Importance It is unknown if there is a difference in outcome in asleep vs awake deep brain stimulation (DBS) of the subthalamic nucleus for advanced Parkinson disease. Objective To determine the difference in adverse effects concerning cognition, mood, and behavior between awake and asleep DBS favoring the asleep arm of the study. Design, Setting, and Participants This study was a single-center prospective randomized open-label blinded end point clinical trial. A total of 187 persons with Parkinson disease were referred for DBS between May 2015 to March 2019. Analysis took place from January 2016 to January 2020. The primary outcome follow-up visit was conducted 6 months after DBS. Interventions Bilateral subthalamic nucleus DBS was performed while the patient was asleep (under general anesthesia) in 1 study arm and awake in the other study arm. Both arms of the study used a frame-based intraoperative microelectrode recording technique to refine final target placement of the DBS lead. Main Outcomes and Measures The primary outcome variable was the between-group difference in cognitive, mood, and behavioral adverse effects as measured by a composite score. The secondary outcomes included the Movement Disorders Society Unified Parkinson's Disease Rating Scale, the patient assessment of surgical burden and operative time. Results A total of 110 patients were randomized to awake (local anesthesia; n = 56; mean [SD] age, 60.0 (7.4) years; 40 [71%] male) or to asleep (general anesthesia; n = 54; mean [SD] age, 61.3 [7.9] years; 38 [70%] male) DBS surgery. The 6-month follow-up visit was completed by 103 participants. The proportion of patients with adverse cognitive, mood, and behavioral effects on the composite score was 15 of 52 (29%) after awake and 11 of 51 (22%) after asleep DBS (odds ratio, 0.7 [95% CI, 0.3-1.7]). There was no difference in improvement in the off-medication Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Examination scores between groups (awake group: mean [SD], -27.3 [17.5] points; asleep group: mean [SD], -25.3 [14.3] points; mean difference, -2.0 [95% CI, -8.1 to 4.2]). Asleep surgery was experienced as less burdensome by patients and was 26 minutes shorter than awake surgery. Conclusions and Relevance There was no difference in the primary outcome of asleep vs awake DBS. Future large randomized clinical trials should examine some of the newer asleep based DBS technologies because this study was limited to frame-based microelectrode-guided procedures. Trial Registration trialregister.nl Identifier: NTR5809.

中文翻译：

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微电极记录引导的帕金森病深部脑刺激中的全身麻醉与局部麻醉：GALAXY 随机临床试验。

重要性 尚不清楚晚期帕金森病的丘脑底核的睡眠与清醒深部脑刺激 (DBS) 的结果是否存在差异。目的 确定清醒和睡眠 DBS 在认知、情绪和行为方面的不利影响差异，有利于研究的睡眠组。设计、设置和参与者 本研究是一项单中心前瞻性随机开放标签盲法终点临床试验。2015 年 5 月至 2019 年 3 月期间，共有 187 名帕金森病患者被转诊接受 DBS。分析于 2016 年 1 月至 2020 年 1 月进行。主要结果随访在 DBS 后 6 个月进行。干预 在一个研究组中患者处于睡眠状态（在全身麻醉下）并在另一个研究组中清醒时进行双侧丘脑底核 DBS。研究的两个分支都使用了基于框架的术中微电极记录技术来改进 DBS 引线的最终目标位置。主要结果和测量 主要结果变量是通过综合评分衡量的认知、情绪和行为不良反应的组间差异。次要结果包括运动障碍协会统一帕金森病评定量表、患者对手术负担和手术时间的评估。结果 共有 110 名患者被随机分配到清醒组（局部麻醉；n = 56；平均 [SD] 年龄，60.0 (7.4) 岁；40 [71%] 男性）或睡眠组（全身麻醉；n = 54；平均 [SD] SD] 年龄，61.3 [7.9] 岁；38 [70%] 男性）DBS 手术。103 名参与者完成了为期 6 个月的随访。有不良认知、情绪、对综合评分的行为影响是清醒后 52 人中有 15 人 (29%) 和睡着 DBS 后 51 人中有 11 人 (22%) (优势比, 0.7 [95% CI, 0.3-1.7])。停药运动障碍协会统一帕金森病评定量表运动检查评分在各组之间没有改善差异（清醒组：平均 [SD]，-27.3 [17.5] 分；睡眠组：平均 [SD]，-25.3 [14.3] 分；平均差，-2.0 [95% CI，-8.1 至 4.2]）。患者感觉睡眠手术的负担较轻，并且比清醒手术短 26 分钟。结论和相关性 睡眠与清醒 DBS 的主要结果没有差异。未来的大型随机临床试验应该检查一些较新的基于睡眠的 DBS 技术，因为这项研究仅限于基于框架的微电极引导程序。