Nakamori Masahiro, Matsuyama Ryotaro, Toko Megumi, Yamada Hidetada, Hayashi Yuki, Yoshikawa Kohei, Yoshikawa Mineka, Nagasaki Toshikazu, Shimizu Yoshitaka, Maruyama Hirofumi
Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
Department of Rehabilitation Medicine, Hiroshima University Hospital, Hiroshima, Japan.
Contemp Clin Trials Commun. 2025 Feb 20;44:101463. doi: 10.1016/j.conctc.2025.101463. eCollection 2025 Apr.
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.
jRCTs062240041; pre-results.
帕金森病（PD）与吞咽功能障碍的高发生率相关，这可能导致吸入性肺炎。这项随机对照试验旨在研究颈部电刺激干预（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分期为2-4期的PD患者，并使用1%柠檬酸咳嗽试验、电视荧光吞咽造影检查（VFSS）、功能性经口进食量表评分和进食评估工具-10评分等工具，从多方面评估吞咽功能。主要终点是通过柠檬酸咳嗽试验测量的咳嗽反射改善情况，而次要终点包括吞咽功能的变化，如VFSS、舌压和唾液P物质水平。参与者将每天接受30分钟的颈部刺激，持续2周。本研究还探索使用多通道表面肌电图和电子听诊器等新型仪器对吞咽生理进行详细评估。通过研究这两种电刺激技术，本研究旨在深入了解PD患者吞咽功能障碍的病理生理学，并评估这些干预措施的疗效和安全性。
jRCTs062240041；预结果。
