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
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in heat-pain threshold with pain score
研究概览
简要总结
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.
详细描述
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male 18-40 years old
- •Without medication
- •Sign the informed consent
排除标准
- •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
研究组 & 干预措施
Melatonin
0,25mg/Kg sl before tDCS
干预措施: Melatonin (Drug)
tDCS
Transcranial direct current stimulation once time. Dose 2 mA, 20 seconds.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Change from baseline in heat-pain threshold with pain score
时间窗: Baseline, one week
Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)
次要结局
- Change from Baseline from Catastrophizing Scale(Baseline, one week)
- Change from baseline Inventory of Coping(Baseline, one week)
- Change from baseline of cortical excitability(Baseline, one week)
- Change from baseline Brain-Derived neurotrophic factor (BDNF)(Baseline, one week)
- Change from baseline Inventory of state-trait anxiety Scale(Baseline, one week)