Effects of Transcranial Direct Current Stimulation Associated With Cognitive Training in Alzheimer's Disease
2020年1月6日 更新者：Suellen Marinho Andrade、Federal University of Paraíba
Effects of Transcranial Direct Current Stimulation Associated With Cognitive Training in Alzheimer's Disease: Clinical Trials, Triple-blind and Randomized
Alzheimer's disease (AD) is characterized by a progressive decline in cognitive functions, interfering with autonomy and independence.
According to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5), mnemonic dysfunction in AD must be related to aphasia, apraxia, agnosia, or changes in executive function.
The clinical picture of the disease can be described as mild, moderate and severe.
In the mild phase, the patient is disoriented and with difficulties in thinking, in later stages memory lapses become more intense and frequent.
The symptoms of apraxia, aphasia and agnosia appear, causing a noticeable impact on the performance of simple daily activities, and neuropsychiatric and behavioral symptoms are expressed.
Existing pharmacological treatments for AD treatment are able to minimize the symptoms of the disease, but are not able to promote cure.
Therefore, studies have sought to better understand non-pharmacological strategies, aiming at optimizing the benefits of using the drug.
Studies have suggested that tDCS promotes significant effects on cognitive processes assessed through cognitive tasks, not only in healthy individuals but also in clinical populations.
Cognitive training (TCog) has similarly shown excellent results in the treatment of cognitive deficits due to AD.
Thus, the present study aims to investigate when (before, during or after) the tDCS should be applied to potentiate the effects of TCog in people with AD by comparing four protocols of application of neurostimulation associated with TCog.
研究概览
详细说明
It consists of a randomized, triple-blind, placebo-controlled clinical trial.
The AETCC must be associated with the Tcog.
Patients diagnosed in mild to moderate AD will be randomized into four groups: G1, aETCC before TCog; G2, aETCC during TCog; G3 aETCC after TCog and G4: simulated aETCC during TCog.
Groups G1, G2 and G3 will receive the active current, while G4 will receive the simulated current.
In each condition, an initial baseline assessment (T0) will be performed after 12 sessions (T1) and three weeks after the end of interventions (T2).
The outcomes evaluated will be: cognition, executive function, functionality, neuropsychiatric symptoms and occupational performance.
For all analyzes, SPSS (Statistical Package for Social Sciences - SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and considered as significant, an alpha value of 5% (p <0.05 ).
研究类型
介入性
注册 (预期的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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PB
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João Pessoa、PB、巴西
- 招聘中
- Suellen Andrade
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接触：
- Gabriella Conserva
- 电话号码：+55 83 98747-1386
- 邮箱：gabriellac.to@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Patients will be included in this study following the following requirements: (a) age between 55 and 85 years; (b) probable diagnosis AD; (c) scores higher than 18 on the Mini Mental State Examination (MMSE); (e) did not receive regular cognitive intervention within 3 months prior to the start of this clinical trial.
Exclusion Criteria:
- Patients will be excluded from this study while not meeting the following criteria: (a) individuals with severe metabolic and / or cardiac disorders, alcoholism, focal neurological disorders and associated psychiatric disorders; (b) use of hypnotics and benzodiazepines two weeks prior to study initiation; or (c) use of medication with cholinergic inhibitors and memantine for more than two months prior to this clinical trial; (d) or with any condition that could impair the neuropsychological assessment process or receive a cognitive intervention protocol from the study will be excluded from the study. In addition, participants with transient or definitive pacemakers, cochlear implants, or intracranial aneurysm clips will be excluded; (e) individuals with a history of seizures; (f) the presence of tumors, epilepsy or substance abuse.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：aETCC before TCog
Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog).
Duration: 20 minutes; Intensity: 2mA.
|
2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions.
In each session activities aimed at stimulating cognition will be applied over the 20 minutes.
|
|
实验性的：aETCC during TCog
Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog).
Duration: 20 minutes; Intensity: 2mA.
|
2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions.
In each session activities aimed at stimulating cognition will be applied over the 20 minutes.
|
|
实验性的：aETCC after TCog
Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog).
Duration: 20 minutes; Intensity: 2mA.
|
2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions.
In each session activities aimed at stimulating cognition will be applied over the 20 minutes.
|
|
假比较器：Simulated aETCC during TCog
Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog).
Duration: 20 minutes; Intensity: 2mA.
|
2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions.
In each session activities aimed at stimulating cognition will be applied over the 20 minutes.
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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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Change in global cognitive function by the Alzheimer's Disease Assessment Scale (ADAS-Cog)
大体时间：baseline, after 4 weeks and after 12 weeks
|
Cognitive Scale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), consisting of 11 items that assesses performance related to memory, language, praxis and comprehension skills, with a maximum score of 70 points.
Thus, the higher the score, the more compromised the individual is.
Application takes about 30 minutes (Mohs & Cohen, 1988).
In addition, the Montreal Cognitive Assessment (MoCA), a cognitive screening tool created by Nasreddine et al. (2005).
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baseline, after 4 weeks and after 12 weeks
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Change in global cognitive function by the Montreal Cognitive Assessment (MoCA)
大体时间：baseline, after 4 weeks and after 12 weeks
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MoCA is composed of eight cognitive domains, which are scored within a range of 0 to 30 points (higher scores indicate better function): short-term memory; visuospatial skills; executive function; verbal fluency; attention, concentration and working memory; language; sentence repetition; and spatiotemporal orientation.
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baseline, after 4 weeks and after 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Executive Function by the Trail Making Test (TMT)
大体时间：baseline, after 4 weeks and after 12 weeks
|
The Trail Making Test (TMT) will be administered (Reitan, 1958).
From a clinical point of view, TMT is widely used as an indicator of brain dysfunction.
TMT is divided into two parts, TMT-A and TMT-B.
In the first, circles numbered 1 to 25 following the randomly arranged numerical sequence should be connected, time taken and considered, ie the task should be performed as soon as possible.
In the TMT-B task, the connection must alternate between numbers and letters.
The TMT (AB) scores consist of the time taken to complete each part, other derived scores are used, such as the difference score (TMT-B - TMT-A) and the ratio score (TMT-A) / TMT- B) (Llinàs-Reglà et al, 2015).
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baseline, after 4 weeks and after 12 weeks
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Change in Executive Function by the Tower of London
大体时间：baseline, after 4 weeks and after 12 weeks
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The Tower of London (Shallice, 1982) has been used in studies to evaluate executive function in elderly with AD (Satler, Guimarães, Tomaz, 2016).
Tower of London is made up of three vertical pins of different heights and three colored spheres, with a hole in the center to fit the pins.
The goal is to move them to reproduce, in a given number of moves, the position of a presented target figure.
There are 15 problems with increasing difficulty and reduced possibilities for moving parts.
Three attempts to resolve the issue are allowed.
Will be evaluated: total and average execution time, and total score, obtained by the sum of the points of each step, ranging from 0 to 3.
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baseline, after 4 weeks and after 12 weeks
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Change in Functionality by the Disability Assessment for Dementia (DAD)
大体时间：baseline, after 4 weeks and after 12 weeks
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Disability Assessment for Dementia (DAD) (Gauthier, et al., 1997; Gélinas et al., 1999).
The DAD comprises 17 items that assess ADLs and 23 items that assess instrumental ADL (iADL) and leisure activities.
In the category related to ADLs are evaluated hygiene, dressing, undressing, continence and food.
IADL assessment and leisure activities consist of tasks related to meal preparation, phoning, sightseeing, finances and correspondence, medication and leisure, and housework (Feldman et al. (2001; Suh et al., 2004).
maximum score is 100, lower scores indicate higher level of impairment (Bahia et al., 2010).
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baseline, after 4 weeks and after 12 weeks
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Change in Neuropsychiatric symptoms by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
大体时间：baseline, after 4 weeks and after 12 weeks
|
This outcome will be assessed with the Neuropsychiatric Inventory Questionnaire (NPI-Q; Kaufer et al., 2000).
This instrument consists of a self-administered caregiver scale and provides information on 12 characteristic behavioral and psychological symptoms in patients with dementia.
The severity level will be identified (1 = mild, 2 = moderate, 3 = severe).
The overall severity score ranges from 0 to 36, with zero indicating no neuropsychiatric symptoms.
The reliability and validity of this modified NPI score have been previously established (NPI-Q; Kaufer et al., 2000).
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baseline, after 4 weeks and after 12 weeks
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Change in Occupational performance by theCanadian Occupational Performance Measure (COPM)
大体时间：baseline, after 4 weeks and after 12 weeks
|
The Canadian Occupational Performance Measure (COPM) (Law et al., 2009) will be used to assess occupational performance, ie engagement in daily activities.
The COPM is can be applied with the patient or caregiver, following four steps, firstly it seeks to identify which areas of occupational performance are impaired, ie, which occupations are compromised, and then assign a value from 1 to 10 to measure the degree of importance that the activities listed have for the interviewee or caregiver.
Next, five of these activities are organized by priority, and each of them should be assigned a value between 1 and 10 to describe the interviewee's performance and satisfaction respectively.
In the end, the averages of performance and satisfaction are calculated.
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baseline, after 4 weeks and after 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Suellen Andrade、Universidade Federal da Paraíba
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年11月25日
初级完成 (预期的)
2020年10月1日
研究完成 (预期的)
2020年12月1日
研究注册日期
首次提交
2019年11月26日
首先提交符合 QC 标准的
2020年1月6日
首次发布 (实际的)
2020年1月7日
研究记录更新
最后更新发布 (实际的)
2020年1月7日
上次提交的符合 QC 标准的更新
2020年1月6日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.