Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

Medical University of Vienna

Status: Unknown

Conditions: Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects

Treatments: Device: PrimeStim

Study type: Interventional

Funder types: Other

Identifiers

NCT02139293

PS 02/2014

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

auricular vagus nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: PrimeStim