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临床试验/NCT02408237
NCT02408237已完成不适用

Development of Apparatus of Transcranial Direct Current Stimulation (tDCS) for Domiciliary Use

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Cortical excitability on the transcranial magnetic stimulation (TMS)

研究概览

简要总结

Neuromodulation is characterized as a technique whose principle neurostimulation to produce inhibition or cortical arousal. The tDCS (transcranial direct current stimulation) is a noninvasive brain stimulation method used to modulate cortical excitability using low intensity direct current (1-2mA) directed to the scalp via cathodes and anodes electrodes; the current reaches the cortex, producing hyperpolarization or depolarization of the axonal membrane potential. Evidence has shown that this method is presented as a technique that can alter cortical and subcortical neural networks. This technique has been used to treat psychiatric disorders such as depression, acute mania, bipolar affective disorder panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation after-stroke and pain syndromes such as neuropathic pain, migraine, pancreatitis chronic pain and fibromyalgia. It is low-cost technique, with virtually no side effects and carries the therapeutic effect by neuromodulatory pathways by distinct pathways activated by the drugs. In this scenario falls within the importance of developing devices for home use, inexpensive, and easy to use so as to maintain the benefits observed in previous studies. The tDCS is presented as a non-pharmacological option that may be offered in this context in society. It is noteworthy that, if the benefit is demonstrated, the impact will be of great importance to patients and to society, since these are focal techniques and low cost. Because they have no focal adverse effects of conventional drug treatments. Additionally, can be constituted as technical additive to pharmacotherapy in so much pain as in the treatment of other neuropsychiatric disorders. Therefore, further studies should be encouraged to increase knowledge of their effects and mechanisms involved. If the effectiveness of this method for home use is confirmed, the therapeutic impact will undoubtedly be of great importance. However, to make this project come true, the investigators depend on support for the development and validation of tDCS device for home use, so allowing the qualified knowledge can be applied to the clinical setting, as well as advance the development of this area of neuroscience in Brazil. Therefore, the aim of this study is to develop tDCS device for home use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
Triple (Participant, 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

入选标准

  • Men and women, aged between 18 and 40 years.
  • Higher education (college graduates in progress or completed).

排除标准

  • Subject left-handed.
  • History of neurological disease.
  • History of endocrine disease.
  • History of psychiatric disorder.
  • History of sleep disorders (apnea, hypersomnia, insomnia, sleepwalking ...).
  • Chronic pain.
  • Chronic inflammatory and oncological diseases.
  • Systemic arterial hypertension; ischemic heart disease.
  • Kidney and liver failure.
  • Regular use of steroids and non-steroids anti inflammatory, opioids and non-opioids, psychotropics, anticonvulsants, alpha and beta-blockers.
  • Regular use of drugs, alcohol and tobacco.
  • History of brain surgery, tumor, stroke or intracranial implantation of metal (or not implemented).
  • Subjects who do not understand Portuguese.
  • Body mass index greater than 29.9.

研究组 & 干预措施

tDCS Ambulatory & Sham

Active Comparator

Active tDCS Ambulatory: 1 mA of current of active tDCS applied for 20 minutes, single session of stimulation. Sham tDCS Ambulatory: applied for 20 minutes, single session of stimulation.

干预措施: Active tDCS Ambulatory (Device)

tDCS Ambulatory & Sham

Active Comparator

Active tDCS Ambulatory: 1 mA of current of active tDCS applied for 20 minutes, single session of stimulation. Sham tDCS Ambulatory: applied for 20 minutes, single session of stimulation.

干预措施: Sham tDCS Ambulatory (Device)

tDCS home use & Sham

Active Comparator

Active tDCS home use: 11 active tDCS sessions: single session in the hospital and the remaining 10 in the subject's home, with duration of each active tDCS session of 20 min. Sham tDCS home use: 11 sessions of tDCS: single session in the hospital and the remaining 10 in the subject's home, with duration of each sham tDCS session of 20 min.

干预措施: Active tDCS Home use (Device)

tDCS home use & Sham

Active Comparator

Active tDCS home use: 11 active tDCS sessions: single session in the hospital and the remaining 10 in the subject's home, with duration of each active tDCS session of 20 min. Sham tDCS home use: 11 sessions of tDCS: single session in the hospital and the remaining 10 in the subject's home, with duration of each sham tDCS session of 20 min.

干预措施: Sham tDCS Home use (Device)

结局指标

主要结局

Cortical excitability on the transcranial magnetic stimulation (TMS)

时间窗: 2 days

Evaluation of the variation in cortical excitability parameters pre and post application of tDCS: Motor evoked potential (MEP); Motor threshold (MT); intracortical facilitation, intracortical inhibition, silent period (SP).

次要结局

  • Serum levels of Brain Derived Neurotrophic Factor (BDNF)(2 days)
  • Pressure pain threshold(2 days)
  • Heat pain threshold(2 days)
  • Conditional pain modulation (CPM)(2 days)
  • Number of participants with adverse events after use tDCS(10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolnei Caumo

Wolnei Caumo, MD, PhD

Hospital de Clinicas de Porto Alegre

研究点 (2)

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