Vagus Nerve Stimulation for Autonomic Nervous System Activity

Bahçeşehir University

Status

Completed

Conditions

Autonomic Nervous System Imbalance

Treatments

Device: Transcutaneous Vagus Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05906940

AP0005

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.