Vagus Nerve Stimulation for Autonomic Nervous System Activity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Health Participants Participants in this group will be measured heart rate variability before and after transcutaneous vagus nerve stimulation. |
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.
|
Outcome Measures
Primary Outcome Measures
- Heart Rate Variability Parameters-Stress Index [5 minutes (short measurement) measurement of heart rate variability]
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.
- Heart Rate Variability Parameters-RMSSD [5 minutes (short measurement) measurement of heart rate variability]
RMSSD is a measure of short-term (beat-by-beat) variability. It equals the root mean square of successive differences.
- Heart Rate Variability Parameters-LF (Low Frequency) [5 minutes (short measurement) measurement of heart rate variability]
Power in the Low Frequency band of the HRV spectrum, often between 0.04 - 0.15 Hz, often reported in units of milliseconds-squared.
- Heart Rate Variability Parameters-HF (High Frequency) [5 minutes (short measurement) measurement of heart rate variability]
Power in the High Frequency band of the HRV spectrum, often between 0.15-0.40 Hz, often reported in units of milliseconds-squared.
- Heart Rate Variability Parameters-LF/HF Ratio [5 minutes (short measurement) measurement of heart rate variability]
LF/HF Ratio: A ratio of Low Frequency to High Frequency.
- Heart Rate Variability Parameters-SNS Index [5 minutes (short measurement) measurement of heart rate variability]
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
- Heart Rate Variability Parameters-PNS Index [5 minutes (short measurement) measurement of heart rate variability]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Healthy participants between the ages of 18-45 will be included in the study.
Exclusion Criteria:
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Having an acute or chronic disease,
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Having previously undergone transcutaneous vagus nerve stimulation,
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Not smoking or using alcohol,
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Being in the post-menopausal stage in women,
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Being in the post-andropausal period in men,
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Being on constant medication,
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In menstruating women, stimulation and heart rate assessment will be postponed to the next week.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Iğdır University | Iğdır | Iğdır Central | Turkey | 76000 |
Sponsors and Collaborators
- Bahçeşehir University
Investigators
- Study Director: Ali Veysel Özden, MD, PhD., Iğdır University Physiotherapy and Rehabilitation Laboratory
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AP0005