Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

NCT02139293 | Unknown

• 1 other identifier: PS 02/2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects

Keywords

vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change of local BPI in upper and lower extremities

  within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles

• Changes in blood pressure

  within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles

• Changes in respiratory activity

  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

Study Arms (1)

auricular vagus nerve stimulation

EXPERIMENTAL

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

Interventions

PrimeStim DEVICE

Intermittent auricular vagus nerve stimulation at different ear points

auricular vagus nerve stimulation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• men and women aged 20 to 50 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Vienna University of Technology: collaborator

Study Sites (1)

University Clinic for Surgery, Department of Transplantation, Medical University Vienna

Vienna, 1090, Austria

Location

Study Officials

• Jozsef C Széles, Dr.med.

  University Clinic for Surgery, Department of Transplantation, Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jozsef C Széles, Dr.med.

CONTACT

+4367687832013; jozsef.szeles@meduniwien.ac.at

Stefan Kampusch, MSc

CONTACT

stefan.kampusch@tuwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

AU (1)