用于帕金森病脑深部电刺激的交互式移动应用程序（MAP DBS）：一项开放标签、多中心、随机、对照临床试验。
Interactive mobile application for Parkinson's disease deep brain stimulation (MAP DBS): An open-label, multicenter, randomized, controlled clinical trial.
机构信息
Scientific Computing and Imaging Institute, University of Utah, Salt Lake City, UT, USA; Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.
Division of Biostatistics, Institute for Health & Equity, Medical College of Wisconsin, Milwaukee, WI, USA.
出版信息
Parkinsonism Relat Disord. 2023 Apr;109:105346. doi: 10.1016/j.parkreldis.2023.105346. Epub 2023 Mar 16.
INTRODUCTION
Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease (PD), but its efficacy is tied to DBS programming, which is often time consuming and burdensome for patients, caregivers, and clinicians. Our aim is to test whether the Mobile Application for PD DBS (MAP DBS), a clinical decision support system, can improve programming.
METHODS
We conducted an open-label, 1:1 randomized, controlled, multicenter clinical trial comparing six months of SOC standard of care (SOC) to six months of MAP DBS-aided programming. We enrolled patients between 30 and 80 years old who received DBS to treat idiopathic PD at six expert centers across the United States. The primary outcome was time spent DBS programming and secondary outcomes measured changes in motor symptoms, caregiver strain and medication requirements.
RESULTS
We found a significant reduction in initial visit time (SOC: 43.8 ± 28.9 min n = 37, MAP DBS: 27.4 ± 13.0 min n = 35, p = 0.001). We did not find a significant difference in total programming time between the groups over the 6-month study duration. MAP DBS-aided patients experienced a significantly larger reduction in UPDRS III on-medication scores (-7.0 ± 7.9) compared to SOC (-2.7 ± 6.9, p = 0.01) at six months.
CONCLUSION
MAP DBS was well tolerated and improves key aspects of DBS programming time and clinical efficacy.
简介
深部脑刺激（DBS）是治疗帕金森病（PD）的有效方法，但疗效取决于 DBS 编程，这对患者、护理人员和临床医生来说通常既耗时又费力。我们旨在测试移动应用程序用于 PD DBS（MAP DBS）——一种临床决策支持系统，是否可以改善编程。
方法
我们进行了一项开放标签、1:1 随机、对照、多中心临床试验，比较了六个月的标准护理（SOC）与六个月的 MAP DBS 辅助编程。我们招募了年龄在 30 至 80 岁之间的患者，他们在美国六个专家中心接受 DBS 治疗特发性 PD。主要结果是 DBS 编程时间，次要结果测量运动症状、护理人员压力和药物需求的变化。
结果
我们发现初始就诊时间有显著减少（SOC：43.8±28.9 分钟 n=37，MAP DBS：27.4±13.0 分钟 n=35，p=0.001）。我们没有发现两组在 6 个月研究期间总编程时间的显著差异。MAP DBS 辅助患者在 6 个月时药物治疗 UPDRS III 评分的降低幅度明显大于 SOC 组（-7.0±7.9 与 -2.7±6.9，p=0.01）。
结论
MAP DBS 耐受性良好，可改善 DBS 编程时间和临床疗效的关键方面。
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