Effects of Transcranial Direct Current Stimulation on Primary Cortex and Prefrontal Dorsolateral Cortex in Pain Processing on Healthy Volunteers: A Triple Blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain pressure algometer temporal summation
研究概览
简要总结
The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40 years
- •Comprehension of the study tasks
排除标准
- •Presence of pain in the previous 6 months
- •Altered sensitivity in the tested regions
- •Intolerance to electrotherapy
- •Presence of pacemakers or any other implanted device
- •Ulcers or scars in the skin at the location of the electrodes
- •Treatment with direct current stimulation within one week
- •Pregnancy
- •Frequent headaches
- •History of neuromuscular disease
- •Previous clinical history of cervical surgery
- •Injuries or surgery affecting the upper limb
- •diabetes mellitus
- •Cardiovascular diseases
- •Oncological diseases
- •Consumption of analgesic drugs 7 days before the study
研究组 & 干预措施
Sham stimulation
A 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp.
干预措施: Transcranial direct current stimulation (Device)
M1 stimulation
A 20 minutes 1mA direct current stimulation over left M1.
干预措施: Transcranial direct current stimulation (Device)
M1+DLPFC stimulation
A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC.
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
Pain pressure algometer temporal summation
时间窗: Pre-intervention and immediately after treatment
Change in pain perceived between the first and tenth painful pressure stimulus
Conditioned Pain Modulation
时间窗: Pre-intervention and immediately after treatment
Pain pressure threshold change after a painful ischemic stimulus
次要结局
- Neural mechanosensitivity(Pre-intervention and immediately after treatment)
- Pain pressure threshold(Pre-intervention and immediately after treatment)
- Pain pressure tolerance(Pre-intervention and immediately after treatment)
- Cold hyperalgesia with a cold pack(Pre-intervention and immediately after treatment)
- Isometric grip strength(Pre-intervention and immediately after treatment)
研究者
Josue Fernandez Carnero
Associate Professor
Universidad Rey Juan Carlos