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临床试验/NCT04101695
NCT04101695已完成不适用

Hemodynamic Response of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Cerebellar Hemisphere in Healthy Subjects: A Pilot Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Changes of concentration of deoxyhemoglobin

研究概览

简要总结

Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitation of activities of daily livings. Noninvasive neuromodulation is one of the therapies for motor recovery, which includes transcranial magnetic stimulation and transcranial direct current stimulation(tDCS). Anodal tDCS increases excitability and cathodal tDCS decreases excitability of neurons.

In systematic reviews, tDCS applied over primary motor cortex showed positive results on motor learning and improvements of hand fine motors. Recently, there has been trials of tDCS over cerebellum, considering the connectivity of primary motor cortex and cerebellum in motor controls. However, the results of these trials are yet contradictory, and the study using the functional near infrared spectroscopy to prove the effects of tDCS over distant area is lacking.

Therefore, in this study, we used functional near infrared spectroscopy (fNIRS) to observe the hemodynamic change of primary motor cortex when applying tDCS over cerebellum ascertain their connectivity.

In this crossover design, participants are randomly allocated to "sham tDCS-washout period-anodal tDCS group" or "anodal tDCS- washout period- sham tDCS group". The recording of fNIRS starts 3 minutes before the tDCS stimulation and continues throughout 20 minutes of stimulation, until 30 minutes after the stimulation cessation. After 7 days of washout period, second recording is done as the same protocol. Outcome measures are the changes of concentration of deoxyhemoglobin [deoxy-Hb] and oxyhemoglobin [oxy-Hb].

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 19 years or older
  • No known brain disorders

排除标准

  • Uncontrolled or unstalbe medical condition
  • Scalp problem which interferese with tDCS
  • metals in the head (example: clip, coil), cochlear implants

结局指标

主要结局

Changes of concentration of deoxyhemoglobin

时间窗: comparison between sham and anodal tDCS (at least 7 days apart)

detected by fNIRS and implies cortical metabolic changes

Changes of concentration of oxyhemoglobin

时间窗: comparison between sham and anodal tDCS (at least 7 days apart)

detected by fNIRS and implies cortical metabolic changes

次要结局

未报告次要终点

研究者

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

Won-Seok Kim

Professor

Seoul National University Hospital

研究点 (2)

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