NeuromodulationVNS-EPSNCT05350150
Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study
A study testing Auricular Vagal Nerve Stimulation in people with Neuromodulation, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromodulation
- What is being tested?
- Auricular Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)
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.
Read the detailed 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.
- Conditions
- Neuromodulation
- Being tested
- Auricular Vagal Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Vagal Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Vagal Nerve Stimulation | Experimental | 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. Receives: Device: Auricular Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sinus Cycle Length
Sinus cycle length (msec)
Measured: Pre procedure/procedure
Change in A-H Interval
A-H Interval (msec)
Measured: Pre procedure/procedure
Change in H-V Interval
H-V interval (msec)
Measured: Pre procedure/procedure
Change in QRS Duration
QRS Duration (msec)
Measured: Pre procedure/procedure
Change in QT Duration
QT Duration (msec)
Measured: Pre procedure/procedure
Change in Sinus Node Recovery Time
Sinus Node Recovery Time (msec)
Measured: Pre procedure/procedure
Change in AV Node Wenckebach Cycle Length
AV Node Wenckebach Cycle Length (msec)
Measured: Pre procedure/procedure
Change in AV Node Effective Refractory Period
AV Node Effective Refractory Period (ERP) (msec)
Measured: Pre procedure/procedure
Change in Atrial Effective Refractory Period
Atrial Effective Refractory Period ERP (msec)
Measured: Pre procedure/procedure
Change in Right Ventricular Effective Refractory Period ERP
Right Ventricular Effective Refractory Period ERP (msec)
Measured: Pre procedure/procedure
Change in retrograde block cycle length
Retrograde Block Cycle Length (msec)
Measured: Pre procedure/procedure
Change in Accessory Pathway Anterograde Effective Refractory Period ERP
Accessory Pathway Anterograde Effective Refractory Period (msec)
Measured: Pre procedure/procedure
Change in Accessory Pathway Retrograde Effective Refractory Period ERP
Accessory Pathway Anterograde Effective Refractory Period (msec)
Measured: Pre procedure/procedure
Supraventricular Tachycardia induction
Supraventricular Tachycardia induction
Measured: Pre procedure/procedure
Supraventricular Tachycardia Termination
Supraventricular Tachycardia Termination
Measured: Pre procedure/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start22 Aug 2022
- Primary completion6 Apr 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeuromodulationStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Stavros E Mountantonakis, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350150
- Sponsor's protocol ID
- 21-1109
- Acronym
- VNS-EPS
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32192678Stavrakis 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.
PubMed 25744003Stavrakis 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.
PubMed 35023349
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)
- ClinicalTrials.gov ID
- NCT05350150
- Acronym / sponsor ID
- VNS-EPS / 21-1109
- Conditions
- Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auricular Vagal Nerve Stimulation | Experimental | Device: Auricular Vagal Nerve StimulationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Vagal Nerve StimulationThe Parasym device will be placed on the patient's left tragus to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve. | Device | Auricular Vagal Nerve Stimulation |
Primary outcome
Change in Sinus Cycle Length
Time frame: Pre procedure/procedure
Sinus cycle length (msec)
Change in A-H Interval
Time frame: Pre procedure/procedure
A-H Interval (msec)
Change in H-V Interval
Time frame: Pre procedure/procedure
H-V interval (msec)
Change in QRS Duration
Time frame: Pre procedure/procedure
QRS Duration (msec)
Change in QT Duration
Time frame: Pre procedure/procedure
QT Duration (msec)
Change in Sinus Node Recovery Time
Time frame: Pre procedure/procedure
Sinus Node Recovery Time (msec)
Change in AV Node Wenckebach Cycle Length
Time frame: Pre procedure/procedure
AV Node Wenckebach Cycle Length (msec)
Change in AV Node Effective Refractory Period
Time frame: Pre procedure/procedure
AV Node Effective Refractory Period (ERP) (msec)
Change in Atrial Effective Refractory Period
Time frame: Pre procedure/procedure
Atrial Effective Refractory Period ERP (msec)
Change in Right Ventricular Effective Refractory Period ERP
Time frame: Pre procedure/procedure
Right Ventricular Effective Refractory Period ERP (msec)
Change in retrograde block cycle length
Time frame: Pre procedure/procedure
Retrograde Block Cycle Length (msec)
Change in Accessory Pathway Anterograde Effective Refractory Period ERP
Time frame: Pre procedure/procedure
Accessory Pathway Anterograde Effective Refractory Period (msec)
Change in Accessory Pathway Retrograde Effective Refractory Period ERP
Time frame: Pre procedure/procedure
Accessory Pathway Anterograde Effective Refractory Period (msec)
Supraventricular Tachycardia induction
Time frame: Pre procedure/procedure
Supraventricular Tachycardia induction
Supraventricular Tachycardia Termination
Time frame: Pre procedure/procedure
Supraventricular Tachycardia Termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 32192678Stavrakis 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.
- Background: PubMed 25744003Stavrakis 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.
- Background: PubMed 35023349Stavrakis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros E Mountantonakis, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Vagal Nerve Stimulation in people with Neuromodulation, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sinus Cycle Length (time frame: Pre procedure/procedure). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350150, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.