Changchun University of Chinese Medicine, No.1035 Boshuo Road, Nanguan District, Changchun, Jilin, 130117, China.
Trials. 2021 Nov 25;22(1):847. doi: 10.1186/s13063-021-05842-0.
Diabetic cognitive impairment (DCI) is a serious chronic complication caused by diabetes. The pathogenesis of DCI is complex, but brain nerve injury and brain nerve cell apoptosis are important pathological changes. Multimodal brain imaging is one of the most important techniques to study the neural mechanism of the brain. For the clinical treatment of DCI, there is no effective targeted Western medicine and a lack of clear drug intervention methods. Therefore, there is an urgent need to find effective complementary and alternative methods and clarify their mechanism. This research seeks to explore the multimodal brain imaging effect of "Adjust Zang-fu and Arouse Spirit" electroacupuncture for DCI.
This clinical research will be a randomized, sham-controlled pilot trial. Eligible participants will be randomly assigned to the intervention group (n = 60) and the control group (n = 30). The intervention group will be divided into the "Adjust Zang-fu and Arouse Spirit" electroacupuncture group (n = 30) and sham electroacupuncture group (n = 30). All participants will continue to receive routine hypoglycemic therapy. The treatment period is the same in both groups. The primary outcomes include functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS), Montreal Cognitive Assessment Scale (MoCA), and Clinical Dementia Rating (CDR). The secondary outcomes include blood glucose and blood lipid tests, Instrumental Activities of Daily Living Scale (IADL), Hachinski Ischemic Scale (HIS), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Outcomes will be assessed at baseline and before and after treatment, and adverse events will be examined. Inter- and intragroup analyses will be performed.
This randomized controlled study, combined with multimodal brain imaging techniques and a clinical evaluation scale, was designed to explore the mechanism of "Adjust Zang-fu and Arouse Spirit" electroacupuncture in improving the central nervous system in DCI.
Chinese Clinical Trial Registration ChiCTR2000040268 . Registered on 26 November 2020.
糖尿病认知障碍（DCI）是糖尿病引起的一种严重的慢性并发症。DCI 的发病机制复杂，但脑神经损伤和脑神经元细胞凋亡是重要的病理变化。多模态脑成像技术是研究脑神经机制的最重要技术之一。对于 DCI 的临床治疗，目前尚无有效的靶向西药，缺乏明确的药物干预方法。因此，迫切需要寻找有效的补充和替代方法，并阐明其机制。本研究旨在探讨“调脏腑、醒神”电针对 DCI 的多模态脑成像影响。
本临床研究将采用随机、假对照的初步试验。符合条件的参与者将被随机分配到干预组（n = 60）和对照组（n = 30）。干预组将分为“调脏腑、醒神”电针组（n = 30）和假电针组（n = 30）。所有参与者将继续接受常规降糖治疗。两组的治疗期相同。主要结局包括功能磁共振成像（fMRI）、磁共振波谱（MRS）、蒙特利尔认知评估量表（MoCA）和临床痴呆评定量表（CDR）。次要结局包括血糖和血脂检测、工具性日常生活活动量表（IADL）、哈金斯基缺血量表（HIS）、焦虑自评量表（SAS）和抑郁自评量表（SDS）。在基线和治疗前后进行评估，并检查不良事件。将进行组间和组内分析。
本随机对照研究结合多模态脑成像技术和临床评价量表，旨在探讨“调脏腑、醒神”电针对改善 DCI 中枢神经系统的作用机制。
中国临床试验注册中心 ChiCTR2000040268 。注册于 2020 年 11 月 26 日。
