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Non-invasive Modulation of Autonomic Cardiac Nervous System

Effects of Non Invasive Vagus Nerve Stimulation on Heart Rate Variability in Healthy Subjects and on Muscle Sympathetic Nerve Activity

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04057508
Acronym
MSNA
Enrollment
60
Registered
2019-08-15
Start date
2019-06-19
Completion date
2019-12-31
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System, Heart Rate Variability, Muscle Sympathetic Nerve Activity

Keywords

Heart rate variability, MSNA, vagus nerve, sympathetic nervous system

Brief summary

To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.

Detailed description

First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve. Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration. Continuous recording of the following parameters: * non-invasive arterial blood pressure * R-R interval * electrocardiogram * MSNA activity * respiratory curve signal * respiratory rate, oxygen saturation

Interventions

OTHERModulation of muscle sympathetic nerve activity

Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.

Sponsors

Erasme University Hospital
CollaboratorOTHER
Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Investigators are double-blinded for both experimental procedures and data analyzes. Volunteers are blinded to the site of stimulation.

Intervention model description

Randomized, controlled, double-blind, cross-over study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers * \>18 years old

Exclusion criteria

* pregnancy and breastfeeding * smoke * alcool/energy drinks/coffee consumption, exertion 24h before the participation

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability modulation4 hoursModulation of heart rate variability assessed through analysis of MSNA signal

Secondary

MeasureTime frameDescription
Non-invasive vagus nerve stimulation4hoursModulation of parasympathetic tone based on two different frequencies stimulation
Profile of response for MSNA4 hoursTo describe positive and negative patterns of MSNA response

Other

MeasureTime frameDescription
Profile of response of MSNA during prolonged breath hold4hoursModulation of MSNA activity during repetitive prolonged breath hold

Countries

Belgium

Contacts

Primary ContactAnaïs Gauthey, MD
anais.gauthey@uclouvain.be027682888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026