针灸治疗中风后吞咽困难的神经可塑性和疗效:fMRI 和 DTI 随机对照试验方案。

IF 3.3 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Wei Liu, Wenyi Ge, Qi Zhao, Xiaonong Fan, Yibing Li, Hongbo Jia, Kangchen Lei, Songjiao Li, Li Li, Yuzheng Du, Jian Liu, Yan Shen, Sha Yang, Shu Wang, Xize Jia, Lei Ren, Jihua Liu
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引用次数: 0

摘要

背景:吞咽困难是急性中风的常见并发症,与死亡率和发病率的增加有关。针灸作为一种在中国广泛使用的吞咽疗法,被最近的荟萃分析和指南认为是治疗脑卒中后吞咽困难(PSD)的有效疗法。利用静息态功能磁共振成像(rs-fMRI)和弥散张量成像(DTI)可以探索针刺治疗PSD后区域自发神经活动的变化、脑区之间的功能关系和白质连接模式。本试验旨在评估针灸治疗 PSD 的疗效,并通过神经影像学探索其中心机制:这项随机对照试验将招募 40 名 PSD 患者。所有患者将按 1:1 的比例随机分配到真针(RA)组或假针(SA)组。所有患者将在核磁共振扫描室立即接受针灸治疗,然后接受为期四周的长期针灸治疗。主要结果为 rs-fMRI 和 DTI 指标,这些指标将在即时和长期针灸治疗后进行评估。次要结果是评估疗效的量表,包括功能性口腔摄入量表(FOIS)、吞水试验(WST)、吞咽生活质量问卷(SWAL-QOL)和美国国立卫生研究院卒中量表(NIHSS)。此外,还将评估麻省总医院针刺感觉量表(M-MASS)修订版和 fMRI 感觉记录表:本方案介绍了一项随机、单盲试验的设计,该试验将评估针灸治疗 PSD 的疗效并探索其神经可塑性。该试验将加深我们对针灸治疗PSD临床价值的认识,并初步探究针灸的时间-剂量效应机制:试验注册号:中国临床试验注册中心 ( www.chictr.org.cn ) ChiCTR2300067480。本研究于2023年1月9日注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The neural plasticity and efficacy of acupuncture for post-stroke dysphagia: protocol for a randomized controlled trial with fMRI and DTI.

Background: Dysphagia, a common complication of acute stroke, is associated with increased mortality and morbidity. Acupuncture, a widely used swallowing therapy in China, has been suggested as an effective therapy for treating Post-Stroke Dysphagia (PSD) by recent meta-analyses and guidelines. The use of resting-state functional Magnetic Resonance Imaging (rs-fMRI) and Diffusion Tensor Imaging (DTI) could explore the change of regional spontaneous neural activity, functional relationships between brain regions, and white matter connectivity patterns after acupuncture intervention for PSD. This trial aims to evaluate the efficacy of acupuncture treatment for PSD and explore its central mechanism by neuroimaging.

Methods/design: This randomized controlled trial will recruit 40 PSD patients. All patients will be randomized to either the Real Acupuncture (RA) or Sham Acupuncture (SA) group by a ratio of 1:1. All patients will receive immediate acupuncture treatment in the MRI scanning room, followed by four weeks of long-term acupuncture treatment. The primary outcomes are the rs-fMRI and DTI indicators, which will be evaluated after the immediate and long-term acupuncture treatment. The secondary outcomes are the scales that assess the efficacy, including the Functional Oral Intake Scale (FOIS), Water Swallowing Test (WST), Swallowing Quality Of Life Questionnaire (SWAL-QOL), and National Institute of Health Stroke Scale (NIHSS). The modified version of the Massachusetts General Hospital Acupuncture Sensation Scale (M-MASS) and fMRI sensation record table will also be evaluated.

Discussion: This protocol presents the design of a randomized, single-blind trial that will evaluate the efficacy and explore the neural plasticity of acupuncture treatment for PSD. This trial will deepen our insight into the clinical value of acupuncture for PSD and initially probe into the time-dosage-effect mechanism of acupuncture.

Trial registration numbers: Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2300067480. This study was registered on 9th January 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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