Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vagus Nerve Stimulation

Intervention / Treatment
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* Device: Transcutaneous Auricular Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After the participants were included in the study, heart rate variability was measured and divided into 4 groups according to PNS and SNS indexes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNS Index<-2 and SNS Index>2<br>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<br>* Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.<br>|
| Experimental: PNS Index<-2 and SNS Index<2<br>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<br>* Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.<br>|
| Experimental: PNS Index>-2 and SNS Index>2<br>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<br>* Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.<br>|
| Experimental: PNS Index>-2 and SNS Index<2<br>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<br>* Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vagus Nerve Stimulations, Diastolic Pressure, Pulse Rate, Systolic Pressure