Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03000842
• Other study ID #: 5260/16
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: December 21, 2016
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• transcutaneous vagal nerve stimulation on
electrical current on positioned in the ear to estimate vagal branch of auricular nerve
• transcutaneous vagal nerve stimulation off
an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic control response to transcutaneous vagal nerve stimulation	sympathetic and parasympathetic response to non-invasive vagal nerve stimulation	40 minutes	No
Secondary	Blood pressure changes to transcutaneous vagal nerve stimulation	systemic response to non-invasive vagal nerve stimulation	40 minutes	No
Secondary	Heart Rate changes to transcutaneous vagal nerve stimulation	cardiac response to non-invasive vagal nerve stimulation	40 minutes	No