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首页> 外文期刊>British journal of neurosurgery >Implementing novel trial methods to evaluate surgery for essential tremor
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Implementing novel trial methods to evaluate surgery for essential tremor

机译：实施新颖的试验方法来评估原发性震颤的手术

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Introduction. Deep brain stimulation (DBS) can provide dramatic essential tremor (ET) relief, however no Class I evidence exists. Materials and methods. Analysis methods: I) traditional cohort analysis; II) N-of-1 single patient randomised control trial and III) signal-to-noise (S/N) analysis. 20 DBS electrodes in ET patients were switched on and off for 3-min periods. Six pairs of on and off periods in each case, with the pair order determined randomly. Tremor severity was quantified with tremor evaluator and patient was blinded to stimulation. Patients also stated whether they perceived the stimulation to be on after each trial. Results. I) Mean end-of-trial tremor severity 0.84 out of 10 on, 6.62 Off, t = - 13.218, p < 00005. II) N-of-1:60% of cases had 12 correct perceptions (p = 0001), 20% had 11 correct perceptions (p = 0013). Ill) S/N: > 80% tremor reduction occurred in 99/114 'On' trials (87%), and 3/114 'Off' trials (3%). S/N ratio for 80% improvement with DBS versus spontaneous improvement was 487,757-to-1. Conclusions. DBS treatment effect on ET is too large for bias to be a plausible explanation. Formal N-of-1 trial design, and S/N ratio method for presenting results, allows this to be demonstrated convincingly where conventional randomised controlled trials are not possible. Classification of evidence. This study is the first to provide Class I evidence for the efficacy of DBS for ET.
机译：介绍。深度脑刺激（DBS）可以提供戏剧性的基本震颤（ET）缓解，但是尚无I类证据。材料和方法。分析方法：I）传统队列分析; II）N对1的单人随机对照试验和III）信噪比（S / N）分析。 ET患者中的20个DBS电极在3分钟内一直处于打开和关闭状态。每种情况下有六对导通和截止周期，并且成对顺序是随机确定的。使用震颤评估器对震颤的严重程度进行量化，并对患者不知情。患者还陈述了他们是否在每次试验后都感觉到了刺激。结果。 I）平均试验末期震颤严重度0.8（满分10分，6.62 Off，t =-13.218，p <00005。）II）N分之1：60％的患者有12个正确的感知力（p = 0001）， 20％的人有11个正确的感知力（p = 0013）。 I / S：99/114“开”试验（87％）和3/114“关”试验（3％）使震颤减少> 80％。与自发改善相比，DBS改善80％时的信噪比为487757对1。结论DBS处理对ET的影响太大，不能引起偏见，这可能是一个合理的解释。正式的N比1试验设计和用于显示结果的信噪比方法，可以在无法进行常规随机对照试验的情况下令人信服地证明这一点。证据分类。这项研究是第一个为DBS对ET效力提供I类证据的研究。

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