Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
研究概览
简要总结
The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.
详细描述
120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis
- •Subjects who have cortical or subcortical brain lesion
- •Subjects who was diagnosed as stroke within 6 months
- •Subjects ages from 18years to 80years old
- •Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury
- •Subjects who is possible to receive swallowing function intervention 5 days a week
- •Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver
- •Subjects who had no effect from brain stimulation or electrical stimulation therapy
排除标准
- •Subjects who have pre-existing and active major neurological disease
- •Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- •Subjects who have brain lesion except cortex or subcortex area
- •Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure
- •Subjects who is estimated as not appropriate for the study by the investigators
研究组 & 干预措施
Eldith DC-STIMULATOR group
Intervention:
20-minutes of transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (30 applications for each 3 groups: total 90 applications)
干预措施: Eldith DC-STIMULATOR (Device)
sham-Eldith DC-STIMULATOR group
Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)
干预措施: Sham Eldith DC-STIMULATOR (Device)
结局指标
主要结局
Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
时间窗: up to 60 sec
次要结局
- Korean Version of Modified Barthel Index(K-MBI)(up to 2 weeks after tDCS)
- Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing(2 weeks after tDCS)
- American Speech-LanguageHearing Association(ASHA)-Norms(up to 2 weeks after tDCS)
研究者
Yong-il Shin
Associate Professor
Pusan National University