Data_Sheet_1_Reduced Programming Time and Strong Symptom Control Even in Chronic Course Through Imaging-Based DBS Programming.docx

Objectives: Deep brain stimulation (DBS) programming is based on clinical response testing. Our clinical pilot trial assessed the feasibility of image-guided programing using software depicting the lead location in a patient-specific anatomical model.
Methods: Parkinson's disease patients with subthalamic nucleus-DBS were randomly assigned to standard clinical-based programming (CBP) or anatomical-based (imaging-guided) programming (ABP) in an 8-week crossover trial. Programming characteristics and clinical outcomes were evaluated.
Results: In 10 patients, both programs led to similar motor symptom control (MDS-UPDRS III) after 4 weeks (medicationOFF/stimulationON; CPB: 18.27 ± 9.23; ABP: 18.37 ± 6.66). Stimulation settings were not significantly different, apart from higher frequency in the baseline program than CBP (p = 0.01) or ABP (p = 0.003). Time spent in a program was not significantly different (CBP: 86.1 ± 29.82%, ABP: 88.6 ± 29.0%). Programing time was significantly shorter (p = 0.039) with ABP (19.78 ± 5.86 min) than CBP (45.22 ± 18.32).
Conclusion: Image-guided DBS programming in PD patients drastically reduces programming time without compromising symptom control and patient satisfaction in this small feasibility trial.

研究目的：脑深部电刺激（Deep brain stimulation, DBS）的程控目前依托临床反应测试开展。本临床预试验旨在评估采用可显示患者特异性解剖模型中电极位置的软件，实施影像引导式程控的可行性。
研究方法：招募罹患帕金森病且接受丘脑底核-脑深部电刺激（subthalamic nucleus-DBS, STN-DBS）的患者，采用8周交叉试验设计，将其随机分为标准临床导向程控组（clinical-based programming, CBP）与基于解剖结构（影像引导）的程控组（anatomical-based programming, ABP）。对程控特征与临床结局进行评估。
研究结果：共纳入10例患者，两组方案在术后4周的运动症状控制效果（药物撤用/刺激开启状态下的帕金森病运动障碍学会统一评分量表第三部分（MDS-UPDRS III）评分）无显著差异（CBP组：18.27±9.23；ABP组：18.37±6.66）。刺激参数方面，除基线方案的刺激频率显著高于CBP组（p=0.01）与ABP组（p=0.003）外，其余参数均无显著组间差异。两组患者使用对应程控方案的时长无显著差异（CBP组：86.1±29.82%；ABP组：88.6±29.0%）。但ABP组的程控时长（19.78±5.86 min）显著短于CBP组（45.22±18.32 min，p=0.039）。
研究结论：在这项小型可行性预试验中，针对帕金森病患者的影像引导脑深部电刺激程控可大幅缩短程控时长，且不会削弱症状控制效果与患者满意度。