Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial

Abstract Background 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...

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Autores principales:	Lin Yao, Mengyuan Li, Shunan Sun, Ming Xu, Shuo Yu, Ziyang Zhang, Liying Zhang, Haizhu Zheng, Zhen Zhong, Shiqi Ma, Haipeng Huang, Hongfeng Wang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Electropuncture Diabetic Cognitive Impairment Multimodal brain imaging; Randomized controlled trial Study protocol Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/6eebfcb882bc45ea82d42e6ff1a71cdd
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spelling	oai:doaj.org-article:6eebfcb882bc45ea82d42e6ff1a71cdd2021-11-28T12:28:45ZMultimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial10.1186/s13063-021-05842-01745-6215https://doaj.org/article/6eebfcb882bc45ea82d42e6ff1a71cdd2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05842-0https://doaj.org/toc/1745-6215Abstract Background 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. Methods 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. Discussion 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. Trial registration Chinese Clinical Trial Registration ChiCTR2000040268 . Registered on 26 November 2020Lin YaoMengyuan LiShunan SunMing XuShuo YuZiyang ZhangLiying ZhangHaizhu ZhengZhen ZhongShiqi MaHaipeng HuangHongfeng WangBMCarticleElectropunctureDiabetic Cognitive ImpairmentMultimodal brain imaging; Randomized controlled trialStudy protocolMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Electropuncture Diabetic Cognitive Impairment Multimodal brain imaging; Randomized controlled trial Study protocol Medicine (General) R5-920
spellingShingle	Electropuncture Diabetic Cognitive Impairment Multimodal brain imaging; Randomized controlled trial Study protocol Medicine (General) R5-920 Lin Yao Mengyuan Li Shunan Sun Ming Xu Shuo Yu Ziyang Zhang Liying Zhang Haizhu Zheng Zhen Zhong Shiqi Ma Haipeng Huang Hongfeng Wang Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
description	Abstract Background 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. Methods 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. Discussion 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. Trial registration Chinese Clinical Trial Registration ChiCTR2000040268 . Registered on 26 November 2020
format	article
author	Lin Yao Mengyuan Li Shunan Sun Ming Xu Shuo Yu Ziyang Zhang Liying Zhang Haizhu Zheng Zhen Zhong Shiqi Ma Haipeng Huang Hongfeng Wang
author_facet	Lin Yao Mengyuan Li Shunan Sun Ming Xu Shuo Yu Ziyang Zhang Liying Zhang Haizhu Zheng Zhen Zhong Shiqi Ma Haipeng Huang Hongfeng Wang
author_sort	Lin Yao
title	Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
title_short	Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
title_full	Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
title_fullStr	Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
title_full_unstemmed	Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
title_sort	multimodal brain imaging effect of “adjust zang-fu and arouse spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/6eebfcb882bc45ea82d42e6ff1a71cdd
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Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial

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