Bihemispheric Modulation of the Motor Cortex by Repetitive Transcranial Direct Current Stimulation After Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Fugl-Meyer test
研究概览
简要总结
Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. In this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.
详细描述
Investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be randomly allocated to receive daily bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or daily sham tDCS (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. Changes in upper extremity motor function score (Fugl-Meyer test and Action Research Arm test), corticospinal excitability from the transcranial magnetic stimulation(TMS), and sensorimotor oscillations from the magnetoencephalography (MEG) will be assessed before and after intervention, as well as 3 months after stroke. All stroke patients will receive tDCS and standard medical, rehabilitation treatments in rehabilitation ward.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80 years old
- •Patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness
- •Brain MRI confirmed subcortical stroke in the middle cerebral artery territory
- •Post-stroke 2-6 weeks with stable clinical condition
排除标准
- •Stroke with cortical lesions
- •Containing metal implants (such as implanted electrodes, pacemakers)
- •Sensitive or fear of electromagnetic waves
- •Pregnant women
- •History of alcohol or drug abuse
- •History of seizures or epilepsy
- •Claustrophobia
- •Other significant disease or neuropsychiatric disorders
研究组 & 干预措施
True stimulation
True repetitive bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, daily 20 minutes for 20 sessions
干预措施: Bihemispheric transcranial direct current stimulation (Device)
Sham stimulation
Repetitive bihemispheric transcranial direct current stimulation, as the experimental stimulation condition but only for 120 seconds
干预措施: Bihemispheric transcranial direct current stimulation (Device)
结局指标
主要结局
Fugl-Meyer test
时间窗: baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke
stroke motor function scale
次要结局
- Motor evoked potential(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Active motor threshold(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Ipsilateral silent period(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Action Research Arm test(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Resting state functional connectivity(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Short interval intracortical inhibition(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Modified Rankin Scale(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Motor task ERD peak amplitude(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)
- Motor task ERS peak amplitude(baseline, change from baseline after 2 weeks' intervention, change from baseline at 3 months after stroke)