The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment
The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.
Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.
Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.
Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、香港、Hung Hom
- 招聘中
- The Hong Kong Polytechnic University
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接触:
- Pablo Cruz Gonzalez
- 电话号码:+85262382024
- 邮箱:pablo.cruzgonzalez@connect.polyu.hk
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接触:
- Kenneth Fong
- 电话号码:+85227666716
- 邮箱:rsnkfong@polyu.edu.hk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
The inclusion criteria will follow the modified Petersen's criteria:
- Aged between 60 and 85 years old;
- Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
- Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
- Self-reported cognitive decline by the participants themselves and
Being independent in daily living activities.
Additional criteria in this study include:
- Having completed three or more years of primary education;
- Ability to participate in a therapy session lasting at least 30 minutes;
- Community ambulant with or without aids; and
- Ability to perform a proper range of motion with hands in order to use a tablet PC.
Exclusion Criteria:
- 1) Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:tDCS+CT
application of tDCS in combination with CT
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经颅直流电刺激
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假比较器:Sham tDCS
application of sham tDCS in combination with CT
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经颅直流电刺激
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有源比较器:CT
application of CT
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经颅直流电刺激
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Montreal Cognitive Assessment (MoCA)
大体时间:10 minutes
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It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
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10 minutes
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Digit Span Test
大体时间:10 minutes
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The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order.
Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.
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10 minutes
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Trial Making Test (TMT)
大体时间:5 minutes
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TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected.
Time performance is measured as the main outcome
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5 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
大体时间:40 minutes
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It includes 14 subtests assessing aspects of visual, verbal, recall, recognition, immediate and delayed everyday memory.
Additionally prospective memory skills and the ability to learn new information are measured as well
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40 minutes
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Cognitive training activities ( Neuronup cognitive training)
大体时间:30 minutes each session ( 9 sessions in total)
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Performance of the cognitive training activities conducted every session
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30 minutes each session ( 9 sessions in total)
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EEG
大体时间:15 minutes
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time and spatial responses of tDCS on the brain cortex before and after tDCS application
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15 minutes
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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tDCS的临床试验
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Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta de Andalucía, Spain邀请报名
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Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)未知
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完全的
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University of California, Los AngelesNational Institute of Mental Health (NIMH)完全的
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Charite University, Berlin, GermanyPhysikalisch-Technische Bundesanstalt Institut Berlin (PTB)完全的