Auricular Vagus Stimulation and Heart Rate Variability

NCT05680337 | Recruiting

• 1 other identifier: #6
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

Transcutaneous electrical stimulation of the auricular vagus nerve (TENS) is a promising method of neuromodulation of the autonomic nervous system in patients with various pathologies. The use of this method requires the determination of a reliable biomarker of successful activation of the vagus nerve using TENS. Currently, most studies focus on the assessment of heart rate variability (HRV) as a marker of the functioning of the autonomic nervous system. Despite the physiological justification of HRV as a biomarker for TENS, the data on the effects of TENS on HRV are ambiguous. In some studies, a significant decrease in the ratio of spectral characteristics (LF/HF) in active TENS was found in comparison with fictitious stimulation (sham), which indicated an increase in the parasympathetic component of HRV. However, other studies have not revealed an increase in HRV.

Conditions

Vagus Nerve Stimulation; Heart Rate Variability

Keywords

auricular stimulation; auricular vagus nerve stimulation; heart rate; transcutaneous vagus nerve stimulation (TENS); vagus nerve stimulation (VNS); heart rate variability; power of high-frequency oscillations (HF); power of low-frequency oscillations (LF); power of very low frequency oscillations (VLF); power of ultra-low frequency oscillations (ULF); LF/HF; index centralization (IC); index of vegetative balance (IVB)

Outcome Measures

Primary Outcomes (1)

• Dynamics of LF/HF

  Changes in the level of LF /HF relative to the initial and after the end of stimulation in the groups of active and fictitious stimulation

  This parameter will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

Secondary Outcomes (9)

• HR dynamics

  This parameter will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

• Dynamics of SDNN

  This parameter will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

• Dynamics of IVB

  This parameter will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

• Dynamics of IC1

  This parameter will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

• Dynamics of IC2

  This parameter will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

Active will be performed with using a TENS device with an ear clip attached to the tragus of the left ear (which is innervated by auricular branch of the vagus nerve) at 20 Hz, 200 μs at a current just below discomfort threshold.

Device: TENS

Sham TENS

SHAM COMPARATOR

Sham will be performed with using a TENS device with an ear clip attached to the left earlobe (which is devoid of vegas innervation) at 20 Hz, 200 μs at a current just below discomfort threshold.

Device: TENS

Interventions

TENS DEVICE

TENS stimulation will occur within 10 minutes. HRV parameters will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

Active TENS; Sham TENS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sinus rhythm at the time of registration

You may not qualify if:

• Frequent ventricular / supraventricular extrasystole, 2d/3d degree AV Block
• Taking glucocorticosteroids in the last 1 month
• Taking any antiarrhythmics, except beta blockers
• Severe chronic renal or liver pathology

Sponsors & Collaborators

• Bakulev Scientific Center of Cardiovascular Surgery: lead
• State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital: collaborator
• Astrakhan Federal Centre For Cardiac Surgery: collaborator

Study Sites (3)

Federal Center for Cardiovascular Surgery (Astrakhan)

Astrakhan, Russia

RECRUITING

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Krasnodar, Russia

RECRUITING

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, 121552, Russia

RECRUITING

Related Publications (2)

• Shvartz, V.; Sizhazhev, E.; Sokolskaya, M.; Koroleva, S.; Enginoev, S.; Kruchinova, S.; Shvartz, E.; Golukhova, E. The Effect of Short-Term Transcutaneous Electrical Stimulation of Auricular Vagus Nerve on Parameters of Heart Rate Variability. Data 2023, 8, 87. https://doi.org/10.3390/data8050087

  RESULT

• Shvartz V.A., Sizhazhev E.M. Percutaneous stimulation of the auricular branch of the vagus: the potential of the method of treatment of different cardiovascular diseases. Clinical Physiology of Circulation. 2023; 20 (1): 5-15 (in Russ.). DOI: 10.24022/1814-6910-2023-20-1-5-15

  RESULT

Related Links

• International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020)
• Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature
• Does transcutaneous auricular vagus nerve stimulation affect vagally mediated heart rate variability? A living and interactive Bayesian meta-analysis

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Vladimir Shvartz

  Bakoulev Scientific Center for Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Shvartz

CONTACT

+79032619292; vashvarts@bakulev.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DM, Professor

Model Details: 1:1 randomization of active stimulation vs. sham stimulation

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 11, 2023
• Study Start: December 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2023
• Access Criteria: open access

Locations

RU (3)