Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Behavioral Inattention Test
研究概览
简要总结
The primary objective of this study is to confirm and compare the effect of methods of transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients
详细描述
Total 105 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into two types; Pre-tDCS group and Simultaneous tDCS group. Two groups are again divided into three groups; Dual stimulation group, Unilateral stimulation group and Sham control group, respectively.
In Pre-tDCS group, total a sessions of the tDCS stimulation was done for each three subgroups and visual inattention training was followed after that. In Simultaneous tDCS group, tDCS and visual inattention training was done simultaneously. For each subgroups, tDCS was attached at following locations; unilateral cathodal tDCS on unaffected PPC(postparietal cortex), P3 , dual cathodal tDCS on P3 and anodal tDCS on affected PPC, P4.
The patients were initially evaluated at baseline, immediately, 60min, 120min, 24 hrs after the training session.
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 ages older than 18years old
- •Subjects who have 19 of K-MMSE score
- •Subjects who has unilateral neglect with BIT-C less than 129
- •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
- •Subjects whose dominant side are confirm by Edinburgh Handedness Inventory
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
Pre-tDCS group
In Pre-tDCS group, total sessions of the transcranical direct current stimulator stimulation(tDCS) was done for each three subgroups and visual inattention training was followed after that.
Patient had 2 times of tDCS for 13 minutes with 20minutes of resting interval. After that, additional 2 times of Visual inattention training was done with same protocol.
干预措施: Transcranical direct current stimulator (Device)
Pre-tDCS group
In Pre-tDCS group, total sessions of the transcranical direct current stimulator stimulation(tDCS) was done for each three subgroups and visual inattention training was followed after that.
Patient had 2 times of tDCS for 13 minutes with 20minutes of resting interval. After that, additional 2 times of Visual inattention training was done with same protocol.
干预措施: Visual inattention training (Behavioral)
Sham control group
without transcranical direct current stimulator(tDCS) or without visual training
Simultaneous tDCS group
In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.
干预措施: Transcranical direct current stimulator (Device)
Simultaneous tDCS group
In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.
干预措施: Visual inattention training (Behavioral)
结局指标
主要结局
Behavioral Inattention Test
时间窗: up to 2 min
Line bisection test
次要结局
- Behavioral Inattention Test(60 min, 120 min, 24 hrs after intervention)
- ADL assssement(60 min, 120 min, 24 hrs after intervention)
研究者
Yong-il Shin
Associate Professor
Pusan National University