Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study

The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on cardiovascular parameters and sympathovagal balance in healthy subjects. It is investigated if auricular vagal nerve stimulation affects heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the site of stimulation in the auricle, whereas four distinct stimulation points are tested.

Study Overview

• Status: Unknown
• Conditions: Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects
• Intervention / Treatment: Device: PrimeStim

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jozsef C Széles, Dr.med.; Phone Number: +4367687832013; Email: jozsef.szeles@meduniwien.ac.at
• Study Contact Backup: Name: Stefan Kampusch, MSc; Email: stefan.kampusch@tuwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • University Clinic for Surgery, Department of Transplantation, Medical University Vienna
    • Contact: Jozsef C Széles, Dr.med.; Phone Number: +4367687832013; Email: jozsef.szeles@meduniwien.ac.at
    • Principal Investigator: Jozsef C Széles, Dr.med.
    • Sub-Investigator: Eugenijus Kaniusas, Prof.
    • Sub-Investigator: Stefan Kampusch, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• men and women aged 20 to 50 years

Exclusion Criteria:

• participation in a clinical trial in the last 5 weeks
• diseases which may affect the autonomous nervous system (e.g., diabetes mellitus)
• confounding medical treatment with known effects on the autonomous nervous system (e.g., beta blocker)
• drug abuse
• active implanted devices
• pregnancy or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: auricular vagus nerve stimulation; Study participants (healthy) are treated with auricular vagus nerve stimulation using five needle electrodes connected to an electrical stimulation device (PrimeStim). After acclimatization the stimulation is turned on for 20 minutes followed by 20 minutes of paused stimulation, 20 minutes of stimulation, and 10 minutes paused stimulation. This intervention is repeated on four consecutive days, whereas at each intervention only one of the four stimulation points (and one fixed reference point) is stimulated. Needle electrodes are applied at each study visit. Stimulation points in the auricle are stimulated in random order. One stimulation pattern is tested. Stimulation amplitudes are adjusted with respect to a distinct but comfortable sensation at the auricle. During the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature.

Device: PrimeStim; Intermittent auricular vagus nerve stimulation at different ear points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in heart rate variability (HRV) related to stimulation site in the auricle	Heart rate variability will be assessed as, e.g., standard deviation in heart rate over a time window of 5 minutes (2.5 minutes overlap), total power or low to high frequency power. Changes in assessed heart rate variability parameters will be assessed and compared between subjects with respect to stimulation site using statistical tests.	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
change in local blood perfusion index (BPI) related to stimulation site in the auricle	Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion. Changes in mean value and standard deviation of local blood perfusion index will be assessed and compared between subjects with respect to stimulation site using statistical tests.	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of local BPI in upper and lower extremities	Local BPI is assessed using optical sensors on the foot and the finger of participants. Changes in mean value of BPI are analyzed using statistical tests.	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in blood pressure	Blood pressure is continuously measured using inflatable finger cuffs.	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in respiratory activity	Respiratory activity is monitored using a respiratory belt.	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in oxygen saturation of the toe		within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in partial transcutaneous oxygen pressure of the forefoot		within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in foot skin temperature		within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes of C reactive protein- and leukocyte-concentration in serum		at screening and at the last day of intervention
Tolerance of stimulation	Tolerance of stimulation is assessed by free survey.	at each day of intervention at the stimulation cycles
Perception of Stimulation	Perception of stimulation is assessed by free survey.	at each day of intervention at the stiumulation cycles
Adverse effects of stimulation		within 4 days of intervention

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Vienna University of Technology
• Investigators: Principal Investigator: Jozsef C Széles, Dr.med., University Clinic for Surgery, Department of Transplantation, Medical University Vienna

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
• Other Study ID Numbers: PS 02/2014

Drug and device information, study documents

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