Vagus Nerve Stimulation for Autonomic Nervous System Activity

NCT05906940 | Completed DMC

• 1 other identifier: AP0005
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autonomic Nervous System Imbalance

Keywords

Autonomic Nervous Systems; Vagal Nerve Stimulation; Heart Rates

Outcome Measures

Primary Outcomes (7)

• Heart Rate Variability Parameters-Stress Index

  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

  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)

  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)

  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

  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

  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

  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

Study Arms (1)

Health Participants

EXPERIMENTAL

Participants in this group will be measured heart rate variability before and after transcutaneous vagus nerve stimulation.

Device: Transcutaneous Vagus Nerve Stimulation

Interventions

Transcutaneous Vagus Nerve Stimulation DEVICE

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.

Health Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Iğdır University

Iğdır, Iğdır Central, 76000, Turkey (Türkiye)

Location

Related Publications (3)

• Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.

  PMID: 25614179 RESULT

• Milby AH, Halpern CH, Baltuch GH. Vagus nerve stimulation for epilepsy and depression. Neurotherapeutics. 2008 Jan;5(1):75-85. doi: 10.1016/j.nurt.2007.10.071.

  PMID: 18164486 RESULT

• Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.

  PMID: 31742681 RESULT

Study Officials

• Ali Veysel Özden, MD, PhD.

  Iğdır University Physiotherapy and Rehabilitation Laboratory

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)