针刺治疗脑卒中后吞咽障碍的神经可塑性和疗效：基于 fMRI 和 DTI 的随机对照试验方案。

The neural plasticity and efficacy of acupuncture for post-stroke dysphagia: protocol for a randomized controlled trial with fMRI and DTI.

机构信息

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.

National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.

出版信息

BMC Complement Med Ther. 2024 Oct 4;24(1):357. doi: 10.1186/s12906-024-04657-1.

DOI:10.1186/s12906-024-04657-1

PMID:39367391

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11451215/

Abstract

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.

摘要

背景

吞咽困难是急性脑卒中的常见并发症，与死亡率和发病率增加有关。针刺作为中国广泛应用的吞咽治疗方法，最近的荟萃分析和指南表明，其对治疗脑卒中后吞咽障碍（PSD）有效。静息态功能磁共振成像（rs-fMRI）和弥散张量成像（DTI）的应用可以探索针刺干预 PSD 后区域自发性神经活动、脑区功能关系和白质连接模式的变化。本试验旨在通过神经影像学评估针刺治疗 PSD 的疗效，并探索其中枢机制。

方法/设计：这是一项随机对照试验，将招募 40 名 PSD 患者。所有患者将按 1:1 的比例随机分为真针刺（RA）组或假针刺（SA）组。所有患者将在 MRI 扫描室接受即时针刺治疗，然后进行四周的长期针刺治疗。主要结局指标是 rs-fMRI 和 DTI 指标，将在即时和长期针刺治疗后进行评估。次要结局指标是评估疗效的量表，包括功能性口腔摄入量表（FOIS）、饮水试验（WST）、吞咽生活质量问卷（SWAL-QOL）和国立卫生研究院卒中量表（NIHSS）。还将评估改良版麻省总医院针刺感觉量表（M-MASS）和 fMRI 感觉记录表。