Wilkinson Gwenllian, Sasegbon Ayodele, Smith Craig J, Bath Philip M, Hamdy Shaheen
Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Nottingham University Hospitals NHS Trust, Stroke, Nottingham, UK.
Cerebellum. 2025 Mar 26;24(3):74. doi: 10.1007/s12311-025-01823-0.
Post-stroke dysphagia (PSD) is common and associated with poor outcomes. We aimed to explore the feasibility, safety, and proof of concept of cerebellar rTMS in patients with sub-acute PSD. We intended to recruit 48 participants with PSD. Randomised to: (i) sham treatment twice-daily for five days, (ii) cerebellar rTMS daily for three days, and (iii) cerebellar rTMS twice-daily for five days (1:1:1). Participants were blinded to treatment group. Primary outcomes were feasibility, safety, and functional outcome intake scale (FOIS), dysphagia severity rating scale (DSRS), and feeding status scale (FSS) at two weeks. However, due to lower-than-expected enrolment, the active rTMS groups were combined. We recruited 14 participants in total, (mean 68 years, 57% female). Due to the time-limited funding period, recruitment was adversely affected by the COVID-19 pandemic. DSRS and FSS trended lower in the combined active rTMS groups at two weeks, i.e. less swallowing impairment. However, at death/discharge FOIS was higher/better (mean, (standard deviation)), 4.0 (2.1) vs. 1.8 (1.0) (p = 0.032) with active TMS, with trends to lower/better DSRS and FSS. There was no difference in the acceptability of treatment between groups. High-intensity (n = 5) vs. low-intensity (n = 5) cerebellar rTMS was associated with lower DSRS 3.0 (1.4) vs. 9.4 (2.7) and FSS 0.6 (0.5) vs. 1.6 (0.5) at 2 weeks, and DSRS 3.0 (1.4) vs. 9.0 (3.7) at hospital discharge or death. Cerebellar rTMS is a feasible ward-based treatment for reducing swallowing impairment. Although enrolment was lower than desired, there was evidence for proof of concept, particularly for high-intensity cerebellar rTMS. Larger studies are warranted.
中风后吞咽困难（PSD）很常见，且与不良预后相关。我们旨在探讨小脑重复经颅磁刺激（rTMS）治疗亚急性PSD患者的可行性、安全性及概念验证。我们计划招募48名PSD患者。随机分为：（i）假治疗，每天两次，共五天；（ii）小脑rTMS，每天一次，共三天；（iii）小脑rTMS，每天两次，共五天（1:1:1）。参与者对治疗组情况不知情。主要结局指标为两周时的可行性、安全性、功能结局摄入量表（FOIS）、吞咽困难严重程度评定量表（DSRS）及进食状态量表（FSS）。然而，由于入组人数低于预期，将积极rTMS组合并。我们共招募了14名参与者（平均68岁，57%为女性）。由于资金期限有限，招募受到了新冠疫情的不利影响。两周时，合并的积极rTMS组的DSRS和FSS呈下降趋势，即吞咽障碍减轻。然而，在死亡/出院时，积极TMS组的FOIS更高/更好（均值，（标准差）），分别为4.0（2.1）和1.8（1.0）（p = 0.032），DSRS和FSS有下降/改善趋势。各组间治疗的可接受性无差异。高强度（n = 5）与低强度（n = 5）小脑rTMS在两周时与较低的DSRS相关，分别为3.0（1.4）和9.4（2.7），FSS分别为0.6（0.5）和1.6（0.5），在出院或死亡时DSRS分别为3.0（1.4）和9.0（3.7）。小脑rTMS是一种可行的基于病房的减少吞咽障碍的治疗方法。尽管入组人数低于预期，但有概念验证的证据，特别是对于高强度小脑rTMS。有必要开展更大规模的研究。
