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临床试验/NCT06320171
NCT06320171已完成不适用

Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System

Universidad Europea de Madrid1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

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

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

Placebo Comparator

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

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

发起方
Universidad Europea de Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanesa Abuín

Associated Professor

Universidad Europea de Madrid

研究点 (1)

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