A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- MMSE
研究概览
简要总结
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 year-old
- •diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- •cognitive function, perceptual function decline after stroke
- •first onset and duration of 3-12 months
- •right-handed
- •sign informed consent voluntarily and comply with the study plan
排除标准
- •NIHSS ≥21 points
- •MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- •taking drugs that affect central nervous activity, such as nerve antagonists
- •specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- •patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
- •patients with a previous history of epilepsy, mental illness or skull injury
- •patients with dementia or obvious cognitive dysfunction before stroke
- •patients with aphasia or dysarthria and cannot complete the scale evaluation
- •pregnancy
结局指标
主要结局
MMSE
时间窗: Change from Baseline MMSE at 2 weeks and 3 months after intervention
Mini-mental State Examination
WAIS-DST
时间窗: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
WAIS Digit Symbol Test
MoCA
时间窗: Change from Baseline MoCA at 2 weeks and 3 months after intervention
Montreal Cognitive Assessment
AVLT
时间窗: Change from Baseline AVLT at 2 weeks and 3 months after intervention
The Auditory-Verbal Learning Test
次要结局
- GNAT(Change from Baseline GNAT at 2 weeks and 3 months after intervention)
- DEX(Change from Baseline DEX at 2 weeks and 3 months after intervention)