Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systolic and diastolic Blood Pressure:
研究概览
简要总结
The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). The investigators hypothesized that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.
详细描述
The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). We hypothesize that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.A total sample of forty participants (N = 40; mean age 26.6 ± 6.7 years) were recruited for participation in the study. Prior to entering the study, all participants received information about the study and signed a consent form to participate. The study subjects were divided into two equally distributed groups (A: NESA = 20; B: Placebo = 20) and were blinded to the study group allocation. Participants in the placebo group underwent the same procedural phases as those in the intervention group. However, for the placebo group, the device was set to deliver a low-intensity current below the sensory threshold, effectively rendering it inactive from the participants' perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Age between: 18-55 years, both sexes.
排除标准
- •Cardiovascular disease.
- •Specific pharmacology.
- •Hypertension.
- •Diabetes.
- •Systemic diseases.
研究组 & 干预措施
Placebo
The placebo group followed the same procedure, except that no current was applied during their 20-minute session.
干预措施: Placebo (Other)
Experimental
The intervention in the study involves a unique application of 20min of NESA microcurrents
During the intervention, patients were seated comfortably on a sofa with their backs supported. NESA, a portable, noninvasive neuromodulation device, delivered low-frequency (1.3-14.28 Hz), low-intensity (0.1-0.9 mA), low-voltage (±3 V) microcurrents through 24 electrodes placed on the distal nerve endings of the wrists and ankles (six electrodes per limb). Direct stimulation of the autonomic nervous system was achieved using program 7 of the device with a directional electrode placed at the level of the C7 spinous process. This configuration established a circulating bioelectric circuit within the body, stimulating the autonomic nervous system below the patient's sensory threshold
干预措施: Non-Invasive neuromodulation (Device)
结局指标
主要结局
Systolic and diastolic Blood Pressure:
时间窗: before the intervention, and 10 minutes after the intervention
The pressure in the arteries during the contraction of the heart muscle. Measured with sphingomanometer.
Heart rate
时间窗: Before the intervention, and 10 minutes after the intervention
Hearbears per minute
次要结局
- Ultrasonographic variables: Cross-sectional area of the jugular vein(Before the intervention, and 10 minutes after the intervention)
- Ultrasonographic variables:Cross-sectional area of the common carotid(Before the intervention, and 10 minutes after the intervention)
- Ultrasonographic variables:Thickness of the common carotid(Before the intervention, and 10 minutes after the intervention)
- Ultrasonographic variables:Peak systolic velocity.(Before the intervention, and 10 minutes after the intervention)
- Cortisol measurement(Before the intervention, and 10 minutes after the intervention)
研究者
Vanesa Abuín
Associated Professor
Universidad Europea de Madrid
