672 | Result | Stavrakis S, Chakraborty P, Farhat K, Whyte S, Morris L, Abideen Asad ZU, Karfonta B, Anjum J, Matlock HG, Cai X, Yu X. Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. JACC Clin Electrophysiol. 2024 Feb;10(2):346-355. doi: 10.1016/j.jacep.2023.10.015. Epub 2023 Nov 22. |
| 38173801 | Result | Chakraborty P, Farhat K, Morris L, Whyte S, Yu X, Stavrakis S. Non-invasive Vagus Nerve Simulation in Postural Orthostatic Tachycardia Syndrome. Arrhythm Electrophysiol Rev. 2023 Dec 13;12:e31. doi: 10.15420/aer.2023.20. eCollection 2023. |
| 25187002 | Result | Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1. |
| 27058909 | Result | Gold MR, Van Veldhuisen DJ, Hauptman PJ, Borggrefe M, Kubo SH, Lieberman RA, Milasinovic G, Berman BJ, Djordjevic S, Neelagaru S, Schwartz PJ, Starling RC, Mann DL. Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial. J Am Coll Cardiol. 2016 Jul 12;68(2):149-58. doi: 10.1016/j.jacc.2016.03.525. Epub 2016 Apr 4. |
| 25176942 | Result | Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31. |
| 21030409 | Result | De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; CardioFit Multicenter Trial Investigators. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J. 2011 Apr;32(7):847-55. doi: 10.1093/eurheartj/ehq391. Epub 2010 Oct 28. |
| 14662714 | Result | Li M, Zheng C, Sato T, Kawada T, Sugimachi M, Sunagawa K. Vagal nerve stimulation markedly improves long-term survival after chronic heart failure in rats. Circulation. 2004 Jan 6;109(1):120-4. doi: 10.1161/01.CIR.0000105721.71640.DA. Epub 2003 Dec 8. |
| 4398792 | Result | Eckberg DL, Drabinsky M, Braunwald E. Defective cardiac parasympathetic control in patients with heart disease. N Engl J Med. 1971 Oct 14;285(16):877-83. doi: 10.1056/NEJM197110142851602. No abstract available. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |