Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Upper Limb function
研究概览
简要总结
The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with 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 (Participant, Care Provider)
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
- 是
入选标准
- •stroke onset >3 months prior to study enrollment
- •subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
- •subject can move, stand up and stand firmly with constrained healthy hand
- •subject can perform training 6 hours daily in 2 weeks
- •subject is able to understand instructions and be able to cooperate
排除标准
- •pregnancy
- •contraindications to MRI of brain
- •epilepsy, major psychiatric disease
- •excessive pain that prevents training
- •history of other diseases resulting decreased mobility of affected upper limb
研究组 & 干预措施
CIMT + active anodal tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min.
干预措施: active anodal transcranial Direct Current Stimulation (tDCS) (Device)
CIMT + active anodal tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min.
干预措施: Constraint Induced Movement Therapy (CIMT) (Behavioral)
CIMT + sham tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation
干预措施: sham transcranial Direct Current Stimulation (Device)
CIMT + sham tDCS
Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation
干预措施: Constraint Induced Movement Therapy (CIMT) (Behavioral)
Healthy control subjects
20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain.
结局指标
主要结局
Change in Upper Limb function
时间窗: Baseline and posttest (an average of 2 weeks from baseline)
The motor function assessment will be done with: Wolf Motor Function Test
次要结局
- GABA (gamma-aminobutyric acid) activity(Baseline)
研究者
Krystian Figlewski
MD
University of Aarhus