Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation, Muscular Perfusion and Autonomic Response in Healthy Subjects: a Randomized, Crossover, Sham Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Cortical Activation
研究概览
简要总结
This randomized, crossover sham controlled trial with sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.
Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out.
The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.
详细描述
In recent years, there are growing evidence that many diseases such as chronic pain and psychiatric disorders can be managed with non-pharmacological techniques. The possibility of inducing central neuroplastic responses through transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) has been widely studied, as well as peripheral stimulation techniques such electroacupuncture (EA) and intramuscular stimulation (IMS). However, there are few studies on physiological mechanisms, indications and limitations of each technique.
Thus, this randomized, crossover sham controlled trial, where sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.
Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out.
The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subjects
- •right handed
- •basic education
排除标准
- •contraindication to infrared technology NIRS
- •brain stimulator device
- •drug and alcohol abuse
- •chronic disease (any);
- •chronic pain condition
- •tobacco use
- •psychiatric disorders
- •Beck Depression Inventory higher then score 12
- •psychotropic drugs
- •use of pain-killers or anti-inflammatories 12h previous experiment
研究组 & 干预措施
Active Group
Needle electrical stimulation of accessory spinal nerve
干预措施: Electrical Stimulation (Procedure)
Sham Group
Needle of accessory spinal nerve without electrical stimulation
干预措施: Electrical Stimulation (Procedure)
结局指标
主要结局
Cortical Activation
时间窗: 12 minutes
The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)
次要结局
- Blood pressure(20 minutes)
- Cardiac frequency(20 minutes)
- Muscular perfusion(12 minutes)
- Oxygen saturation(20 minutes)
研究者
Wolnei Caumo
Surgery Department Professor, School of Medicine UFRGS - MD. PhD.
Hospital de Clinicas de Porto Alegre