Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Neuroimaging Assessment
研究概览
简要总结
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.
详细描述
Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA) score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between groups.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First-ever stroke patients
- •Subacute stage (less than 4 weeks)
- •Total Fugl-Meyer Assessment (FMA) score under 84
排除标准
- •Major active neurological disease or psychiatric disease
- •A history of seizure
- •Metallic implants in their brain
研究组 & 干预措施
Dual-mode stimulation
rTMS on ipsilesional M1 + tDCS on contralesional M1
10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
干预措施: rTMS on ipsilesional M1 (Device)
Dual-mode stimulation
rTMS on ipsilesional M1 + tDCS on contralesional M1
10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
干预措施: tDCS on contralesional M1 (Device)
Single stimulation
rTMS on ipsilesional M1
10 Hz of rTMS over the ipsilesional M1 was applied for 20 minutes.
Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
干预措施: rTMS on ipsilesional M1 (Device)
结局指标
主要结局
Neuroimaging Assessment
时间窗: Change from baseline resting-state brain network at 8 weeks after intervention
Resting-state fMRI
次要结局
未报告次要终点