Chen Xi, Zhu Jiayi, Bai Wenjing, Li Xueling, Yang Min, Wang Jianxiong, Yu Jihua, Jian Rui
Department of Rehabilitation, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.
Rehabilitation Medicine and Engineering Key Laboratory of Luzhou, Luzhou, Sichuan, China.
BMJ Open. 2025 Apr 27;15(4):e097034. doi: 10.1136/bmjopen-2024-097034.
Dysphagia is one of the common complications of stroke. The use of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) to stimulate the suprahyoid motor cortex, which has been an evidence-based treatment method for dysphagia. Intermittent theta burst stimulation (iTBS) is a newer type of rTMS. There are few studies comparing iTBS with 10 Hz rTMS in the treatment of post-stroke dysphagia (PSD). Therefore, our study describes the rationale and design of a randomised controlled trial to evaluate the effects of iTBS versus 10 Hz rTMS on swallowing function, serum indexes and functional fMRI in patients with PSD.
Fifty participants with PSD will be randomly assigned to the iTBS group (n=25) or the rTMS group (n=25). iTBS group: three 50 Hz pulses, repeated at 5 Hz, 100% intensity threshold, 600 pulses/time and sham rTMS. rTMS group: 10 Hz pulse, 100% intensity threshold, 1000 pulses/time and sham iTBS. The stimulation sites will be the suprahyoid motor cortex of affected hemisphere, once a day, 5 times a week for 4 weeks. Swallowing function and serum indexes will be evaluated at baseline, second week of treatment, fourth week of treatment and 4 weeks after the end of treatment. The fMRI will be evaluated at baseline and in the fourth week of treatment.
This study was reviewed and approved by the Ethics Committee of the Affiliated Hospital of Southwest Medical University (number: KY2023406). The findings will be published in peer-reviewed journals and presented at academic conferences.
ChiCTR2400079679.
吞咽困难是中风的常见并发症之一。使用高频（10Hz）重复经颅磁刺激（rTMS）刺激舌骨上运动皮层，这已成为一种基于证据的吞咽困难治疗方法。间歇性theta爆发刺激（iTBS）是一种新型的rTMS。很少有研究比较iTBS与10Hz rTMS在治疗中风后吞咽困难（PSD）方面的效果。因此，我们的研究描述了一项随机对照试验的基本原理和设计，以评估iTBS与10Hz rTMS对PSD患者吞咽功能、血清指标和功能磁共振成像的影响。
50名PSD患者将被随机分配到iTBS组（n = 25）或rTMS组（n = 25）。iTBS组：三个50Hz脉冲，以5Hz重复，强度阈值为100%，每次600个脉冲，并进行假rTMS。rTMS组：10Hz脉冲，强度阈值为100%，每次1000个脉冲，并进行假iTBS。刺激部位将是患侧半球的舌骨上运动皮层，每天一次，每周5次，共4周。在基线、治疗第二周、治疗第四周和治疗结束后4周评估吞咽功能和血清指标。功能磁共振成像将在基线和治疗第四周进行评估。
本研究已通过西南医科大学附属医院伦理委员会的审查和批准（编号：KY2023406）。研究结果将发表在同行评审期刊上，并在学术会议上展示。
ChiCTR2400079679。
