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临床试验/NCT04245059
NCT04245059Unknown不适用

Safety Study Based on Transcranial Electrical Stimulation in Chile: a Case Series Study

Corporación de Rehabilitación Club de Leones Cruz del Sur2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3
试验地点
2
主要终点
Change of Side effect checklist for transcranial direct current stimulation

研究概览

简要总结

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. It has been used to improve cognitive functions such as memory, language, and attention. Research has also shown that tDCS on motor cortex can improve motor performance.

TDCS secondary effects have been measured in several studies. The most frequent secondary effects described in literature are a mild tingling sensation, moderate fatigue, itching sensation, slight burning and mild pain sensation under the electrodes during the stimulation.

The present study is focused in evaluate the safety of a transcranial direct current stimulation (TDCS) service by measuring secondary effects incidence in a group of healthy subjects. In addition, manual dexterity and upper limb strength will be measure to identify improvement in motor performance after intervention.

详细描述

Transcranial electrical stimulation (tES) is a neurophysiological technique capable of modulating the excitability of the neuronal tissue of the central and peripheral nervous system through the application, for a finite time length, of an electrical field. This electric field is generated by the application of weak electrical currents through the scalp and into the brain. It has been demonstrated in recent years that the technique is safe and beneficial if used within the known bounds of intensity, density and duration.

The tES technique is classified into three types according to the waveform of the stimulation current that is applied: Transcranial direct current stimulation (tDCS),Transcranial Alternating Current Stimulation (tACS) and Transcranial random noise stimulation (tRNS). Additionally, the Sham mode can be used for controlled experiments.

TDCS is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In general, the current is injected into the brain (anodal stimulation) over a cortical region leading to excitatory effects; and collected from the brain (cathodal stimulation) leading to inhibitory effects. tDCS produces short term effects on neuronal excitability, and long lasting plastic after/effects involving synaptic modification.

Research has shown that applying anodal tDCS to the non-dominant motor cortex can improve motor performance for the non-dominant hand, presumably by means of changes in synaptic plasticity between neurons. Other studies suggest improvement on cognitive functions such as memory, language, and attention after a tDCS program.

TDCS secondary effects have been measured in several studies. The most frequent secondary effects described in literature are a mild tingling sensation, moderate fatigue, itching sensation, slight burning and mild pain sensation under the electrodes during the stimulation. A visual sensation, associated with switching on and off the stimulation, have been also described. Less frequent are the difficulties in concentrating, headache, felt nervous or overexcited and nausea after the stimulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects
  • Both gender
  • Informed consent accepted

排除标准

  • Neurological diseases
  • Mental diseases
  • Injuries in the scalp skin
  • Inflammatory tegumentary diseases
  • Migraines
  • Medication or substances affecting central nervous system
  • Presence of chronic diseases
  • Presence of degenerative diseases
  • Pregnancy

结局指标

主要结局

Change of Side effect checklist for transcranial direct current stimulation

时间窗: Baseline, 4 weeks

A checklist that records side effect after TDCS sessions including fatigue, headache or dizziness, nausea, and a itching sensation in the stimulation area.

Change of block and box test score

时间窗: Baseline, 4 weeks

Change of the Box and Block test score, it's a measure of the number of blocks the subject can move in 1 minute, between the beginning (T0) and immediately after the end of treatment (T1). Range of score 0-120. A positive change represents improved performance on Box and Blocks test.

次要结局

  • Change of nine hole peg test score(Baseline, 4 weeks)
  • Change of pinch strength measurement(Baseline, 4 weeks)
  • Change of grip strength measurement(Baseline, 4 weeks)

研究者

发起方
Corporación de Rehabilitación Club de Leones Cruz del Sur
申办方类型
Other
责任方
Sponsor

研究点 (2)

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