Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change in heart rate variability (HRV) related to stimulation site in the auricle
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women aged 20 to 50 years
排除标准
- •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
研究组 & 干预措施
auricular vagus nerve stimulation
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.
干预措施: PrimeStim (Device)
结局指标
主要结局
change in heart rate variability (HRV) related to stimulation site in the auricle
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- Perception of Stimulation(at each day of intervention at the stiumulation cycles)
- Changes in blood pressure(within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles)
- 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)
- 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)
研究者
Dr. Jozsef Constantin Széles
Dr.med.
Medical University of Vienna