Hemodynamic Response of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Cerebellar Hemisphere in Healthy Subjects: A Pilot Trial
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
- 是
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
Won-Seok Kim
Professor
Seoul National University Hospital
