Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

Not Applicable

• Conditions: Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects
• Interventions: Device: PrimeStim

• Registration Number: NCT02139293
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05
• Study Start: 2018-01
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• men and women aged 20 to 50 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
auricular vagus nerve stimulation	PrimeStim	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.

Primary Outcome Measures

Name	Time	Method
change in heart rate variability (HRV) related to stimulation site in the auricle	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles	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.
change in local blood perfusion index (BPI) related to stimulation site in the auricle	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles	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.

Secondary Outcome Measures

Name	Time	Method
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	Local BPI is assessed using optical sensors on the foot and the finger of participants.; Changes in mean value of BPI are analyzed using statistical tests.
Changes of C reactive protein- and leukocyte-concentration in serum	at screening and at the last day of intervention
Tolerance of stimulation	at each day of intervention at the stimulation cycles	Tolerance of stimulation is assessed by free survey.
Perception of Stimulation	at each day of intervention at the stiumulation cycles	Perception of stimulation is assessed by free survey.
Changes in blood pressure	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles	Blood pressure is continuously measured using inflatable finger cuffs.
Adverse effects of stimulation	within 4 days of intervention
Changes in respiratory activity	within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles	Respiratory activity is monitored using a respiratory belt.
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
Changes in foot skin temperature	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

Trial Locations

Locations (1)

University Clinic for Surgery, Department of Transplantation, Medical University Vienna; 🇦🇹 Vienna, Austria