Table_1_Cerebellar Continuous Theta Burst Stimulation for Aphasia Rehabilitation: Study Protocol for a Randomized Controlled Trial.DOCX

BackgroundLanguage recovery is limited in moderate to severe post-stroke aphasia patients. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising tool in improving language dysfunctions caused by post-stroke aphasia, but the treatment outcome is as yet mixed. Considerable evidence has demonstrated the essential involvement of the cerebellum in a variety of language functions, suggesting that it may be a potential stimulation target of TMS for the treatment of post-stroke aphasia. Theta burst stimulation (TBS) is a specific pattern of rTMS with shorter stimulation times and better therapeutic effects. The effect of continuous TBS (cTBS) on the cerebellum in patients with aphasia with chronic stroke needs further exploration.
MethodsIn this randomized, sham-controlled clinical trial, patients (n = 40) with chronic post-stroke aphasia received 10 sessions of real cTBS (n = 20) or sham cTBS (n = 20) over the right cerebellar Crus I+ a 30-min speech-language therapy. The Western Aphasia Battery (WAB) serves as the primary measure of the treatment outcome. The secondary outcome measures include the Boston Diagnostic Aphasia Examination, Boston Naming Test and speech acoustic parameters. Resting-state fMRI data were also obtained to examine treatment-induced changes in functional connectivity of the cerebro-cerebellar network. These outcome measures are assessed before, immediately after, and 12 weeks after cerebellar cTBS intervention.
DiscussionThis protocol holds promise that cerebellar cTBS is a potential strategy to improve language functions in chronic post-stroke aphasia. The resting-state fMRI may explore the neural mechanism underlying the aphasia rehabilitation with cerebellar cTBS.

背景：中度至重度卒中后失语症患者的语言功能恢复效果有限。重复经颅磁刺激（repetitive transcranial magnetic stimulation, rTMS）作为改善卒中后失语症所致语言功能障碍的潜在干预手段已受到广泛关注，但其临床治疗效果仍存在分歧。大量研究证据表明，小脑参与多种语言功能的调控过程，提示其可作为经颅磁刺激治疗卒中后失语症的潜在靶点。θ波爆发刺激（theta burst stimulation, TBS）是一种特殊模式的rTMS，具有刺激时长更短、治疗效果更优的特点。而连续性θ波爆发刺激（continuous TBS, cTBS）针对慢性卒中后失语症患者小脑的治疗效应，仍有待进一步探索。
方法：本研究为一项随机、假对照临床试验，共纳入40例慢性卒中后失语症患者，按1:1比例随机分为两组，分别接受右侧小脑Crus I区的真实cTBS（n=20）或假cTBS（n=20）干预，共完成10个疗程，同时配合30分钟的言语语言治疗。以西方失语症成套测验（Western Aphasia Battery, WAB）作为主要疗效评估指标；次要疗效评估指标包括波士顿诊断性失语症检查、波士顿命名测验以及言语声学参数。此外，采集静息态功能磁共振成像（resting-state fMRI）数据，以探究干预诱导的小脑-大脑功能网络连接变化。所有疗效评估均在小脑cTBS干预前、干预即刻及干预后12周完成。
讨论：本研究方案证实，小脑cTBS有望成为改善慢性卒中后失语症患者语言功能的潜在治疗策略。静息态功能磁共振成像可进一步揭示小脑cTBS用于失语症康复的潜在神经机制。