Department of Clinical Medicine - Nuclear Medicine and PET Center, Aarhus University, Aarhus, Denmark.
Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.
Mov Disord Clin Pract. 2024 Aug;11(8):927-947. doi: 10.1002/mdc3.14143. Epub 2024 Jun 20.
BACKGROUND: Parkinson's Disease (PD) is a progressive neurological disorder that results in potentially debilitating mobility deficits. Recently, spinal cord stimulation (SCS) has been proposed as a novel therapy for PD gait disorders. The highest levels of evidence remain limited for SCS. OBJECTIVES: In this systematic review and narrative synthesis, the literature was searched using combinations of key phrases indicating spinal cord stimulation and PD. METHODS: We included pre-clinical studies and all published clinical trials, case reports, conference abstracts as well as protocols for ongoing clinical trials. Additionally, we included trials of SCS applied to atypical parkinsonism. RESULTS: A total of 45 human studies and trials met the inclusion criteria. Based on the narrative synthesis, a number of knowledge gaps and future avenues of potential research were identified. This review demonstrated that evidence for SCS is currently not sufficient to recommend it as an evidence-based therapy for PD related gait disorders. There remain challenges and significant barriers to widespread implementation, including issues regarding patient selection, effective outcome selection, stimulation location and mode, and in programming parameter optimization. Results of early randomized controlled trials are currently pending. SCS is prone to placebo, lessebo and nocebo as well as blinding effects which may impact interpretation of outcomes, particularly when studies are underpowered. CONCLUSION: Therapies such as SCS may build on current evidence and be shown to improve specific gait features in PD. Early negative trials should be interpreted with caution, as more evidence will be required to develop effective methodologies in order to drive clinical outcomes.
背景:帕金森病(PD)是一种进行性神经障碍,可导致严重的运动障碍。最近,脊髓刺激(SCS)已被提议作为治疗 PD 步态障碍的新疗法。SCS 的最高证据水平仍然有限。
目的:在这项系统评价和叙述性综合中,使用了表示脊髓刺激和 PD 的关键词组合来搜索文献。
方法:我们纳入了临床前研究和所有已发表的临床试验、病例报告、会议摘要以及正在进行的临床试验方案。此外,我们还纳入了 SCS 应用于非典型帕金森病的试验。
结果:共有 45 项人体研究和试验符合纳入标准。基于叙述性综合,确定了一些知识空白和未来潜在研究的方向。本综述表明,目前 SCS 的证据不足以推荐其作为 PD 相关步态障碍的循证治疗方法。广泛实施仍面临挑战和重大障碍,包括患者选择、有效结果选择、刺激部位和模式以及编程参数优化等问题。早期随机对照试验的结果目前仍在等待中。SCS 容易受到安慰剂、假性刺激和无反应的影响,以及盲法效应的影响,这可能会影响结果的解释,尤其是当研究缺乏效力时。
结论:SCS 等疗法可能会基于现有证据,显示出改善 PD 特定步态特征的效果。早期的阴性试验应谨慎解释,因为需要更多的证据来制定有效的方法,以推动临床结果。
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