An interventional study of Transcutaneous Vagus Nerve Stimulation in Vagus Nerve Stimulation, sponsored by Bahçeşehir University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Bahçeşehir University · Not applicable, Interventional, and Screening
The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases.
There are no generally accepted values for taVNS (transcutaneous auricular vagus nerve stimulation) application parameters (amplitude, frequency, intensity, duration, side); therefore, there are heterogeneous applications in studies. In a meta-analysis on the safety profile of taVSS, local skin irritation (18. 2%), headache (3.6%), nasopharyngitis (1.7%), dizziness (1.4%) and nausea (1.1%) were reported and taVSS treatment was reported as an effective and safe treatment with these side effects, most of which were transient and did not require additional intervention.
During taVNS, autonomic activities increase in favour of the parasympathetic system and this results in an increase in heart rate variability (HRV). Although an increase in HRV has been demonstrated by different studies, the factors that can predict the change in HRV are not clear. In a study by Geng et al. using taVSS, it was observed that HRV indicators representing vagal nerve activity increased significantly when stimulation was performed in the morning, but evening stimulation did not yield similar results. In addition, they found that improvements in measures of autonomic balance were more pronounced in the presence of lower vagal activity; they also found that by increasing the duration of stimulation, the effect of taVNS on HRV was not regulated by duration. In other words, HRV changes had the best effect only at the beginning of stimulation.
Bahçeşehir University is the lead sponsor of 117 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group underwent intra-ear transcutaneous vagus nerve simulation.
Device: Transcutaneous Vagus Nerve Stimulation
Participants in this group underwent transcutaneous vagus nerve simulation behind the ear.
Device: Transcutaneous Vagus Nerve Stimulation
In order to see the placebo effect of in-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.
Device: Transcutaneous Vagus Nerve Stimulation
In order to see the placebo effect of behind-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.
Device: Transcutaneous Vagus Nerve Stimulation
All techniques used to stimulate the vagal nerve are called vagus nerve stimulation.
Heart Rate Variability
The effectiveness of vagus nerve stimulation, its effect on autonomic nervous system activity was evaluated using heart rate variability. Polar H7 device was used for this. The heart rate was recorded non-invasively over the chest for 5 minutes and the beat-to-beat (R-R) variability was measured with Kubios software.
Time frame: Baseline and immediately after the intervention
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bahçeşehir University