Multisite Transcranial Direct Current Stimulation Targeting Motor Network by Mapping Electric Fields With Task-based fMRI to Promote Hand Function Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment Upper Extremity
研究概览
简要总结
A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond traditional stimulation which targeting only one region. It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS. To consider the various lesion site of different stroke survivors. The electrode placements based on personalized lesion profiles and anatomical features can be determined using finite element modeling, with lesion profiles generated from fMRI and advanced algorithms calculating the current density to maximize the modulation effect. Combining motor network interaction and the new multisite electrode montage may further provide a potential to facilitate stroke recovery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •first-ever stroke, the duration after stroke exceeds 12 months;
- •mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53;
- •detectable voluntary muscle sEMG signal from flexor digitorum (FD) and extensor digitorum (ED);
- •scored below 3 in the Modified Ashworh Score (MAS) of FD and ED;
- •sufficient cognitive function to follow the assessment and training instructions, determined by Mini Mental State Examination score of more than 21.
排除标准
- •history of epilepsy, or any other contradictions of brain stimulation;
- •severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.
研究组 & 干预措施
multisite HD-tDCS with EMG-driven robot hand group
The stimulation electrodes are fixed on the ipsilesional sensorimotor cortex according to the brain activation map detected by task based fMRI.
干预措施: multisite HD-tDCS EMG-driven robot hand (Device)
Sham HD-tDCS EMG-driven robot hand group
The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered.
干预措施: Sham HD-tDCS EMG-driven robot hand (Device)
结局指标
主要结局
Fugl-Meyer Assessment Upper Extremity
时间窗: 6-month after intervention
It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale
次要结局
- Action Research Arm Test(6-month after intervention)
- Magnetic Resonance Imaging (MRI)(6-month after intervention)
- Electroencephalography (EEG)(6-month after intervention)
- Electromyography (EMG)(6-month after intervention)
研究者
Raymond KY Tong
Professor and Chairman
Chinese University of Hong Kong