Investigation of the improvement of swallowing function with low-frequency pulse waves or interference waves delivered via cervical electrical stimulation in patients with Parkinson's disease: A randomized controlled study protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-20 DOI:10.1016/j.conctc.2025.101463

Masahiro Nakamori , Ryotaro Matsuyama , Megumi Toko , Hidetada Yamada , Yuki Hayashi , Kohei Yoshikawa , Mineka Yoshikawa , Toshikazu Nagasaki , Yoshitaka Shimizu , Hirofumi Maruyama

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引用次数: 0

Abstract

Parkinson's disease (PD) is associated with a high rate of swallowing dysfunction, which may lead to aspiration pneumonia. This randomized controlled trial aims to investigate the effects of cervical electrical stimulation interventions (interferential current or low-frequency pulse wave stimulation) on swallowing dysfunction in patients with PD. The study will include patients with PD with Hoehn–Yahr stages 2–4 and will assess the swallowing function in a multifaceted manner using tools such as the 1 % citric acid cough test, videofluoroscopic swallowing study (VFSS), Functional Oral Intake Scale score, and Eating Assessment Tool-10 score. The primary endpoint is an improvement in the cough reflex, as measured by the citric acid cough test, whereas the secondary endpoints include changes in the swallowing function, including the VFSS, tongue pressure, and salivary substance P levels. Participants will receive 30 min of cervical stimulation daily for 2 weeks. This study also explores the use of novel instruments such as multichannel surface electromyography and electronic stethoscopes for the detailed assessment of swallowing physiology. By investigating these two electrical stimulation techniques, this study seeks to provide insights into the pathophysiology of swallowing dysfunction in PD and to evaluate the efficacy and safety of these interventions.

Trial registration number

jRCTs062240041; pre-results.

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通过颈部电刺激传递低频脉冲波或干扰波改善帕金森病患者吞咽功能的研究：一项随机对照研究方案

帕金森病（PD）与高比例的吞咽功能障碍相关，吞咽功能障碍可能导致吸入性肺炎。本随机对照试验旨在探讨宫颈电刺激干预（干扰电流或低频脉冲波刺激）对PD患者吞咽功能障碍的影响。该研究将纳入Hoehn-Yahr 2-4期PD患者，并将使用1%柠檬酸咳嗽试验、视频透视吞咽研究（VFSS）、功能性口服摄入量表评分和进食评估工具-10评分等工具，以多方面的方式评估吞咽功能。主要终点是咳嗽反射的改善，通过柠檬酸咳嗽试验测量，而次要终点包括吞咽功能的变化，包括VFSS，舌压和唾液P物质水平。参与者将连续两周每天接受30分钟的宫颈刺激。本研究还探讨了使用新的仪器，如多通道表面肌电图和电子听诊器来详细评估吞咽生理学。通过研究这两种电刺激技术，本研究旨在为PD患者吞咽功能障碍的病理生理学提供见解，并评估这些干预措施的有效性和安全性。试验注册号：jrcts062240041；pre-results。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.