Non-invasive Modulation of Autonomic Cardiac Nervous System

Heart Rate Variability Clinical Trial

— MSNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057508
• Other study ID #: TFE_201904_097
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Université Catholique de Louvain
• Contact: Anaïs Gauthey, MD
• Phone: 027682888
• Email: anais.gauthey[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers

• >18 years old

Exclusion Criteria:

• pregnancy and breastfeeding

• smoke

• alcool/energy drinks/coffee consumption, exertion 24h before the participation

Related Conditions & MeSH terms

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

Intervention

Other:
• Modulation of muscle sympathetic nerve activity
Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Profile of response of MSNA during prolonged breath hold	Modulation of MSNA activity during repetitive prolonged breath hold	4hours
Primary	Heart rate variability modulation	Modulation of heart rate variability assessed through analysis of MSNA signal	4 hours
Secondary	Non-invasive vagus nerve stimulation	Modulation of parasympathetic tone based on two different frequencies stimulation	4hours
Secondary	Profile of response for MSNA	To describe positive and negative patterns of MSNA response	4 hours