Effects of intermittent theta burst stimulation versus repetitive transcranial magnetic stimulation on post-stroke dysphagia in hospitalised patients: study protocol for a prospective, randomised controlled trial.

Introduction: 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.

Methods And Analysis: 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.

Ethics And Dissemination: 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.

Trial Registration Number: ChiCTR2400079679.