Balance, Autonomic Response, and Sensory Modulation to Dosage of Mechanical Vagal Stimulation in Healthy Adults
Balance, Sensory Modulation, and Autonomic Response to Different Dosages of Non-invasive Mechanical Vagal Stimulation in Healthy Adults
University of Vienna
128 participants
Dec 2, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- agreement to participate by signing the informed consent form, being 18-60 years old, and sober
Exclusion Criteria11
- 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.
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Interventions
The stimulation consists of a combination of normal neck movements, performed in a comfortable supine position, which can selectively stimulate the VN. In particular. The participant will be stimulated supine on a comfortable massage/treatment bed with the experimenter standing at the cranial short side of the bed. All the neck movements will be gently performed with a combination of upper cervical flexion and contralateral lateral flexion to load the intracranial portion of the vagus nerve. The ipsilateral neck rotation will be combined to load the cervical tract of the nerve. Keeping the participant's head in the final movements combination the upper abdomen will be gently moved caudally to load the thoracic tract and intermittent gentle impulses 1 each second will be administered. The stimulation will be provided for 2 consecutive minutes for each side, only once for the experiment duration.
The stimulation consists of a combination of normal neck movements, performed in a comfortable supine position, which can selectively stimulate the VN. In particular. The participant will be stimulated supine on a comfortable massage/treatment bed with the experimenter standing at the cranial short side of the bed. All the neck movements will be gently performed with a combination of upper cervical flexion and contralateral lateral flexion to load the intracranial portion of the vagus nerve. The ipsilateral neck rotation will be combined to load the cervical tract of the nerve. Keeping the participant's head in the final movements combination the upper abdomen will be gently moved caudally to load the thoracic tract and intermittent gentle impulses 1 each second will be administered. The stimulation will be provided for 3 sessions of 2 minutes, with 2 minutes of rest for each side. stimulation will be provided only once for the experiment duration.
The stimulation consists of a combination of normal neck movements, performed in a comfortable supine position, which can selectively stimulate the VN. In particular. The participant will be stimulated supine on a comfortable massage/treatment bed with the experimenter standing at the cranial short side of the bed. All the neck movements will be gently performed with a combination of upper cervical flexion and contralateral lateral flexion to load the intracranial portion of the vagus nerve. The ipsilateral neck rotation will be combined to load the cervical tract of the nerve. Keeping the participant's head in the final movements combination the upper abdomen will be gently moved caudally to load the thoracic tract and intermittent gentle impulses 1 each second will be administered. The stimulation will be provided for 8 consecutive minutes for each side, only once for the experiment duration.
Participants will be treated with a fake vagus stimulation by letting the operator hold the neck of the participant in one hand and placing the other hand on the abdomen without any stretch on the vagus nerve
Locations(1)
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NCT06541808