A Prospective Trial of Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for Essential Tremor: Results at the 2-Year Follow-up
A Prospective Trial of Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for Essential Tremor: Results at the 2-Year Follow-up
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DOI：
10.1002/ana.25126
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发表时间：
2018-01-01
影响因子：
11.2
通讯作者：
Elias, W. Jeffrey
中科院分区：
文献类型：
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作者：
Chang, Jin Woo;Park, Chang Kyu;Elias, W. Jeffrey
目的：磁共振引导聚焦超声（MRgFUS）最近已被调查作为一种新的治疗方式原发性震颤（ET），但该程序的持久性尚未得到评估。本研究报告的结果在2年后的后续MRgFUS丘脑切开术ET。方法：共76例中重度ET，谁没有回应至少两个试验的药物治疗，参加了原来的随机研究，单侧丘脑切开术，并使用震颤的临床评定量表进行评估。67例患者继续进入研究的开放标签扩展期，并监测2年。9例患者在2年内被排除，例如，因为替代治疗，如脑深部电刺激（n=3）或热损伤不充分（n=1）。然而，在每个随访periods.Results：平均手震颤评分在基线（19.8 +/- 4.9; 76例患者）改善了55%，在6个月（8.6 +/- 4.5; 75例患者）。震颤评分较基线的改善在1年（53%; 8.9 +/- 4.8; 70例患者）和2年（56%; 8.8 +/- 5.0; 67例患者）时持续。同样，基线残疾评分（16.4 +/- 4.5; 76例患者）在6个月时改善了64%（5.4 +/- 4.7; 75例患者）。这种改善在1年（5.4 +/- 5.3; 70例患者）和2年（6.5 +/- 5.0; 67例患者）时也持续存在。感觉异常和步态障碍是1年时最常见的不良反应-各有10例患者观察到，另有5例患者发生神经系统不良反应。在随访期间，无不良事件恶化，其中2例消退。2年时没有新的迟发性并发症。解释：MRgFUS丘脑切开术治疗ET后的震颤抑制稳定维持2年。治疗后不会出现潜在或延迟的并发症。
Objective: Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated. This study reports results at a 2-year follow-up after MRgFUS thalamotomy for ET.Methods: A total of 76 patients with moderate-to-severe ET, who had not responded to at least two trials of medical therapy, were enrolled in the original randomized study of unilateral thalamotomy and evaluated using the clinical rating scale for tremor. Sixty-seven of the patients continued in the open-label extension phase of the study with monitoring for 2 years. Nine patients were excluded by 2 years, for example, because of alternative therapy such as deep brain stimulation (n=3) or inadequate thermal lesioning (n=1). However, all patients in each follow-up period were analyzed.Results: Mean hand tremor score at baseline (19.8 +/- 4.9; 76 patients) improved by 55% at 6 months (8.6 +/- 4.5; 75 patients). The improvement in tremor score from baseline was durable at 1 year (53%; 8.9 +/- 4.8; 70 patients) and at 2 years (56%; 8.8 +/- 5.0; 67 patients). Similarly, the disability score at baseline (16.4 +/- 4.5; 76 patients) improved by 64% at 6 months (5.4 +/- 4.7; 75 patients). This improvement was also sustained at 1 year (5.4 +/- 5.3; 70 patients) and at 2 years (6.5 +/- 5.0; 67 patients). Paresthesias and gait disturbances were the most common adverse effects at 1 year-each observed in 10 patients with an additional 5 patients experiencing neurological adverse effects. None of the adverse events worsened over the period of follow-up, and 2 of these resolved. There were no new delayed complications at 2 years.Interpretation: Tremor suppression after MRgFUS thalamotomy for ET is stably maintained at 2 years. Latent or delayed complications do not develop after treatment.