The mechanism of Sangdantongluo granule in treating post-stroke spasticity based on multimodal fMRI combined with TMS: Study protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-06-01 DOI:10.1016/j.conctc.2024.101317

Jie Tang , Yao Xie , Rui Fang , Huizhong Tan , Shanshan Zeng , Zan Wen , Xiongxing Sun , Ting Yao , Shiliang Wang , Le Xie , Dahua Wu

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引用次数: 0

Abstract

Introduction

Post-stroke spasticity (PSS) is among the prevalent complications of stroke, greatly affecting motor function recovery and reducing patients' quality of life without timely treatment. Sangdantongluo granule, a modern traditional Chinese patent medicine, has significant clinical efficacy in treating PSS. However, the mechanism of Sangdantongluo granule in treating PSS is still unknown. We designed this study to explore the mechanism of Sangdantongluo granule in treating PSS through multimodal functional magnetic resonance imaging (fMRI) combined with transcranial magnetic stimulation (TMS).

Methods and analysis

In a single-center, randomized, double-blind, parallel placebo-controlled study, 60 PSS patients will be recruited in China and randomly assigned to either the experimental or control groups at a ratio of 1:1. For eight weeks, Sangdantongluo granule or placebo will be utilized for intervention. The main outcome is the Modified Ashworth Scale (MAS), the secondary outcome includes the Fugl-Meyer Assessment Scale-upper Extremity (FMA-UE), National Institute of Health Stroke Scale (NIHSS), and Modified Rankin Scale (mRS), the mechanism measure is the changes in cortical excitability and multimodal fMRI at baseline and after eight weeks.

Ethics and dissemination

This study was approved by the Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine (approval number: [202364]).

Clinical trial registration

Chinese Clinical Trial Registry, identiﬁer: ChiCTR2300074793. Registered on 16 August 2023.

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基于多模态 fMRI 结合 TMS 的桑丹通络颗粒治疗脑卒中后痉挛的机制：研究方案

引言中风后痉挛（PSS）是中风的常见并发症之一，如不及时治疗，会极大地影响患者运动功能的恢复，降低患者的生活质量。现代中成药桑丹通络颗粒在治疗 PSS 方面具有显著的临床疗效。然而，桑丹通络颗粒治疗PSS的机制尚不清楚。我们设计了这项研究，通过多模态功能磁共振成像（fMRI）结合经颅磁刺激（TMS）来探索桑丹通络颗粒治疗PSS的机制。方法与分析在一项单中心、随机、双盲、平行安慰剂对照研究中，我们将在中国招募60名PSS患者，按1:1的比例随机分配到实验组或对照组。在为期八周的时间里，将使用生脉通颗粒或安慰剂进行干预。主要结果为改良阿什沃斯量表（MAS），次要结果包括福格-迈耶评估量表-上肢（FMA-UE）、美国国立卫生研究院卒中量表（NIHSS）和改良兰金量表（mRS），机制测量为基线和八周后大脑皮层兴奋性和多模态fMRI的变化。伦理与传播本研究经湖南省中医药研究院附属医院伦理委员会批准（批准号：[202364]）：ChiCTR2300074793。注册日期：2023 年 8 月 16 日。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.