Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Skin temperature changes
研究概览
简要总结
While invasive vagal stimulation has proven its therapeutic effectiveness over the past 20 years, particularly in the treatment of epilepsy or depression, its implementation is hampered by the high cost, high technicality and sometimes significant side effects. Non-invasive vagal stimulation, most often electric, is a less expensive therapeutic alternative and easier to implement, although the level of evidence is lower than that of invasive stimulation.
Some so-called traditional therapies, such as acupuncture, also stimulate certain parts of the ear by mechanical means, most often by puncturing the ear or the concha. In these traditional therapies, more than one hundred stimulation points have been described, each precisely positioned according to an empirical topography.
However, electrical non-invasive stimulation recognizes only three areas of interest on the ear, which are the areas of sensitive innervation, namely the afferences of the vagus nerve in the concha, which is the only one used in practice, the large occipital nerve on the lobe and part of the helix, and the auriculotemporal nerve on the rest of the auricular flag.
In this study, we would like to explore the justification for the topographic precision, adopted by traditional therapies, for non-invasive vagal stimulation on the concha.
详细描述
Main objective: to measure the physiological impact of two auricular stimuli on the same innervation territory but with opposite actions according to traditional therapies.
An identical physiological response on both stimulation points would be an argument against the topographical precision adopted by traditional therapies; conversely, a different physiological response would suggest the existence of a somatotopy nestled in the same innervation territory.
Secondary objectives:
- Determine, by sinus variability analysis, the intensity of the sympathetic and parasympathetic cardiac response of mechanical stimulation of the ear concha.
- Determine the existence of a blockage of the sympathetic reaction on cutaneous vasoconstriction after mechanical stimulation of the ear concha.
- Measure the relationship between sinus variability and paradoxical skin vasodilation after exposure to cold, as considered in the protocol.
To explore the justification for the topographical precision adopted by traditional therapies, we designed an experiment that consists of studying the autonomous, sympathetic and parasympathetic response to two stimuli performed over two different times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, male and female, aged 18 to 60 years
- •BMI (Body mass index) <=30
- •Not participating in another clinical study with an investigational product
排除标准
- •Drug treatment for cardiological, neurological or anticoagulant purposes
- •History of diabetes, known neuropathy, high blood pressure, heart rhythm disorders, syncope or palpitation
- •Known cryoglobulinemia
- •Subject with Raynaud's syndrome
- •Intra-auricular device of the piercing type,
- •Psychoactive substance use, excessive alcohol consumption (>2 units per day chronically or >6 units per day recreationally) and tobacco (>5 cigarettes per day)
- •Subject unable to read French
- •Subject covered by Articles L1121-5 to 1121-8 of the Public Health Code, namely:
- •Pregnant, postpartum and breastfeeding women
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons undergoing psychiatric care under Articles L3112-1 and L3113-1 who are not covered by the provisions of Article L1121-8
- •Persons of full age who are subject to a legal protection measure or who are unable to express their consent
结局指标
主要结局
Skin temperature changes
时间窗: 20 minutes
measured by thermocouples placed on the following fingers: thumb, middle finger and ear of the right hand. The values and times of the minimum and maximum temperatures (latency and amplitude of (CIVD) Cold-Induced VasoDilatation waves) are measured
次要结局
- Pain reported by the participant(20 minutes)