Vagus Nerve Stimulation for Autonomic Nervous System Activity

January 3, 2024 updated by: Alper Percin, Bahçeşehir University

Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity

There are no generally accepted values for transcutaneous vagus nerve stimulation (taVSS application parameters (amplitude, frequency, intensity, duration, side) yet, therefore there are heterogeneous applications in studies. Although positive effects have been shown in different neurological, psychiatric and musculoskeletal diseases, taVSS treatment is not available yet. It is not clear which parameters are important in patient selection.In this study, it was aimed to investigate the change of taVSS effect in healthy individuals according to the level of autonomic nervous system activity before stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy individuals between the ages of 18-45 without any disease will be included in the study. Male and female participants will be included in the study. Heart rate variability will be measured after participants are included in the study. A short 5-minute measurement will be made with the Polar H7 device, which can be measured with the belt attached to the chest. Heart Rate Variability measurement will be analyzed with the Kubios HRV program. Participants will be distributed to groups according to the SNS index and PNS index values obtained as a result of the Kubios analysis. According to the index scores obtained, the distribution of the groups will be made as <-2, between -2 and +2 and >2. Afterwards, 20 minutes of taVSS stimulation will be performed. As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz (Heartz), pulse width of 300 µs (microseconds) for 20 minutes, biphasic application will be given to each participant 2 times, with at least 48 hours between them.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Iğdır Central
      • Iğdır, Iğdır Central, Turkey, 76000
        • Iğdır University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy participants between the ages of 18-45 will be included in the study.

Exclusion Criteria:

  • Having an acute or chronic disease,
  • Having previously undergone transcutaneous vagus nerve stimulation,
  • Not smoking or using alcohol,
  • Being in the post-menopausal stage in women,
  • Being in the post-andropausal period in men,
  • Being on constant medication,
  • In menstruating women, stimulation and heart rate assessment will be postponed to the next week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Participants
Participants in this group will be measured heart rate variability before and after transcutaneous vagus nerve stimulation.
Device: Transcutaneous Vagus Nerve Stimulation
As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes, each participant will be stimulated twice, with at least 48 hours between them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability Parameters-Stress Index
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
Stress index which is a geometric measure of HRV reflecting cardiovascular system stress. High values of SI indicate reduced variability and high sympathetic cardiac activation.
5 minutes (short measurement) measurement of heart rate variability
Heart Rate Variability Parameters-RMSSD
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
RMSSD is a measure of short-term (beat-by-beat) variability. It equals the root mean square of successive differences.
5 minutes (short measurement) measurement of heart rate variability
Heart Rate Variability Parameters-LF (Low Frequency)
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
Power in the Low Frequency band of the HRV spectrum, often between 0.04 - 0.15 Hz, often reported in units of milliseconds-squared.
5 minutes (short measurement) measurement of heart rate variability
Heart Rate Variability Parameters-HF (High Frequency)
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
Power in the High Frequency band of the HRV spectrum, often between 0.15-0.40 Hz, often reported in units of milliseconds-squared.
5 minutes (short measurement) measurement of heart rate variability
Heart Rate Variability Parameters-LF/HF Ratio
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
LF/HF Ratio: A ratio of Low Frequency to High Frequency.
5 minutes (short measurement) measurement of heart rate variability
Heart Rate Variability Parameters-SNS Index
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
Sympathetic cardiac activity is known to 1) increase heart rate, 2) decrease HRV, reducing especially quick RSA related changes in RR interval, and 3) increase the ratio between lower frequency and higher frequency oscillations in HRV data
5 minutes (short measurement) measurement of heart rate variability
Heart Rate Variability Parameters-PNS Index
Time Frame: 5 minutes (short measurement) measurement of heart rate variability
Parasympathetic cardiac activity is known to 1) decrease heart rate (i.e. increase the time interval between successive heart beats), 2) increase HRV via enhanced respiratory sinus arrhythmia (RSA) component (i.e. increasing the quick changes in RR interval linked to respiration - shortening of RR intervals during inhalation and lengthening of RR intervals during exhalation), and 3) decrease the ratio between lower frequency and higher frequency oscillations in HRV time series (i.e. increase the relative amount of quick RSA originated fluctuations in HRV compared to slower short-term fluctuations)
5 minutes (short measurement) measurement of heart rate variability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Investigators

  • Study Director: Ali Veysel Özden, MD, PhD., Iğdır University Physiotherapy and Rehabilitation Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AP0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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