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.

Abstract

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.