针刺治疗遗忘型轻度认知障碍的情景记忆疗效：一项多中心随机对照临床试验研究方案。
Effect of acupuncture on episodic memory for amnesia-type mild cognitive impairment: study protocol of a multicenter, randomized, controlled trial.
机构信息
Department of Rehabilitation Medicine, The People's Hospital of Baoan Shenzhen, Shenzhen, China.
College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.
出版信息
BMC Complement Med Ther. 2023 Jul 28;23(1):268. doi: 10.1186/s12906-023-04059-9.
BACKGROUND
Amnesic mild cognitive impairment (aMCI) is the main subtype of mild cognitive impairment (MCI) and has the highest risk of conversion to Alzheimer's disease (AD) among all MCI subtypes. Episodic memory impairment is the early cognitive impairment of aMCI, which has become an important target for AD prevention. Previous clinical evidence has shown that acupuncture can improve the cognitive ability of MCI patients. This experiment aimed to observe the efficacy and neural mechanism of TiaoshenYizhi acupuncture on the episodic memory of patients with aMCI.
METHODS
In this multicenter, parallel-group, double-blind, randomized controlled trial, 360 aMCI participants will be recruited from six subcenters and randomly assigned to the acupuncture group, sham acupuncture group, and control group. The acupuncture group will receive TiaoshenYizhi (TSYZ) acupuncture, the sham acupuncture group will use streitberger sham acupuncture, and the control group will only receive free health education. Participants in the two acupuncture groups will receive real acupuncture treatment or placebo acupuncture three times per week, 24 sessions over 8 consecutive weeks. The primary outcome will be global cognitive ability. Secondary outcomes will be a specific cognitive domain, including episodic memory and execution ability, electroencephalogram, and functional magnetic resonance imaging data. Outcomes will be measured at baseline and the fourth and eighth weeks after randomization. Repeated measurement analysis of variance and a mixed linear model will be used to observe the intervention effect.
DISCUSSION
The protocol will give a detailed procedure to the multicenter clinical trial to further evaluate the efficacy and neural mechanism of TiaoshenYizhi acupuncture on episodic memory in patients with aMCI. From this research, we expect to provide clinical evidence for early aMCI management.
TRIAL REGISTRATION
http://www.chictr.org.cn/edit.aspx?pid=142612&htm=4 , identifier: ChiCTR2100054009.
背景
遗忘型轻度认知障碍（aMCI）是轻度认知障碍（MCI）的主要亚型，在所有 MCI 亚型中，向阿尔茨海默病（AD）转化的风险最高。情景记忆障碍是 aMCI 的早期认知障碍，已成为 AD 预防的重要靶点。既往临床证据表明，针刺可以改善 MCI 患者的认知能力。本实验旨在观察调神益智针刺对 aMCI 患者情景记忆的疗效及神经机制。
方法
本多中心、平行分组、双盲、随机对照试验将从 6 个分中心招募 360 名 aMCI 参与者，随机分为针刺组、假针刺组和对照组。针刺组接受调神益智针刺，假针刺组采用 Streitberger 假针刺，对照组仅接受免费健康教育。两组针刺组每周接受 3 次真针刺或假针刺治疗，共 24 次，连续 8 周。主要结局指标为整体认知能力。次要结局指标为特定认知域，包括情景记忆和执行能力、脑电图和功能磁共振成像数据。在随机分组后第 4 周和第 8 周测量结局。采用重复测量方差分析和混合线性模型观察干预效果。
讨论
方案将为多中心临床试验提供详细过程，以进一步评估调神益智针刺对 aMCI 患者情景记忆的疗效和神经机制。从这项研究中，我们期望为早期 aMCI 管理提供临床证据。
试验注册
http://www.chictr.org.cn/edit.aspx?pid=142612&htm=4 ，标识符：ChiCTR2100054009。
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