Non-invasive Modulation of Autonomic Cardiac Nervous System (MSNA)

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

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

Study Overview

• Status: Unknown
• Conditions: Heart Rate Variability; Autonomic Nervous System; Muscle Sympathetic Nerve Activity
• Intervention / Treatment: Other: Modulation of muscle sympathetic nerve activity

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anaïs Gauthey, MD; Phone Number: 0032 027682888; Email: anais.gauthey@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasme University Hospital
    • Contact: Anaïs Gauthey, MD; Phone Number: 0032 025555919; Email: anais.gauthey@uclouvain.be
    • Contact: SRB Service de Recherche Biomédicale; Phone Number: 0032 02 25 55 83 51; Email: Service.Rech-biomed@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers
• >18 years old

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stimulation protocol; Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order .	Other: Modulation of muscle sympathetic nerve activity; Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.
Sham Comparator: Sham stimulation protocol; Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order.	Other: Modulation of muscle sympathetic nerve activity; Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability modulation	Modulation of heart rate variability assessed through analysis of MSNA signal	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive vagus nerve stimulation	Modulation of parasympathetic tone based on two different frequencies stimulation	4hours
Profile of response for MSNA	To describe positive and negative patterns of MSNA response	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of response of MSNA during prolonged breath hold	Modulation of MSNA activity during repetitive prolonged breath hold	4hours

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Heart rate variability, MSNA, vagus nerve, sympathetic nervous system
• Other Study ID Numbers: TFE_201904_097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No