Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03000842

Enrollment

Registered

2016-12-22

Start date

2017-01-31

Completion date

2017-06-30

Last updated

2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

autonomic control, transcutaneous vagal nerve stimulation, transauricular vagal nerve stimulation

Brief 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

Interventions

DEVICEtranscutaneous vagal nerve stimulation on

electrical current on positioned in the ear to estimate vagal branch of auricular nerve

DEVICEtranscutaneous vagal nerve stimulation off

an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026