Effect and Neuroimaging Mechanism of Electroacupuncture for Vascular Cognitive Impairment No Dementia: Study Protocol for a Randomized, Assessor-Blind, Controlled Clinical Trial
Effect and Neuroimaging Mechanism of Electroacupuncture for Vascular Cognitive Impairment No Dementia: Study Protocol for a Randomized, Assessor-Blind, Controlled Clinical Trial
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DOI：
10.1155/2020/7190495
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发表时间：
2020-02-26
影响因子：
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通讯作者：
Chen, Lidian
中科院分区：
文献类型：
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作者：
Lin, Ruizhu;Huang, Jia;Chen, Lidian
无痴呆的血管性认知障碍（VCIND）在不干预的情况下很可能发展为血管性痴呆（VD）.电针治疗VCIND的临床疗效已被证实。然而，电针治疗VCIND的神经影像学机制尚未阐明。本试验旨在为电针治疗VCIND患者的疗效和神经影像学机制提供坚实的证据。这项正在进行的研究是一项评估者设盲、平行组、随机对照试验。将从宁夏医科大学总医院招募140例符合条件的受试者，随机分为电针组（EA）和对照组（CG）。所有受试者将接受基本治疗，CG参与者将接受每周一次的健康教育。除了基本的治疗和健康教育外，EA组的参与者将接受每周5次的治疗，共40次，为期8周。本研究的主要结果是蒙特利尔认知评估（莫卡），次要结果是听觉言语学习测试（AVLT），Stroop颜色命名条件（STROOP），Rey-Osterrieth复杂图形测试和静息状态功能磁共振成像（rs-fMRI）。将在基线和干预8周时评估所有结局指标。将在每次访视时进行不良事件的医学摘要。本试验的结果将证明电针治疗VCIND的疗效和神经影像学机制，从而支持电针治疗作为VCIND治疗的理想选择。本试验于2018年7月28日在中国临床试验注册中心注册（）。
Vascular cognitive impairment no dementia (VCIND) is likely to develop into vascular dementia (VD) without intervention. The clinical efficacy of electroacupuncture (EA) for VCIND has been previously demonstrated. However, the neuroimaging mechanism of EA for VCIND has not been elucidated clearly. This trial is designed to provide solid evidence for the efficacy and neuroimaging mechanism of EA treatment for patients with VCIND. This ongoing study is an assessor-blind, parallel-group, randomized controlled trial. 140 eligible subjects will be recruited from the General Hospital of Ningxia Medical University and randomized into either the electroacupuncture (EA) group or the control group (CG). All subjects will receive basic treatment, and participants in the CG will receive health education performed weekly. Except for basic treatment and health education, participants in the EA group will receive treatment 5 times per week for a total of 40 sessions over 8 weeks. The primary outcome in this study is Montreal Cognitive Assessment (MoCA), and the secondary outcomes are Auditory Verbal Learning Test (AVLT), Stroop color-naming condition (STROOP), Rey-Osterrieth Complex Graphics Testing, and resting-state functional magnetic resonance imaging (rs-fMRI). All of the outcome measures will be assessed at baseline and 8 weeks of intervention. The medical abstraction of adverse events will be done at each visit. The results of this trial will demonstrate the efficacy and neuroimaging mechanism of EA treatment for VCIND, thus supporting EA treatment as an ideal choice for VCIND treatment. The trial was registered at the Chinese Clinical Trial Registry on 28 July 2018 ().