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Auricular Vagus Stimulation and Heart Rate Variability
Sponsor: Bakulev Scientific Center of Cardiovascular Surgery
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.
Official title: Transcutaneous Electrical Auricular Vagus Stimulation and Heart Rate Variability
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2022-12-01
Completion Date
2026-07-01
Last Updated
2025-06-18
Healthy Volunteers
Yes
Interventions
TENS
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.
Locations (3)
Federal Center for Cardiovascular Surgery (Astrakhan)
Astrakhan, Russia
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Krasnodar, Russia
Bakulev National Medical Research Center for Cardiovascular Surgery
Moscow, Russia