Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.
Effect of Melatonin and Transcranial Direct Current Stimulation (tDCS) on Neuroplasticity and the Heat-pain Detection Threshold in Healthy Subjects:Randomized, Double-blind,Crossover Trial
Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is associated with a wide range of diseases and their social consequences is a public health problem.
With the progress of neuroscience and studies on the plasticity of the central nervous system, it has been provided a better understanding of the neurobiological mechanisms of pain.
The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both in physiological and pathological situations, with modulating effects on the process of nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and GABAergic, exerting anti-inflammatory action, analgesic activity among others.
The advent of neuromodulation techniques such as transcranial direct current stimulation (tDCS), which promote changes in neuronal activity and signaling to be effective in conditions of chronic pain by attenuating changes in cortical excitability.
There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus, considering the potential for each isolated intervention and the lack of knowledge of their combined effect, the authors propose the present study to investigate the effect of this combination on the heat-pain detection threshold and the neuroplasticity in the healthy subjects.
研究概览
详细说明
The methods are according to the CONSORT guidelines.
Heat pain threshold and tolerance : Quantitative Sensory Testing (QST) will be used on a computer Peltier-based device thermode.
Conditioned Pain Modulation (CPM)-task: Immerssing the non-dominant hand cold water for 1 minute.
Serum Brain Derived Neurotrophic Factor (BDNF).
Transcranial Magnetic Stimulation (TMS) assessment: motor threshold, motor evoked potential, Short intracortical inhibition and intracortical facilitation.
Statistical analyses: Descriptive statistics, Linear and multiple regression analysis, performed with SPSS version18.0.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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RS
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Porto Alegre、RS、巴西、900035-903
- 招聘中
- Hospital de Clinicas de Porto Alegre
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接触：
- Wolnei Caumo
- 电话号码：555133590083
- 邮箱：caumo@cpovo.net
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副研究员：
- Nadia Jardim, MD, Msc
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male 18-40 years old
- Healthy
- Without medication
- Sign the informed consent
Exclusion Criteria:
- Patients who did not understand the Portuguese
- Acute or chronic pain conditions
- Medical or psychiatric disorders
- History of alcohol or substance abuse
- Neurological disorder
- Use of medications affect in the central nervous system
- Traumatic brain injury
- Neurosurgery
- Metallic implant in the brain
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Melatonin
0,25mg/Kg sl before tDCS
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实验性的：tDCS
Transcranial direct current stimulation once time.
Dose 2 mA, 20 seconds.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in heat-pain threshold with pain score
大体时间：Baseline, one week
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Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)
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Baseline, one week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline Brain-Derived neurotrophic factor (BDNF)
大体时间：Baseline, one week
|
Baseline, one week
|
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Change from Baseline from Catastrophizing Scale
大体时间：Baseline, one week
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Baseline, one week
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Change from baseline Inventory of state-trait anxiety Scale
大体时间：Baseline, one week
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Baseline, one week
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Change from baseline Inventory of Coping
大体时间：Baseline, one week
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Baseline, one week
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Change from baseline of cortical excitability
大体时间：Baseline, one week
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Transcranial Magnetic Stimulation (TMS) assessment motor threshold, motor-evoked potentials, silent period, intracortical inhibition and facilitation
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Baseline, one week
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合作者和调查者
调查人员
- 首席研究员：Wolnei Caumo、Hospital de Clinicas de Porto Alegre - UFRGS
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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