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Balance, Autonomic Response, and Sensory Modulation to Dosage of Mechanical Vagal Stimulation in Healthy Adults

NCT ID: NCT06541808

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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mechanical VNs in humans, induced by a combination of non-painful physiological neck movements, effectively reduces the HR at rest in humans, without any side effects in the short- and long-term. Indeed, HR reduction is a proxy for the VN increased activity among healthy subjects and patients with systemic diseases or autonomic diseases. Mechanical VNs had been successfully adopted in two clinical trials among chronic pain patients (NCT05345496, NCT05360589), but due to the early stage of these new VNs and the clear advantages of this method, studies refining the stimulation protocol are suitable. Thus, the study aims to investigate the possible dose-dependent effects of mVNs on different physiological parameters in humans. 3 protocols of mVNs will be compared consisting of (1) 4 minutes (2 minutes on each side); (2) 12 minutes (3 sessions of 2 minutes of stimulation, with 2 minutes of rest for each side); (3) 16 minutes (8 minutes on each side). The following outcomes will be assessed before and after the stimulation: HR at rest, HRV, balance on standing, perceived intensity and modulation of mechanical stimuli on the skin of the forehead, and the abdomen, gastrointestinal transit, and a fecal sample from the closest intestinal emptying. A total sample of at least 96 healthy subjects (48 females) aged between 18 and 60 are expected to participate. The bidirectional communication between internal organs and the brain via the VN is a well-established scientific fact. Indeed, VNs has beneficial effects on manifold pathological conditions in humans. However, easy-to-apply, non-invasive, and effective VNs methods and standardized protocols are lacking. The here proposed project aims at refining and critically assessing mVNs methods - a prerequisite for exploring the clinical utility of mVNs and fostering its therapeutic potential given the fundamental role of the VN in regulating health and disease. Results obtained from this project will provide data on mVNs on gut microbiota dynamics and the potential benefits for pain modulation, equilibrium impairments, and gastrointestinal dysfunctions.

Conditions

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Vagus Nerve Autonomic Disorder Heart Rate Pain Equilibrium; Disorder, Labyrinth Microbial Colonization

Keywords

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Non-invasive Vagus Nerve stimulation Heart Rate Equilibrium Pain modulation Gut microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mechanical Vagus Nerve Stimulation (Low Intensity)

4 minutes of mechanical vagal stimulation (2 minutes on each side) administered only once along the entire experiment

Group Type EXPERIMENTAL

mechanical Vagus Nerve Stimulation (Low Intensity)

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

mechanical Vagus Nerve Stimulation (Intermediate Intensity)

Intervention Type OTHER

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.

mechanical Vagus Nerve Stimulation (High Intensity)

16 minutes of mechanical vagal stimulation (8 minutes on each side) administered only once along the entire experiment

Group Type EXPERIMENTAL

mechanical Vagus Nerve Stimulation (High Intensity)

Intervention Type OTHER

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.

Sham Vagus Nerve Stimulation

Participants will be treated with a fake vagus stimulation not able to stretch the vagus nerve

Group Type SHAM_COMPARATOR

Sham mechanical Vagus Nerve Stimulation

Intervention Type OTHER

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

Interventions

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mechanical Vagus Nerve Stimulation (Low Intensity)

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.

Intervention Type OTHER

mechanical Vagus Nerve Stimulation (Intermediate Intensity)

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.

Intervention Type OTHER

mechanical Vagus Nerve Stimulation (High Intensity)

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.

Intervention Type OTHER

Sham mechanical Vagus Nerve Stimulation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Giacomo Carta

Postdoc PhD Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giacomo Carta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Locations

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UVienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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David Gomez Varela Senior Scientist, PhD

Role: CONTACT

Phone: 1427755361

Email: [email protected]

Giacomo Carta, PhD

Role: CONTACT

Phone: 1427755318

Email: [email protected]

Facility Contacts

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David Gomez Varela, PhD

Role: primary

Ranjith Kumar Ravi Kumar, PhD

Role: backup

Other Identifiers

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EK Nr: 1349/2024

Identifier Type: -

Identifier Source: org_study_id