Balance, Sensory Modulation, and Autonomic Response to Different Dosages of Non-invasive Mechanical Vagal Stimulation in Healthy Adults

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The vagus nerve (VN) plays a crucial role in regulating vital functions (heart rate, blood pressure, digestion, and immune response) and maintaining communication between internal organs and the brain. Recent studies have highlighted the therapeutic potential of VN stimulation (VNS) in treating various conditions such as drug-resistant epilepsy, postural control deficit, COVID-19 infection, chronic pain, and intestinal disorders. In addition, there is growing evidence that the molecules released by the VN neurons affect the function of the gut microbiota and that the molecules released by the bacteria in our gut affect the activity of the VN neurons. In particular, Dr. Giacomo Carta (the leader of this study) has shown how painless neck movements, i.e. mechanical VNS (mVNS), can be applied without adverse effects, representing a potential alternative to invasive methods commonly used today. To further investigate the impact of this novel mVNS, this study aims to evaluate the changes induced by three mVNS protocols on physiological parameters such as resting heart rate, and Heart Rate Variability (HRV) at rest, balance in standing, the perceived intensity of mechanical stimuli using the established clinical method of QST (quantitative sensory testing), fecal transit speed, and the molecular composition of stool (for this, stool samples are analyzed). In particular, stool analysis is very relevant for understanding normal digestion. The present research aims to define the optimal intensity of mVNS and to investigate the therapeutic potential of VNS in the treatment of autonomic dysfunction (such as too low or too high heart rate, too low or too fast digestion, throbbing headaches), as well as falls prevention and pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• agreement to participate by signing the informed consent form, being 18-60 years old, and sober

Locations
Other Locations
Austria
UVienna
RECRUITING
Vienna
Contact Information
Primary
David Gomez Varela Senior Scientist, PhD
david.gomez.varela@univie.ac.at
1427755361
Backup
Giacomo Carta, PhD
giacomo.carta@univie.ac.at
1427755318
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 128
Treatments
Experimental: mechanical Vagus Nerve Stimulation (Low Intensity)
4 minutes of mechanical vagal stimulation (2 minutes on each side) administered only once along the entire experiment
Experimental: mechanical Vagus Nerve Stimulation (Intermediate Intensity)
12 minutes of mechanical vagal stimulation(3 sessions of 2 minutes of stimulation, with 2 minutes of rest for each side) administered only once along the entire experiment
Experimental: mechanical Vagus Nerve Stimulation (High Intensity)
16 minutes of mechanical vagal stimulation (8 minutes on each side) administered only once along the entire experiment
Sham_comparator: Sham Vagus Nerve Stimulation
Participants will be treated with a fake vagus stimulation not able to stretch the vagus nerve
Related Therapeutic Areas
Sponsors
Leads: University of Vienna

This content was sourced from clinicaltrials.gov