Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity

Bahçeşehir University

Status: Completed

Conditions: Vagus Nerve Stimulation

Treatments: Device: Transcutaneous Auricular Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06086236

AP00013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 4 patient groups

PNS Index<-2 and SNS Index>2

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

PNS Index<-2 and SNS Index<2

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

PNS Index>-2 and SNS Index>2

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

PNS Index>-2 and SNS Index<2

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation