跳至主要内容
临床试验/NCT05230628
NCT05230628进行中(未招募)不适用

The Effectiveness of Transcutaneous Electrical Nerve Stimulation of the Auricular Branch of the Vagus Nerve in Loss Weight and Improving the Quality of Life in Patients With Obesity

National Medical Research Center for Therapy and Preventive Medicine2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2022年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
131
试验地点
2
主要终点
Percentage of body fat

研究概览

简要总结

Transcutaneous vagus nerve stimulation (TENS) involves stimulation of the left and/or right auricular branch of the vagus nerve with low-frequency electrical impulses. In recent years, the possibilities of using this technology in chronic conditions characterized by immune and metabolic dysregulation have been studied. The aim of this study is to investigate the effectiveness of TENS in reducing weight and improving quality of life in patients with various degrees of obesity.

详细描述

Obesity is one of the leading causes of disability and death worldwide. In 2016, more than 1.9 billion adults were overweight, according to the World Health Organization. According to current projections, by 2030, 60% of the world's population (that is, 3.3 billion people) may be overweight (2.2 billion) or obese (1.1 billion), if trends in obesity continue.

In 2021, the journal Nature Communications published data on the effectiveness of the use of an invasive device that stimulates the efferent fibers of the vagus nerve of the stomach with light fluxes and thereby reduces the severity of hunger. In addition, in small clinical trials in patients with depression and epilepsy treated with transcutaneous vagus nerve stimulation, this procedure has been shown to lead to significant weight loss.

Although the mechanisms are not fully understood, it is believed that a high-calorie diet contributes to the desensitization of the vagus afferent fibers to peripheral signals and leads to a decrease in the constitutive expression of orexigenic receptors and neuropeptides. Violation of signal transmission along the afferent fibers of the vagus nerve may be sufficient for the development of hyperphagia and obesity, and stimulation of the vagus nerve, respectively, can be used in the treatment of these conditions. Recent discoveries revealed a new and important role of the vagus nerve within a physiological mechanism that utilizes afferent and efferent signaling in controlling cytokine levels and inflammation - the inflammatory reflex.

Afferent vagus nerve projections to the GI tract and the hepatic portal system play a major role in communicating alterations in peripheral metabolic homeostasis, including changes in cholecystokinin, lipids, leptin, insulin and glucose levels to the brain. In a reflex manner, efferent vagus nerve innervations of the heart, liver and pancreas provide cardio-metabolic regulatory output. Cholecystokinin- and leptin-induced afferent vagus nerve activity importantly mediates satiety and regulates feeding behavior. Cholecystokinin, released as a result of intestinal lipid accumulation also causes activation of afferent signaling and subsequent efferent vagus nerve output to liver that suppresses hepatic gluconeogenesis.

Transcutaneous vagus nerve stimulation (TENS) involves the stimulation of the left and/or right auricular branch of the vagus nerve in the area of the cymba concha with low-frequency electrical impulses. The auricular branch of the vagus nerve runs superficially, which makes it a favorable target for non-invasive stimulation techniques to modulate vagal activity. It gained popularity due to minimal side effects and low cost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients with grade 1-2 nutritional obesity who are willing and able to give informed written consent to participate in the study, are on sinus rhythm and are not taking any antiarrhythmic drugs, including beta-blockers.

排除标准

  • •Cardiac arrhythmias: bradyarrhythmias, Atrioventricular blockades of any degree;
  • •Taking beta blockers;
  • •The endocrine nature of obesity;
  • •Expected technical difficulties when using the device on the part of the patient;
  • •Pregnant or plan on becoming pregnant or breastfeeding during the study period;
  • •Presence of an electrically, magnetically or mechanically activated implant, an intracerebral vascular clip, or any other electrically sensitive support system.

研究组 & 干预措施

Active TENS

Experimental

Active will be performed with using a TENS device with an ear clip attached to the tragus of the right ear (which is innervated by auricular branch of the vagus nerve) at 25 Hz, 200ms at a current just below discomfort threshold.

干预措施: Active TENS (Device)

Sham TENS

Sham Comparator

Sham TENS will be performed to the ear lobe, which is devoid of vagal innervation.

干预措施: Sham TENS (Device)

结局指标

主要结局

Percentage of body fat

时间窗: 6-month follow-up

It is calculated using the body composition analyzer "In Body 910" in dynamics (at the start and at the end of the trial).

Waist circumference

时间窗: 6-month follow-up

Waist circumference will be measured on bare skin midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape to the nearest 0.1 cm following the World Health Organization guideline. Measurement will be performed at the start and at the end of the trial.

Body Mass Index

时间窗: 6-month follow-up

BMI will be determined by the equation (kg/m2) in dynamics (at the start and at the end of the trial).

次要结局

  • Waist circumference/Hip circumference(6-month follow-up)
  • Percentage of Total Weight Loss(6-month follow-up)
  • Total Weight Loss(6-month follow-up)
  • Eating behavior questionnaire(6-month follow-up)
  • Adverse Events(6-month follow-up)
  • Lean Mass(6-month follow-up)
  • Hip circumference(6-month follow-up)
  • Health-related Quality of Life(6-month follow-up)
  • Adherence(6-month follow-up)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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