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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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.