Vagus Nerve Stimulation for Autonomic Nervous System Activity

Autonomic Nervous System Imbalance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05906940
• Other study ID #: AP0005
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Bahçesehir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance

Intervention

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.

Locations

Country	Name	City	State
Turkey	Igdir University	Igdir	Igdir Central

Sponsors (1)

Lead Sponsor	Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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