An interventional study of PrimeStim in Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science
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.
Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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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.
Device: PrimeStim
Intermittent auricular vagus nerve stimulation at different ear points
change in heart rate variability (HRV) related to stimulation site in the auricle
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.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
change in local blood perfusion index (BPI) related to stimulation site in the auricle
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.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Change of local BPI in upper and lower extremities
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.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in blood pressure
Blood pressure is continuously measured using inflatable finger cuffs.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in respiratory activity
Respiratory activity is monitored using a respiratory belt.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in oxygen saturation of the toe
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in partial transcutaneous oxygen pressure of the forefoot
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in foot skin temperature
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes of C reactive protein- and leukocyte-concentration in serum
Time frame: at screening and at the last day of intervention
Tolerance of stimulation
Tolerance of stimulation is assessed by free survey.
Time frame: at each day of intervention at the stimulation cycles
Perception of Stimulation
Perception of stimulation is assessed by free survey.
Time frame: at each day of intervention at the stiumulation cycles
Adverse effects of stimulation
Time frame: within 4 days of intervention
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna