Supplementary Material for: A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson’s Disease

<b><i>Objective:</i></b> Asleep deep brain stimulation (DBS) for Parkinson’s disease (PD) is being performed more frequently; however, motor outcomes and safety of asleep DBS have never been assessed in a prospective randomized trial. <b><i>Methods:</i></b> We conducted a prospective, randomized, noncomparative trial to assess the motor outcomes of asleep DBS. Leads were implanted in the subthalamic nucleus (STN) according to probabilistic stereotactic coordinates with a surgical robot under O-arm^© imaging guidance under either general anesthesia without microelectrode recordings (MER) (20 patients, asleep group) or local anesthesia with MER and clinical testing (9 patients, awake group). <b><i>Results:</i></b> The mean motor improvement rates on the Unified Parkinson’s Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication were 52.3% (95% CI: 45.4–59.2%) in the asleep group and 47.0% (95% CI: 23.8–70.2%) in the awake group, 6 months after surgery. Except for a subcutaneous hematoma, we did not observe any complications related to the surgery. Three patients (33%) in the awake group and 8 in the asleep group (40%) had at least one side effect potentially linked with neurostimulation. <b><i>Conclusions:</i></b> Owing to its randomized design, our study supports the hypothesis that motor outcomes after asleep STN-DBS in PD may be noninferior to the standard awake procedure.

**研究目标**：睡眠状态下深部脑刺激（Deep Brain Stimulation, DBS）用于帕金森病（Parkinson’s Disease, PD）的临床应用日益增多，但目前尚无前瞻性随机试验对其运动功能疗效与安全性进行评估。

**研究方法**：本研究开展一项前瞻性随机非比较试验，以评估睡眠状态下DBS的运动功能疗效。研究采用手术机器人结合O-arm^©影像引导，依据概率立体定向坐标将电极植入丘脑底核（Subthalamic Nucleus, STN）；分组方案为：采用无微电极记录（Microelectrode Recordings, MER）的全身麻醉方案的20例患者（睡眠组），以及采用联合微电极记录与临床测试的局部麻醉方案的9例患者（清醒组）。

**研究结果**：术后6个月，在未服药状态下，刺激开启与关闭时的统一帕金森病评定量表第三部分（Unified Parkinson’s Disease Rating Scale Part III, UPDRS-3）平均运动改善率，睡眠组为52.3%（95%置信区间：45.4%~59.2%），清醒组为47.0%（95%置信区间：23.8%~70.2%）。除1例皮下血肿外，未观察到其他与手术相关的并发症。清醒组3例患者（33%）、睡眠组8例患者（40%）出现至少1种可能与神经刺激相关的不良反应。

**研究结论**：得益于随机化研究设计，本研究支持以下假说：帕金森病患者接受睡眠状态下丘脑底核DBS后的运动功能疗效，不劣于标准清醒手术方案。