Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses.
Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses.
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DOI：
10.1111/ner.12397
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发表时间：
2016-06
期刊：
影响因子：
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通讯作者：
Okun MS
中科院分区：
文献类型：
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作者：
Akbar U;Raike RS;Hack N;Hess CW;Skinner J;Martinez-Ramirez D;DeJesus S;Okun MS
有证据表明，非传统程控可能会改善运动障碍的脑深部电刺激（DBS）治疗。主要目的是评估在单次办公室访视中测试帕金森病（PD）和原发性震颤（ET）受试者的几种非常规设置的耐受性的可行性。次要目的是探索潜在有效性信号，并评估植入式脉冲发生器（IPG）的能量需求。开发了一个自定义固件（FW）应用程序，并迅速上传到8名PD和3名ET受试者的IPG，允许输送几种非传统DBS设置，包括窄脉宽、方形双相脉冲和不规则脉冲模式。使用标准临床评定量表和几种客观指标来比较假手术、临床最佳和非常规设置的运动结局。在传统的办公室环境中进行盲态和随机化测试。总体而言，非常规设置耐受良好。在这些条件下，还可以使用临床评定量表而不是客观测量来检测DBS反应的临床相关差异。与临床最佳设置相比，一些非常规设置似乎提供了类似的益处（例如，窄脉冲宽度）和其它较小的益处。此外，结果表明，方形双相脉冲可能会带来更大的好处。没有与输送非常规设置相关的非预期IPG效率劣势。在传统的办公室环境中使用对照研究设计来急性筛选非传统DBS设置是可行的。简单的IPG固件升级可提供更多DBS程控选项以优化治疗。窄脉冲和双相脉冲的潜在优势值得进一步研究。
Evidence suggests that nonconventional programming may improve deep brain stimulation (DBS) therapy for movement disorders. The primary objective was to assess feasibility of testing the tolerability of several nonconventional settings in Parkinson's disease (PD) and essential tremor (ET) subjects in a single office visit. Secondary objectives were to explore for potential efficacy signals and to assess the energy demand on the implantable pulse‐generators (IPGs). A custom firmware (FW) application was developed and acutely uploaded to the IPGs of eight PD and three ET subjects, allowing delivery of several nonconventional DBS settings, including narrow pulse widths, square biphasic pulses, and irregular pulse patterns. Standard clinical rating scales and several objective measures were used to compare motor outcomes with sham, clinically‐optimal and nonconventional settings. Blinded and randomized testing was conducted in a traditional office setting. Overall, the nonconventional settings were well tolerated. Under these conditions it was also possible to detect clinically‐relevant differences in DBS responses using clinical rating scales but not objective measures. Compared to the clinically‐optimal settings, some nonconventional settings appeared to offer similar benefit (e.g., narrow pulse widths) and others lesser benefit. Moreover, the results suggest that square biphasic pulses may deliver greater benefit. No unexpected IPG efficiency disadvantages were associated with delivering nonconventional settings. It is feasible to acutely screen nonconventional DBS settings using controlled study designs in traditional office settings. Simple IPG FW upgrades may provide more DBS programming options for optimizing therapy. Potential advantages of narrow and biphasic pulses deserve follow up.