Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation and Its Underlying Mechanisms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Unpleasantness of pain
研究概览
简要总结
This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of muscarinic receptors. Also, this investigation will examine whether tVNS is associated with activation in brain areas, involved in processing of thermal pain stimuli and emotional and vegetative modulation of thermal pain in subjects who will respond with antinociceptive reaction to tVNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Real tVNS will be applied using pre-defined characteristics of tVNS device to cymba conchae of the auricle, sham procedure will be the same, however applied to tubule of the auricle
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers aged 18-45 years old, who have given informed consent
- •at least two days free from consume of recreational drugs
- •no local infection at the site of tVNS and pain stimulation
排除标准
- •psychiatric disorders
- •abnormal skin conditions (infection, scars, psoriasis, eczema) at the site of tVNS
- •contra-indications for MRI (e.g. claustrophobia, pregnancy, tattoos, metallic implants)
- •history of coronary heart disease, cardiac arrhythmia, glaucoma, allergy to sulphates
结局指标
主要结局
Unpleasantness of pain
时间窗: Continuously 5 minutes during the experimental heat pain stimulation
perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain).
次要结局
- Heart rate(Continuously 5 minutes during the experimental heat pain stimulation)
- Blood pressure(4 times during 5 minutes of the experimental heat pain stimulation)