ImportanceUnilateral magnetic resonance imaging (MRI)–guided focused ultrasound subthalamotomy (FUS-STN) improves cardinal motor features among patients with asymmetrical Parkinson disease (PD). The feasibility of bilateral FUS-STN is as yet unexplored.ObjectiveTo assess the safety and effectiveness of staged bilateral FUS-STN to treat PD.Design, Setting, and ParticipantsThis prospective, open-label, case series study was conducted between June 18, 2019, and November 7, 2023, at HM-CINAC, Puerta del Sur University Hospital, Madrid, Spain, and included 6 patients with PD who had been treated with unilateral FUS-STN contralateral to their most affected body side and whose parkinsonism on the untreated side had progressed and was not optimally controlled with medication.InterventionStaged bilateral FUS-STN.Main Outcomes and MeasuresPrimary outcomes were assessed 6 months after the second treatment and included safety (incidence and severity of adverse events after second treatment) and effectiveness in terms of motor change (measured with the Movement Disorders Society Unified Parkinson’s Disease Rating Scale part III [MDS-UPDRS III]) in the off-medication state (ie, after at least 12 hours of antiparkinsonian drug withdrawal) compared with baseline (ie, prior to the first side ablation). Secondary outcomes included motor change in patients in the on-medication state (ie, after usual antiparkinsonian medication intake), motor complications (measured with the MDS-UPDRS IV), daily living activities (measured with the MDS-UPDRS I-II), quality of life (measured with the 39-item Parkinson’s Disease Questionnaire), change in dopaminergic treatment, patient’s global impression of change (measured with the Global Impression of Change [PGI-C] scale), and long-term (24-month) follow-up.ResultsOf 45 patients previously treated with unilateral FUS-STN, 7 were lost to follow-up, and 4 were excluded due to adverse events. Of the remaining 34 patients, 6 (median age at first FUS-STN, 52.6 years [IQR, 49.0-57.3 years]; 3 women [50%]) experienced progression of parkinsonism on the untreated body side and were included. At the time of the first FUS-STN, patients’ median duration of disease was 5.7 years (IQR, 4.7-7.3 years). The median time between procedures was 3.2 years (IQR, 1.9-3.5 years). After the second FUS-STN, 4 patients presented with contralateral choreic dyskinesia, which resolved by 3 months. Four patients developed speech disturbances, which gradually improved but remained in a mild form for 2 patients at 6 months; 1 patient experienced mild imbalance and dysphagia during the first week after treatment, which subsided by 3 months. No behavioral or cognitive disturbances were found on neuropsychological testing. For patients in the off-medication state, MDS-UPDRS III scores improved by 52.6% between baseline and 6 months after the second FUS-STN (from 37.5 [IQR, 34.2-40.0] to 20.5 [IQR, 8.7-24.0]; median difference, 23.0 [95% CI, 7.0-33.7]; P = .03). The second treated side improved by 64.3% (MDS-UPDRS III score, 17.0 [IQR, 16.0-19.5] prior to the second treatment vs 5.5 [IQR, 3.0-10.2]; median difference, 9.5 [95% CI, 3.2-17.7]; P = .02). After the second procedure, all self-reported PGI-C scores were positive.ConclusionsFindings of this pilot study suggest that staged bilateral FUS-STN was safe and effective for the treatment of PD, although mild but persistent speech-related adverse events were observed among a small number of patients.

中文翻译：

---

分期双侧 MRI 引导聚焦超声丘脑切除术治疗帕金森病

重要性单侧磁共振成像 (MRI) 引导聚焦超声丘脑下部切除术 (FUS-STN) 可改善不对称帕金森病 (PD) 患者的基本运动特征。双侧 FUS-STN 的可行性尚未探索。目的评估分阶段双侧 FUS-STN 治疗 PD 的安全性和有效性。设计、设置和参与者这项前瞻性、开放标签、病例系列研究于 2019 年 6 月 18 日进行，以及 2023 年 11 月 7 日，在西班牙马德里 Puerta del Sur 大学医院的 HM-CINAC，纳入了 6 名 PD 患者，他们在受影响最严重的身体一侧接受了单侧 FUS-STN 治疗，且未经治疗的患者患有帕金森病干预措施分期双侧 FUS-STN。主要结果和措施主要结果在第二次治疗后 6 个月进行评估，包括安全性（第二次治疗后不良事件的发生率和严重程度）和运动方面的有效性停药状态（即抗帕金森病药物停药至少 12 小时后）与基线（即用药前）的变化（使用运动障碍协会统一帕金森病评定量表第 III 部分 [MDS-UPDRS III] 测量）第一侧消融）。次要结局包括患者在服药状态下的运动变化（即服用常规抗帕金森病药物后）、运动并发症（用 MDS-UPDRS IV 测量）、日常生活活动（用 MDS-UPDRS I-II 测量）、生活质量（通过 39 项帕金森病问卷测量）、多巴胺能治疗的变化、患者对变化的总体印象（通过总体变化印象 [PGI-C] 量表测量）和长期（24 个月）结果 45例既往接受单侧FUS-STN治疗的患者中，7例失访，4例因不良事件被排除。其余 34 名患者中，有 6 名（首次 FUS-STN 时的中位年龄，52.6 岁 [IQR，49.0-57.3 岁]；3 名女性 [50%]）在未经治疗的身体一侧经历了帕金森病进展，因此被纳入。第一次 FUS-STN 时，患者的中位病程为 5.7 年（IQR，4.7-7.3 年）。两次手术之间的中位时间为 3.2 年（IQR，1.9-3.5 年）。第二次 FUS-STN 后，4 名患者出现对侧舞蹈运动障碍，3 个月后缓解。 4 名患者出现言语障碍，2 名患者在 6 个月时病情逐渐改善，但仍处于轻度状态； 1例患者在治疗后第一周出现轻度失衡和吞咽困难，3个月后缓解。神经心理学测试未发现行为或认知障碍。对于处于停药状态的患者，MDS-UPDRS III 评分在基线和第二次 FUS-STN 后 6 个月之间提高了 52.6%（从 37.5 [IQR，34.2-40.0] 至 20.5 [IQR，8.7-24.0]；中位数差异，23.0 [95% CI，7.0-33.7]；磷= .03)。第二次治疗侧改善了 64.3%（MDS-UPDRS III 评分，第二次治疗前为 17.0 [IQR，16.0-19.5]，而第二次治疗前为 5.5 [IQR，3.0-10.2]；中位差异为 9.5 [95% CI，3.2-17.7] ];磷= .02)。第二次手术后，所有自我报告的 PGI-C 评分均为阳性。 结论 这项试点研究的结果表明，分阶段双侧 FUS-STN 对于治疗 PD 是安全有效的，尽管在患者中观察到了轻微但持续的言语相关不良事件。少数患者。