Clinical trial NCT05906940: Vagus Nerve Stimulation for Autonomic Nervous System Activity
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Keywords: Autonomic Nervous Systems
Vagal Nerve Stimulation
Heart Rates
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart Rate Variability Parameters-Stress Index
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
measure: Heart Rate Variability Parameters-RMSSD
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
measure: Heart Rate Variability Parameters-LF (Low Frequency)
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
measure: Heart Rate Variability Parameters-HF (High Frequency)
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
measure: Heart Rate Variability Parameters-LF/HF Ratio
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
measure: Heart Rate Variability Parameters-SNS Index
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
measure: Heart Rate Variability Parameters-PNS Index
timeFrame: 5 minutes (short measurement) measurement of heart rate variability
Secondary outcomes:
Other outcomes:
Locations:
city: Iğdır
country: Turkey
facility: Iğdır University
state: Iğdır Central
Study officials:
affiliation: Iğdır University Physiotherapy and Rehabilitation Laboratory
name: Ali Veysel Özden, MD, PhD.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.