经颅直流电刺激对轻度或重度神经认知障碍患者认知康复的安全性和可行性：一项随机假刺激对照试验研究

Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study.

作者信息

Inagawa Takuma, Yokoi Yuma, Narita Zui, Maruo Kazushi, Okazaki Mitsutoshi, Nakagome Kazuyuki

机构信息

Department of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Kodaira, Japan.

Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.

出版信息

Front Hum Neurosci. 2019 Sep 6;13:273. doi: 10.3389/fnhum.2019.00273. eCollection 2019.

DOI:10.3389/fnhum.2019.00273

PMID:31555109

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6742726/

Abstract

INTRODUCTION

Transcranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with mild or major neurocognitive disorders. This study aims to assess the safety and efficacy of tDCS during cognitive training on cognitive functioning in patients with mild or major neurocognitive disorders.

METHODS

This study was primarily a single arm for safety, secondary a two-arm, parallel, randomized, and sham-controlled trial for potential efficacy. Patients with mild or major neurocognitive disorders were recruited. The participants and raters were blinded to the group assignment. The participants in the active arm received tDCS (anodal; F3, cathodal, Fp2, 2A, 20 min) twice daily for five consecutive days, whereas those in the sham arm received the same amount of sham-tDCS. Calculation and reading tasks were conducted in both arms as a form of cognitive intervention for 20 min during tDCS. The primary outcome was the attrition rate during the trial in the active arm, which is expected to be less than 10%. The secondary outcomes were the between-group differences of adjusted means for several cognitive scales from baseline to post-intervention and follow-up.

RESULTS

Twenty patients [nine women (45%)], with a mean (standard deviation) age of 76.1 years participated; nine patients (45%) with minor neurocognitive disorders and 11 (55%) with major neurocognitive disorders were randomized, and 19 of them completed the trial. The attrition rate in the active arm was 0%, with no serious adverse events. Further, in the Intention-to-Treat analysis, patients in the active arm showed no statistically significant improvement compared with those who received the sham in the mean change scores of the mini-mental state examination [0.41; 95% CI (-1.85; 2.67) at day five, 1.08; 95% CI (-1.31; 3.46) at follow-up] and Alzheimer's disease assessment scale - cognition subscale [1.61; 95% CI (-4.2; 0.98) at day 5, 0.36; 95%CI (-3.19; 2.47) at follow-up].

CONCLUSION

These findings suggest that tDCS is safe and tolerable but causes no statistically significant cognitive effects in patients with mild or major neurocognitive disorders. Additional large-scale, well-designed clinical trials are warranted to evaluate the cognitive effects of tDCS as an augmentation to cognitive training.

CLINICAL TRIAL REGISTRATION

www.ClinicalTrials.gov, identifier NCT03050385.

摘要

引言

经颅直流电刺激（tDCS）是一种用于改善轻度或重度神经认知障碍患者认知功能的潜在新策略。本研究旨在评估tDCS在认知训练期间对轻度或重度神经认知障碍患者认知功能的安全性和有效性。

方法

本研究主要是一项单臂安全性试验，其次是一项双臂、平行、随机、假对照试验以评估潜在疗效。招募了轻度或重度神经认知障碍患者。参与者和评估者对分组情况不知情。干预组参与者连续五天每天接受两次tDCS（阳极；F3，阴极，Fp2，2mA，20分钟），而假刺激组参与者接受等量的假tDCS。在tDCS期间，两组均进行计算和阅读任务作为认知干预形式，持续20分钟。主要结局是干预组在试验期间的失访率，预计低于10%。次要结局是从基线到干预后及随访期间几个认知量表调整均值的组间差异。

结果

20例患者[9名女性（45%）]参与，平均（标准差）年龄为76.1岁；9例（45%）为轻度神经认知障碍患者，11例（55%）为重度神经认知障碍患者被随机分组，其中19例完成试验。干预组失访率为0%，无严重不良事件。此外，在意向性分析中，干预组患者在简易精神状态检查的平均变化得分方面与接受假刺激的患者相比无统计学显著改善[第5天为0.41；95%CI（-1.85；2.67），随访时为1.08；95%CI（-1.31；3.46）]，在阿尔茨海默病评估量表-认知分量表方面也无改善[第5天为1.61；95%CI（-4.2；0.98），随访时为0.36；95%CI（-3.19；2.47）]。