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经颅直流电刺激(tDCS)能否增强阿尔茨海默病所致轻度神经认知障碍老年人的工作记忆训练效果:一项随机对照试验的研究方案

Would transcranial direct current stimulation (tDCS) enhance the effects of working memory training in older adults with mild neurocognitive disorder due to Alzheimer's disease: study protocol for a randomized controlled trial.

作者信息

Cheng Calvin P W, Chan Sandra S M, Mak Arthur D P, Chan Wai Chi, Cheng Sheung Tak, Shi Lin, Wang Defeng, Lam Linda Chiu-Wa

机构信息

Department of Psychiatry, Tai Po Hospital, 9 Chuen On Road, Tai Po, Hong Kong.

Department of Psychiatry, The Chinese University of Hong Kong, Rm G25, G/F, Multi-center, Tai Po Hospital, 9 Chuen On Road, Tai Po, Hong Kong.

出版信息

Trials. 2015 Oct 24;16:479. doi: 10.1186/s13063-015-0999-0.

Abstract

BACKGROUND

There has been longstanding interesting in cognitive training for older adults with cognitive impairment. In this study, we will investigate the effects of working memory training, and explore augmentation strategies that could possibly consolidate the effects in older adults with mild neurocognitive disorder. Transcranial direct current stimulation (tDCS) has been demonstrated to affect the neuronal excitability and reported to enhance memory performance. As tDCS may also modulate cognitive function through changes in neuroplastic response, it would be adopted as an augmentation strategy for working memory training in the present study.

METHODS/DESIGN: This is a 4-week intervention double-blind randomized controlled trial (RCT) of tDCS. Chinese older adults (aged 60 to 90 years) with mild neurocognitive disorder due to Alzheimer's disease (DSM-5 criteria) would be randomized into a 4-week intervention of either tDCS-working memory (DCS-WM), tDCS-control cognitive training (DCS-CC), and sham tDCS-working memory (WM-CD) groups. The primary outcome would be working memory test - the n-back task performance and the Chinese version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). Secondary outcomes would be test performance of specific cognitive domains and mood. Intention-to-treat analysis would be carried out. Changes of efficacy indicators with time and intervention would be tested with mixed effect models.

DISCUSSION

This study adopts the theory of neuroplasticity to evaluate the potential cognitive benefits of non-invasive electrical brain stimulation, working memory training and dual stimulation in older adults at risk of cognitive decline. It would also examine the tolerability, program adherence and adverse effects of this novel intervention. Information would be helpful for further research of dementia prevention studies.

TRIAL REGISTRATION

ChiCTR-TRC- 14005036 Date of registration: 31 July 2014.

摘要

背景

长期以来,认知训练一直是认知障碍老年人关注的焦点。在本研究中,我们将调查工作记忆训练的效果,并探索可能巩固轻度神经认知障碍老年人训练效果的强化策略。经颅直流电刺激(tDCS)已被证明可影响神经元兴奋性,并据报道能提高记忆表现。由于tDCS也可能通过神经可塑性反应的变化来调节认知功能,因此在本研究中将其作为工作记忆训练的强化策略。

方法/设计:这是一项为期4周的tDCS双盲随机对照试验(RCT)。符合阿尔茨海默病(DSM-5标准)导致轻度神经认知障碍的中国老年人(年龄60至90岁)将被随机分为4周干预组,分别接受tDCS-工作记忆(DCS-WM)、tDCS-对照认知训练(DCS-CC)和假tDCS-工作记忆(WM-CD)组。主要结局指标将是工作记忆测试——n-back任务表现以及中文版阿尔茨海默病评估量表——认知分量表(ADAS-Cog)。次要结局指标将是特定认知领域的测试表现和情绪。将进行意向性分析。使用混合效应模型测试疗效指标随时间和干预的变化。

讨论

本研究采用神经可塑性理论来评估非侵入性脑电刺激、工作记忆训练和双重刺激对有认知衰退风险的老年人潜在的认知益处。它还将研究这种新型干预的耐受性、方案依从性和不良反应。这些信息将有助于痴呆症预防研究的进一步开展。

试验注册

ChiCTR-TRC-14005036 注册日期:2014年7月31日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/03a1/4619532/d07273e97dc9/13063_2015_999_Fig1_HTML.jpg

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