Exploring the effects of mechanical vagus nerve stimulation on healthy adults
Balance, Sensory Modulation, and Autonomic Response to Different Dosages of Non-invasive Mechanical Vagal Stimulation in Healthy Adults
This study is testing how different neck movements that stimulate the vagus nerve can affect heart rate, balance, pain, and gut function in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Vienna Academic / other |
| Locations | 1 site (Vienna, Wien) |
| Trial ID | NCT06541808 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of mechanical vagus nerve stimulation (mVNS) on various physiological parameters in healthy adults. It aims to evaluate how different durations of non-invasive neck movements can influence heart rate, balance, pain perception, and gut function. A total of 96 participants aged 18 to 60 will undergo three different mVNS protocols, with outcomes assessed before and after stimulation. The study seeks to refine the stimulation protocol and understand the dose-dependent effects of mVNS.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 60 who do not have significant neck pain or other disqualifying health conditions.
Not a fit: Patients with significant neck pain, recent surgeries, or underlying health issues such as diabetes or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method for modulating autonomic functions and improving conditions related to heart rate and pain.
How similar studies have performed: Previous studies on mechanical vagus nerve stimulation have shown promising results in chronic pain patients, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * agreement to participate by signing the informed consent form, being 18-60 years old, and sober Exclusion Criteria: * participants having significant neck pain, headache, or leg pain \[with Numeric Pain Rating Scale (NPRS) greater than 3/10\], * pregnancy * recent neck or cardiovascular surgery or significant trauma in the preceding 3 months * diagnosis of cancer or inflammatory disorders (fever), * spinal cord or cauda equina signs, * widespread neurological disorders affecting the tone of the limbs and neck muscles * underlying diseases, such as diabetes mellitus. * pace-maker * antibiotic prescription during the last 3 months * gastrointestinal surgery, * lower extremity injury (acute or overuse) that prevented them from participating in sports activities for at least one day in the previous 6 months.
Where this trial is running
Vienna, Wien
- UVienna — Vienna, Wien, Austria (Recruiting)
Study contacts
- Principal investigator: Giacomo Carta, PhD — University of Vienna
- Study coordinator: David Gomez Varela Senior Scientist, PhD
- Email: david.gomez.varela@univie.ac.at
- Phone: 1427755361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.