Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

December 21, 2016 updated by: Instituto de Cardiologia do Rio Grande do Sul

Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects

The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct stimulation of the vagal nerve. However, there are still no strong evidences about it actions regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at rest and after orthostatic position

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Normotensive group Inclusion Criteria:

  • healthy volunteers
  • sign the consent term

Normotensive group Exclusion Criteria:

  • smokers
  • alcoholism
  • drug treatment
  • skin lesion in the ear region
  • chronic or acute diseases
  • pregnancy
  • be participating in another research protocol
  • high performance athletes
  • recent surgery
  • vaso-vagal syndrome

Hypertensive group Inclusion Criteria:

  • hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or
  • ambulatory blood pressure monitoring (ABPM) >130/85
  • sign the consent term

Hypertensive group Exclusion Criteria:

  • smokers
  • alcoholism
  • beta-blockers treatment
  • skin lesion in the ear region
  • associated diseases
  • pregnancy
  • be participating in another research protocol
  • high performance athletes
  • recent surgery
  • vaso-vagal syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Subjects
transcutaneous vagal nerve stimulation
Device: transcutaneous vagal nerve stimulation on
electrical current on positioned in the ear to estimate vagal branch of auricular nerve
Device: transcutaneous vagal nerve stimulation off
an electrical current off positioned in the ear to estimate vagal branch of auricular nerve
Experimental: Hypertensive Subjects
transcutaneous vagal nerve stimulation
Device: transcutaneous vagal nerve stimulation on
electrical current on positioned in the ear to estimate vagal branch of auricular nerve
Device: transcutaneous vagal nerve stimulation off
an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic control response to transcutaneous vagal nerve stimulation
Time Frame: 40 minutes
sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure changes to transcutaneous vagal nerve stimulation
Time Frame: 40 minutes
systemic response to non-invasive vagal nerve stimulation
40 minutes
Heart Rate changes to transcutaneous vagal nerve stimulation
Time Frame: 40 minutes
cardiac response to non-invasive vagal nerve stimulation
40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 22, 2016

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5260/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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