Objective: Deep brain stimulation (DBS) is a safe and established treatment for essential tremor (ET) and several other movement disorders. One approach to improving DBS therapy is adaptive DBS (aDBS), in which stimulation parameters are modulated in real time based on biofeedback from either external or implanted sensors. Previously tested systems have fallen short of translational applicability due to the requirement for patients to continuously wear the necessary sensors or processing devices, as well as privacy and security concerns. Approach: We designed and implemented a translation-ready training data collection system for fully implanted aDBS. Two patients chronically implanted with electrocorticography strips over the hand portion of M1 and DBS probes in the ipsilateral ventral intermediate nucleus of the thalamus for treatment of ET were recruited for this study. Training was conducted using a translation-ready distributed training procedure, allowing a substantially higher degree of control over data collection than previous works. A linear classifier was trained using this system, biased towards activating stimulation in accordance with clinical considerations. Main Results: The clinically relevant average false negative rate, defined as fraction of time during which stimulation dropped below 1/2 clinical levels during movement epochs, was 0.036. Tremor suppression, calculated through analysis of gyroscope data, was 33.2% more effective on average with aDBS than with continuous DBS. During a period of free movement with aDBS, one patient reported a slight paresthesia; patients noticed no difference in treatment efficacy between systems. Significance: Here is presented the first translation-ready training procedure for a fully embedded aDBS control system for MDs and one of the first examples of such a system in ET, adding to the consensus that fully implanted aDBS systems are sufficiently mature for broader deployment in treatment of movement disorders.

中文翻译：

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自由移动的原发性震颤患者的全植入自适应深部脑刺激

目的：深部脑刺激（DBS）是针对原发性震颤（ET）和其他几种运动障碍的安全可靠的治疗方法。改善DBS治疗的一种方法是自适应DBS（aDBS），其中基于来自外部或植入传感器的生物反馈来实时调节刺激参数。由于要求患者连续佩戴必要的传感器或处理设备，以及隐私和安全问题，因此先前测试的系统在翻译上的适用性不足。方法：我们为完全植入的aDBS设计并实施了翻译准备型培训数据收集系统。该研究招募了两名长期在丘脑同侧腹中核的M1和DBS探针的手部上长期植入皮质描记片的患者。培训是使用可翻译的分布式培训程序进行的，与以前的工作相比，可以大大提高对数据收集的控制程度。使用该系统训练了线性分类器，并根据临床考虑偏向于激活刺激。主要结果：临床相关的平均假阴性率是0.036，定义为刺激在运动时期下降到1/2临床水平以下的时间百分比。通过陀螺仪数据分析计算出的震颤抑制效果，与连续DBS相比，使用aDBS的平均效果要高33.2％。在aDBS自由活动期间，一名患者报告有轻微的感觉异常。患者注意到系统之间的治疗效果没有差异。启示：这里介绍了针对MD的完全嵌入式aDBS控制系统的第一个翻译准备培训程序，以及ET中此类系统的第一个示例，这进一步增加了一个共识，即完全植入的aDBS系统已经足够成熟，可以广泛部署。运动障碍的治疗。