Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541808
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Balance Autonomic Response and Sensory Modulation to Dosage of Mechanical Vagal Stimulation in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Balance Sensory Modulation and Autonomic Response to Different Dosages of Non-invasive Mechanical Vagal Stimulation in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BARVANS
Brief 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 ie 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:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None