ChiCTR-TRC-14005036尚未招募4 期
工作記憶訓練與腦部直流電剌激對輕度阿氏認知障礙症之治療成效研究
Research Grant Council of Hong Kong (General Research Fund)1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2014年11月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- 1. Working memory test – the n-back task performance at baseline, 4th, 8th and 12th weeks would be recorded as a direct measure of improvement in task performance.
研究概览
简要总结
工作記憶訓練與腦部直流電剌激對輕度阿氏認知障礙症之治療成效
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 60 至 90（—）
- 性别
- All
入选标准
- •Subjects 60 to 90 years old;
- •DSM-5 diagnosis of Mild Neurocognitive Disorder due to Alzhemers disease.
排除标准
- •Previous diagnosis of other major neurocognitive disorders;
- •Past history of bipolar affective disorder or psychosis;
- •Physically frail affecting attendance to training sessions;
- •Already attending regular cognitive training;
- •Taking a psychotropic or other medication known to affect cognition (e.g. benzodiazepines, anti-dementia medication, etc.);
- •History of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury,
- •Significant communicative impairments.
研究组 & 干预措施
Two groups
transcranial direct current stimulation and computer based working memory training four weeks versus 4 week intervention of either tDCS-working memory (DCS-WM), tDCS-control cognitive training(DCS-CC), and sham tDCS-working memory (WM-CD) groups
结局指标
主要结局
1. Working memory test – the n-back task performance at baseline, 4th, 8th and 12th weeks would be recorded as a direct measure of improvement in task performance.
2. Global Cognitive function would be measured by the Chinese version of the Alzheimer’s disease Assessment Scale – Cognitive Subscale (ADAS-Cog).
次要结局
- 1. Memory and Language tests – Logical memory, 10 minutes list learning delay recall, category verbal fluency and trail making tests would also be evaluated to examine the effects of both tDCS and working memory training on other cognitive abilities
- 2. The Chinese Neuropsychiatric Inventory (NPI) would used to assess changes in neuropsychiatric symptoms across different 12 domains. In the current study, NPI would evaluate potential mood and behavioral change, especially mood and euphoria that may theoretically be affected by tDCS administration.
- 3. A checklist of potential adverse effects associated with computer based cognitive training and t-DCS administration would be generated from available literature reports. The checklist would be used to monitor tolerability and adverse events throughout intervention.
研究者
研究点 (1)
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