阿尔茨海默氏症的TDC和认知培训的结合 (COMBINA-COG)
使用经颅直流刺激和阿尔茨海默氏症患者的认知训练进行了干预
该研究的一般目标是评估在轻度认知障碍和早期阶段阿尔茨海默氏病的患者中结合经颅直流刺激（TDC）和认知训练（CT）的短期和长期疗效。 将采用随机，双盲，安慰剂控制的设计。 将使用两组的受试者间设计：主动TDCS +并发CT和b。 假TDC +并发CT。 一个月后，将在预测试，后测和随访进行评估。 比较主动TDC与并发CT的假设是，尽管由于CT并发，两组都应改善，但预计主动TDCS组将显示出治疗后的改善。 此外，这些改进应在主动TDCS组的长期随访中维持，而在Sham TDCS组中，预计在随访措施中会返回基线。
TDCS刺激：将使用HDC刺激器（Newronika TM，意大利米兰）。 为了进行主动刺激，电流强度将在2 MA处恒定，刺激时间为每天20分钟，持续12天，初始和最终坡道为30秒。 对于安慰剂组，仅在初始和最终坡道期间应用电流以产生主动刺激的感觉。 将使用带有碳橡胶电极和海绵中的氯丁橡胶帽（5 x 5 cm）。 阳极将放置在左侧外侧前额叶皮层（DLPFC）上，并在右上北部区域（RSO）上放置阴极。
认知培训（CT）：CT将根据涉及执行功能和记忆的任务，包括每次50分钟的12个会话，包括分类，回答问题，短篇小说，解决问题，回忆起自传时刻，计划简单任务和时间表分析。
研究概览
地位
条件
详细说明
作为这项研究的初步步骤，应注意，将从Consorcio医院一般大学的神经病学服务中获得与患者的接触。 在开始研究并获得受试者参与之前，该服务将为潜在参与者提供有关与电刺激有关的研究的可能性，并指出他们将必须通过TDCS进行干预和十二天的认知刺激。 一旦从患者那里获得了可能参与的最初承诺，他们将被告知，他们将接到瓦伦西亚大学研究小组的电话，以安排面对面的预约，其中将为他们提供详细的信息。
在第一次约会期间，在指定的健康中心或专业中心举行，将对干预程序进行更详细的解释，并将从决定参加的那些受试者那里获得知情同意。 重要的是要强调，有关该程序的信息将强调与治疗的安全性和耐受性，对其的遵守性以及鉴于其家庭性质的易用性有关的方面。
从这一点开始，临床访谈将旨在评估一般健康状况并分析包容性和排除标准的实现；尽管将选择参与者在第二次任命期间进行首次评估，但还将进行神经心理学评估。 应当指出，早期痴呆症组参与者评估的总持续时间约为50分钟。
一旦获得基线评估，将设置与参与者的协调时间表，以确定治疗的开始及其连续性的分配持续时间；这方面至关重要，因为有必要从参与者那里获得连续性。 为了促进这一点，将提供灵活的开始日期，以避免在此过程中进行任何计划中断。 此外，鉴于其家庭性质，将获得家庭访问的必要信息，并将建立大概的干预时间以确保一致性。 为此，为此目的雇用的心理学家将访问参与者的家进行刺激。
该项目的主要关键点被认为是治疗依从性。 多次会议要求受试者反复前往治疗地点，为患者及其护理人员带来巨大且经常无法克服的负担，以及服务提供者的大量时间和成本，尤其是随着样本量的增加。 这种困难导致辍学率很高。 按照本项目的建议，在家中提供TDC和认知刺激治疗可以通过消除每个治疗课程前往医疗或研究设施的需求，从而减轻患者及其家人的负担，从而促进遵守和遵守治疗。 因此，在这项研究中实施概述的程序似乎不仅需要评估临床功效，而且还必须确保正确执行刺激并防止辍学。
此外，我们认为解决上述关键点的优势和关键偶然性策略之一是团队适应与此类患者及其护理人员的接触能力。 在这方面，至关重要的是实施已经应用于以前的项目并领先的全球医疗转型（称为患者以患者为中心的护理）的创新范式至关重要。 患者的参与和护理是研究和程序发展以及疾病管理的重要方面。 健康成果取决于患者的参与，并且显然需要与他们合作，在研究，开发，实施和进步健康程序中取得更好的结果。 创建以患者为中心的解决方案涉及从患者及其护理人员那里获得投入，就像该项目一样，并根据他们的需求和观点做出决定。 人性化科学有助于更好地接受，改善患者的关系和安全性，并有助于防止错误。
考虑到研究组，3个重复测量（前，后和随访），统计能力为95％，置信区间为95％，估计效应大小为η²= 0.16，我们需要n = 30个参与者，这意味着每组15名受试者。 此外，将获得两个分化样本以应用干预措施：轻度认知障碍患者和早期阿尔茨海默氏病的患者。
将使用具有2组的混合方差分析（主动与假的；在受试者之间）x 3评估（干预前，干预后和随访；在受试者内）进行分析数据。 TDC的功效应通过在这两个自变量之间找到显着相互作用来观察到。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Valencia
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Valencia、Valencia、西班牙、46010
- Universidad de Valencia
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准：
阿尔茨海默氏症前驱病：在MMSE上等于或高于或高于23分的评分，而得分等于全球恶化量表（GDS）的评分。
初始阿尔茨海默氏病：在MMSE上等于或高于或高于18分的评分，而得分等于全球恶化量表（GDS）的评分。
排除标准：
具有禁忌症的受试者（金属植入物，颅内，颅内高血压），严重的脑血管疾病或严重的精神病症状。
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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有源比较器：TDCS假和认知训练
对于主动比较组，将对刺激器进行编程，以便患者仅在坡道期间收到直流电流才能产生电流的感觉。
因此，它将在完成初始坡道后输入当前暂停，并将在最终坡道的最后几秒钟内激活。
认知培训计划将具有与实验组相同的特征。
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All participants will complete 10 home-based cognitive training sessions, each lasting 50 minutes.
The training will include structured tasks focused on executive function and memory, such as categorization, problem-solving, autobiographical recall, planning, and schedule analysis.
Instructions will be provided at the start of each session, and participants will work independently or with caregiver support.
Participants assigned to the sham tDCS group will also receive 10 home-based sessions of 20 minutes each.
However, to mimic the sensation of active stimulation without delivering therapeutic current, the stimulator will only apply current during the initial and final 30-second ramp periods.
The device will remain on for 20 minutes, but no current will be applied after the first ramp, simulating an active procedure without physiological effect.
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实验性的：tDCS active and cognitive training
tDCS: HDC stimulator will be used. For active stimulation, it will be programmed with a constant current intensity of 2mA and a stimulation time of 20 minutes daily for 10 days, with an initial and final ramp of 30 seconds. A neoprene cap based on the international 10-10 EEG system will be used for current passage to the skull. The electrodes will have two sponges (5 x 5 cm) soaked in saline solution for contact with the skull. The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode will be placed over the right supraorbital area (rSO). Cognitive training consists of a total of 10 sessions lasting 50 minutes each. These sessions will primarily focus on tasks involving executive functions and memory for a similar duration in each session. At the beginning of the sessions, instructions will be explained, followed by handing out activity sheets. The emphasis will not be on the outcome but on the cognitive activation process. |
The stimulation will use a neoprene cap with carbon rubber electrodes and sponges soaked in saline solution (5x5 cm).
The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC), and the cathode over the right supraorbital area (rSO).
Constant current intensity of 2mA and a stimulation time of 20 minutes per day for 10 days will be applied, with an initial and final ramp of 30 seconds.
All participants will complete 10 home-based cognitive training sessions, each lasting 50 minutes.
The training will include structured tasks focused on executive function and memory, such as categorization, problem-solving, autobiographical recall, planning, and schedule analysis.
Instructions will be provided at the start of each session, and participants will work independently or with caregiver support.
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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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Mini-Mental State Examination (MMSE) Scores at Baseline, Post-intervention, and Follow up
大体时间：Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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The Mini-Mental State Examination (MMSE) was used as an index of global cognitive functioning.
MMSE scores range from 0 to 30, with higher scores indicating lower cognitive impairment and therefore a better outcome.
This test was designed to estimate the existence and severity of cognitive impairment.
Participants with scores equal to or below 23 will be considered cognitively impaired.
Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment).
Post-intervention minus baseline difference scores were calculated, with a possible range from -30 to 30; positive scores reflect improvement.
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Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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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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Digits Wechsler Intelligence Scale for Adults-III (WAIS-III) Scores at Baseline, Post-intervention, and Follow up
大体时间：Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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Direct and inverse digits of the Wechsler Intelligence Scale for Adults-III (Wechsler, 2001) were used to assess attentional capacity by exposing participants to increasing amounts of information.
On the direct digits task, which assesses immediate recall, participants repeated the sequence of numbers in the same order in which they were presented by the examiner.
On the inverse digits task, which assesses working memory and mental flexibility, participants repeated the digits in reverse order.
Both tests are scored by assigning one point for each correct item, with scores ranging from 0 to 16; higher scores indicate better attentional performance and therefore a better outcome.
Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment).
Post-intervention minus baseline difference scores were calculated, with a possible range from -16 to 16; positive scores reflect improvement.
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Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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Complutense Verbal Learning Test (TAVEC) - Memory Scores at Baseline, Post-intervention, and Follow up
大体时间：Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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The Complutense Verbal Learning Test (TAVEC) presents a list of 16 words that, after being read by the evaluator, must be repeated by the participant.
The list is repeated five times (trials), and the participant is asked to recall the 16 words after each trial.
The test was administered to evaluate immediate memory (Trial 1) and learning ability (Trial 5).
Scores for each trial range from 0 to 16, with higher scores indicating better memory performance and therefore a better outcome.
Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment).
Post-intervention minus baseline difference scores were calculated, with a possible range from -16 to 16; positive scores reflect improvement.
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Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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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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Memory Alteration Test (M@T)- Cognitive Impairment Scores at Baseline, Post-intervention, and Follow up
大体时间：Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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The Memory Alteration Test (M@T) provides efficient and valid screening for amnestic mild cognitive impairment (A-MCI) and early-stage Alzheimer's disease (AD).
The test evaluates different cognitive abilities including encoding, orientation, semantic memory, and free recall.
Scores range from 0 to 50, with higher scores indicating better memory performance and therefore a better outcome.
The optimal cut-off point for distinguishing amnestic mild cognitive impairment from subjective memory complaints is 37 points, while the optimal cut-off point for Alzheimer's disease is 31 points.
Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment).
Post-intervention minus baseline difference scores were calculated, with a possible range from -50 to 50; positive scores reflect improvement.
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Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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Barcelona Test (BT) - Ability to Access and Recall Elements From the Lexical and Semantic Store Scores at Baseline, Post-intervention, and Follow up
大体时间：Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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Barcelona Test (BT) assesses lexical and semantic retrieval through two subtests: semantic fluency (animals, 1 minute) and phonological fluency (words beginning with "p", 3 minutes).
Scores correspond to the number of correctly produced words, with higher scores indicating better lexical-semantic performance and therefore a better outcome.
Good performance is defined as more than 16 animals and more than 19 words beginning with "p".
Scores are reported separately for each subtest, with no combined score.
This test assesses lexical and semantic memory, processing speed, cognitive flexibility, and working memory.
Assessments were conducted at baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment).
Post-intervention minus baseline difference scores were calculated, with positive scores reflecting improvement.
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Baseline, immediately post-intervention at 2 weeks, and follow-up at 6 weeks (4 weeks after post-intervention assessment)
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合作者和调查者
调查人员
- 首席研究员：Juan C Melendez, PhD、University of Valencia
出版物和有用的链接
一般刊物
- Melendez JC, Satorres E, Pitarque A, Delhom I, Real E, Escudero J. Effectiveness of tDCS at Improving Recognition and Reducing False Memories in Older Adults. Int J Environ Res Public Health. 2021 Feb 1;18(3):1317. doi: 10.3390/ijerph18031317.
- Satorres E, Escudero Torrella J, Real E, Pitarque A, Delhom I, Melendez JC. Home-based transcranial direct current stimulation in mild neurocognitive disorder due to possible Alzheimer's disease. A randomised, single-blind, controlled-placebo study. Front Psychol. 2023 Jan 3;13:1071737. doi: 10.3389/fpsyg.2022.1071737. eCollection 2022.
- Satorres E, Melendez JC, Pitarque A, Real E, Abella M, Escudero J. Enhancing Immediate Memory, Potential Learning, and Working Memory with Transcranial Direct Current Stimulation in Healthy Older Adults. Int J Environ Res Public Health. 2022 Oct 5;19(19):12716. doi: 10.3390/ijerph191912716.
- Hill AT, Fitzgerald PB, Hoy KE. Effects of Anodal Transcranial Direct Current Stimulation on Working Memory: A Systematic Review and Meta-Analysis of Findings From Healthy and Neuropsychiatric Populations. Brain Stimul. 2016 Mar-Apr;9(2):197-208. doi: 10.1016/j.brs.2015.10.006. Epub 2015 Oct 23.
- Bahar-Fuchs A, Martyr A, Goh AM, Sabates J, Clare L. Cognitive training for people with mild to moderate dementia. Cochrane Database Syst Rev. 2019 Mar 25;3(3):CD013069. doi: 10.1002/14651858.CD013069.pub2.
- Gates NJ, Vernooij RW, Di Nisio M, Karim S, March E, Martinez G, Rutjes AW. Computerised cognitive training for preventing dementia in people with mild cognitive impairment. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD012279. doi: 10.1002/14651858.CD012279.pub2.
- Melendez JC, Escudero J, Satorres E, Pitarque A, Marti-Hoyos I, Gonzalez-Moreno J. Combined home-delivered transcranial direct current stimulation and cognitive training in older adults with mild cognitive impairment due to Alzheimer's disease: a randomized, single-blind, sham-controlled trial. BMC Geriatr. 2026 Apr 11;26(1):715. doi: 10.1186/s12877-026-07481-z.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2601758
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IPD 计划说明
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