tDCS 结合虚拟现实对中风后认知障碍的影响:随机对照试验研究方案。

IF 3.3 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Xiao-Ping Cheng, Zhao-Di Wang, Yue-Zhu Zhou, Li-Qiong Zhan, Di Wu, Li-Li Xie, Kai-Liang Luo, Jin-Peng He, Wei Lin, Jun Ni, Lan Lv, Xin-Yuan Chen
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引用次数: 0

摘要

背景:脑卒中后认知障碍(PSCI)不仅会增加患者的死亡率和残疾程度,还会对运动功能和日常活动能力产生不利影响。目前针对认知障碍的治疗方法缺乏针对性,主要依赖于药物治疗和传统认知疗法,并辅以一系列有限的工具。经颅直流电刺激(tDCS)和虚拟现实(VR)训练在改善 PSCI 患者的认知能力方面均有疗效。以前对各种情况的研究结果表明,实施一种结合了经颅直流电刺激和虚拟现实(tDCS - VR)的治疗方案可能会取得更好的效果。尽管如此,据我们所知,目前尚未开展过将 tDCS 和 VR 结合用于 PSCI 康复的临床研究。因此,本研究旨在探讨 tDCS - VR 对 PSCI 康复的影响:这项为期 4 周的单中心随机临床试验方案将招募 200 名患者,将他们随机分配到四个组中的一组:A 组(tDCS + VR)、B 组(tDCS + 假 VR)、C 组(假 tDCS + VR)、D 组(假 tDCS + 假 VR)。所有四组都将接受传统的认知康复训练。主要结果测量采用迷你精神状态检查(MMSE)。次要结果测量包括蒙特利尔认知评估、额叶评估电池、时钟绘制测试、数字跨度测试、逻辑记忆测试和改良巴特尔指数。此外,用于诊断和治疗语言障碍的 S-YYZ-01 仪器可评估受试者的语言功能。对所有结果测量进行为期四周的干预前和干预后评估。采用功能性近红外光谱(fNIRS)观察大脑皮层中氧合血红蛋白(HbO)、脱氧血红蛋白(HbR)和总血红蛋白(HbT)的变化:我们的假设是,tDCS-VR疗法与单独的tDCS或VR干预不同,它可以增强PSCI患者的认知功能、语言能力和日常生活技能,同时增强额叶皮质的活动。这项随机研究旨在为tDCS-VR组合作为一种安全、高效的PSCI康复方法的实际实施提供坚实的理论基础和科学证据支持:试验注册:Chictr.org.cn Identifier:ChiCTR2300070580。注册日期:2023年4月17日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effect of tDCS combined with virtual reality for post-stroke cognitive impairment: a randomized controlled trial study protocol.

Background: Post-stroke cognitive impairment (PSCI) not only increases patient mortality and disability, but also adversely affects motor function and the ability to perform routine daily activities. Current therapeutic approaches for, PSCI lack specificity, primarily relying on and medication and traditional cognitive therapy supplemented by a limited array of tools. Both transcranial direct current stimulation (tDCS) and virtual reality (VR) training have demonstrated efficacy in improving cognitive performance among PSCI patients. Previous findings across various conditions suggest that implementing a therapeutic protocol combining tDCS and VR (tDCS - VR) may yield superior in isolation. Despite this, to our knowledge, no clinical investigation combining tDCS and VR for PSCI rehabilitation has been conducted. Thus, the purpose of this study is to explore the effects of tDCS - VR on PSCI rehabilitation.

Methods: This 4-week, single-center randomized clinical trial protocol will recruit 200 patients who were randomly assigned to one of four groups: Group A (tDCS + VR), Group B (tDCS + sham VR), Group C (sham tDCS + VR), Group D (sham tDCS + sham VR). All four groups will receive conventional cognitive rehabilitation training. The primary outcome measurement utilizes the Mini-Mental State Examination (MMSE). Secondary outcome measures include the Montreal Cognitive Assessment, Frontal Assessment Battery, Clock Drawing Test, Digital Span Test, Logic Memory Test, and Modified Barthel Index. Additionally, S-YYZ-01 apparatus for diagnosis and treating language disorders assesses subjects' speech function. Pre- and post-four-week intervention assessments are conducted for all outcome measures. Functional near-infrared spectroscopy (fNIRS) is employed to observe changes in oxygenated hemoglobin (HbO), deoxy-hemoglobin (HbR), and total hemoglobin (HbT) in the cerebral cortex.

Discussion: Our hypothesis posits that the tDCS - VR therapy, in opposed to individual tDCS or VR interventions, could enhance cognitive function, speech ability and daily living skills in PSCI patients while concurrently augmenting frontal cortical activity. This randomized study aims to provide a robust theoretical foundation supported by scientific evidence for the practical implementation of the tDCS - VR combination as a secure and efficient PSCI rehabilitation approach.

Trial registration: Chictr.org.cn Identifier: ChiCTR2300070580. Registered on 17th April 2023.

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来源期刊
BMC Complementary Medicine and Therapies
BMC Complementary Medicine and Therapies INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
6.10
自引率
2.60%
发文量
300
审稿时长
19 weeks
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