Department of Neurology, University of Chicago Medicine, Chicago, Illinois, USA.
Speech and Swallowing Section, Department of Surgery, University of Chicago Medicine, Chicago, Illinois, USA.
J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):989-994. doi: 10.1136/jnnp-2018-318060. Epub 2018 Apr 13.
OBJECTIVE: To evaluate the long-term effect of 60 Hz stimulation of the subthalamic nucleus (STN) on dysphagia, freezing of gait (FOG) and other motor symptoms in patients with Parkinson's disease (PD) who have FOG at the usual 130 Hz stimulation. METHODS: This is a prospective, sequence randomised, crossover, double-blind study. PD patients with medication refractory FOG at 130 Hz stimulation of the STN were randomised to the sequences of 130 Hz, 60 Hz or deep brain stimulation off to assess swallowing function (videofluoroscopic evaluation and swallowing questionnaire), FOG severity (stand-walk-sit test and FOG questionnaire) and motor function (Unified PD Rating Scale, Part III motor examination (UPDRS-III)) at initial visit (V1) and follow-up visit (V2, after being on 60 Hz stimulation for an average of 14.5 months), in their usual medications on state. The frequency of aspiration events, perceived swallowing difficulty and FOG severity at 60 Hz compared with 130 Hz stimulation at V2, and their corresponding changes at V2 compared with V1 at 60 Hz were set as primary outcomes, with similar comparisons in UPDRS-III and its subscores as secondary outcomes. RESULTS: All 11 enrolled participants completed V1 and 10 completed V2. We found the benefits of 60 Hz stimulation compared with 130 Hz in reducing aspiration frequency, perceived swallowing difficulty, FOG severity, bradykinesia and overall axial and motor symptoms at V1 and persistent benefits on all of them except dysphagia at V2, with overall decreasing efficacy when comparing V2 to V1. CONCLUSIONS: The 60 Hz stimulation, when compared with 130 Hz, has long-term benefits on reducing FOG, bradykinesia and overall axial and motor symptoms except dysphagia, although the overall benefits decrease with long-term use. CLINICAL TRIAL REGISTRATION: NCT02549859; Pre-results.
目的:评估在接受常规 130Hz 丘脑底核(STN)刺激的出现冻结步态(FOG)的帕金森病(PD)患者中,60Hz 刺激对吞咽困难和 FOG 及其他运动症状的长期影响。
方法:这是一项前瞻性、序列随机、交叉、双盲研究。将 STN 130Hz 刺激药物难治性 FOG 的 PD 患者随机分为 130Hz、60Hz 或深部脑刺激(off)序列,以评估吞咽功能(视频透视评估和吞咽问卷)、FOG 严重程度(站立-行走-坐下试验和 FOG 问卷)和运动功能(统一帕金森病评定量表,第三部分运动检查(UPDRS-III)),在初始就诊(V1)和随访就诊(V2,在以 60Hz 刺激平均 14.5 个月后,在常规药物状态下)。V2 时 60Hz 刺激与 130Hz 刺激相比,吞咽困难的严重程度、吞咽困难的感知和 FOG 严重程度,以及 V2 时与 V1 相比的相应变化,作为主要结局,UPDRS-III 及其亚量表的类似比较作为次要结局。
结果:所有 11 名入组患者均完成了 V1 检查,10 名患者完成了 V2 检查。我们发现与 130Hz 刺激相比,60Hz 刺激具有降低吞咽困难频率、吞咽困难感知、FOG 严重程度、运动迟缓以及整体轴性和运动症状的益处,除了吞咽困难外,V2 时这些益处持续存在,与 V1 相比,V2 时的整体疗效下降。
结论:与 130Hz 相比,60Hz 刺激在长期减少 FOG、运动迟缓以及整体轴性和运动症状(除了吞咽困难)方面具有长期益处,尽管随着长期使用,整体益处会下降。
临床试验注册:NCT02549859;预结果。
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