Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity

October 13, 2023 updated by: Alper Percin, Bahçeşehir University

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

Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were divided into four groups (Figure 1) according to PNS and SNS indexes as Group 1 (PNS index <-2, SNS index >+2), Group 2 (PNS index <-2, SNS index <+2), Group 3 (PNS index >-2, SNS index >+2), Group 4 (PNS index >-2, SNS index <+2). Participants were assessed with blood pressure, pulse rate and HRV before and after taVNS stimulation. Sympathetic nervous system (SNS) index and parasympathetic nervous system (PNS) index values were assumed to be between -2 and +2 (95%) in the normal population according to Kubios software, and the grouping method was based on this situation.

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
    • Merkez
      • Iğdır, Merkez, Turkey, 76000
        • Igdir 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:

  • Age between 18 and 40 years old.
  • No previous vagus nerve stimulation

Exclusion Criteria:

  • Using of any drug, alcohol or smoking.
  • Pregnancy.
  • Known history of acute or chronic illness.
  • Being in the post or peri-menopausal stage.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PNS Index<-2 and SNS Index>2
Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS<-2, SNS>2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.
Experimental: PNS Index<-2 and SNS Index<2
Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS<-2, SNS<2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.
Experimental: PNS Index>-2 and SNS Index>2
Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS>-2, SNS>2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.
Experimental: PNS Index>-2 and SNS Index<2
Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS>-2, SNS<2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Rate
Time Frame: Up to 6 Months
The pulse rate of the participants was measured with an electronic blood pressure monitor.
Up to 6 Months
Systolic Blood Pressure
Time Frame: Up to 6 Months
The systolic blood pressure of the participants was measured with an electronic blood pressure monitor.
Up to 6 Months
Diastolic Blood Pressure
Time Frame: Up to 6 Months
The diastolic blood pressure of the participants was measured with an electronic blood pressure monitor.
Up to 6 Months

Collaborators and Investigators

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

Sponsor

Bahçeşehir University

Investigators

  • Principal Investigator: Alper Perçin, Ph.D., Igdir University

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)

April 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 10, 2023

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AP00013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not preferred to share the data until the study is published.

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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