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
- 29
- 试验地点
- 1
- 主要终点
- Accuracy of 2-back verbal working memory task
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 post-stroke cognitive impairment patients' cognitive 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 facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in post-stroke cognitive impairment patients.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever stroke patients
- •Subacute stage (less than 4 weeks)
- •Who can perform the 2-back verbal and non-verbal working memory task
排除标准
- •K-MMSE score under 9
- •Major active neurological disease or psychiatric disease
- •A history of seizure
- •Metallic implants in their brain
研究组 & 干预措施
Single sham stimulation
10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the right DLPFC.
Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.
干预措施: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC (Device)
Anodal Dual-mode stimulation
10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of anodal tDCS on the right DLPFC.
Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.
干预措施: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC (Device)
Cathodal Dual-mode stimulation
10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of cathodal tDCS on the right DLPFC.
Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.
干预措施: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC (Device)
结局指标
主要结局
Accuracy of 2-back verbal working memory task
时间窗: Change from Pre-intervention at 2 months
Accuracy (percentile) of 2-back verbal working memory task
次要结局
未报告次要终点