Bihemispheric Modulation of the Motor Cortex by Single-session Transcranial Direct Current Stimulation During Training in Subacute Stroke Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- transcranial magnetic stimulation (TMS)
研究概览
简要总结
Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance after-effects of rehabilitation through membrane polarization modulation. In this double-blind, crossover randomized controlled trial, we aim to investigate whether single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy modulates ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.
详细描述
We will consecutively enroll subacute (2-4 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 assessed for baseline upper extremity motor function (Fugl-Meyer test and Action Research Arm test), structural and functional magnetic resonance imaging (fMRI). A single session of bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or sham tDCS (same but stimulation for only 2 min) with simultaneous physical/occupational therapy will be tested in each subject with a randomized sequence on different days (at least two days apart from each other). All stroke patients will receive standard medical and rehabilitation treatments during the study period. Changes in corticospinal excitability and transcallosal inhibition from the TMS study, as well as sensorimotor oscillations, MEG source projection, and functional connectivity from the task-related MEG will be assessed immediately before and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •subacute (2-4 weeks after stroke onset) patients
- •first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory
- •mild to moderate hand weakness (MRC 2-4/5)
排除标准
- •cerebral cortex 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 EEG recording
- •other significant disease or neuropsychiatric disorders
- •claustrophobia
- •fixed dentures over two or more (enough to interfere with MEG signals)
研究组 & 干预措施
transcranial direct current stimulation
bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, for 20 minutes
干预措施: Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK) (Device)
sham stimulation
same as the experimental stimulation condition but only for 2 minutes
结局指标
主要结局
transcranial magnetic stimulation (TMS)
时间窗: up to 20 minutes
次要结局
未报告次要终点
