Iorio-Morin Christian, Yamamoto Kazuaki, Sarica Can, Zemmar Ajmal, Levesque Mathieu, Brisebois Simon, Germann Jurgen, Loh Aaron, Boutet Alexandre, Elias Gavin J B, Azevedo Paula, Adam Elizabeth, Patel Urmi, Lenis Martha, Kalia Suneil K, Hodaie Mojgan, Fasano Alfonso, Lozano Andres M
Division of Neurosurgery, Department of Surgery, Université de Sherbrooke, Sherbrooke, Québec, Canada.
Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Mov Disord. 2021 Nov;36(11):2653-2662. doi: 10.1002/mds.28716. Epub 2021 Jul 20.
In patients with medically refractory essential tremor, unilateral magnetic resonance-guided focused ultrasound thalamotomy can improve contralateral tremor. However, this procedure does not address ipsilateral symptoms.
The objective of the current study was to determine whether bilateral thalamotomies can be performed with an acceptable safety profile where benefits outweigh adverse effects.
We conducted a prospective, single-arm, single-blinded phase 2 trial of second-side magnetic resonance-guided focused ultrasound thalamotomy in patients with essential tremor. Patients were followed for 3 months. The primary outcome was the change in quality of life relative to baseline, as well as the answer to the question "Given what you know now, would you treat the second side again?". Secondary outcomes included tremor, gait, speech, and adverse effects.
Ten patients were analyzed. The study met both primary outcomes, with the intervention resulting in clinically significant improvement in quality of life at 3 months (mean Quality of Life in Essential Tremor score difference, 19.7; 95%CI, 8.0-31.4; P = 0.004) and all patients reporting that they would elect to receive the second-side treatment again. Tremor significantly improved in all patients. Seven experienced mild adverse effects, including 2 with transient gait impairment and a fall, 1 with dysarthria and dysphagia, and 1 with mild dysphagia persisting at 3 months.
Staged bilateral magnetic resonance-guided focused ultrasound thalamotomy can be performed with a reasonable safety profile similar to that seen with unilateral thalamotomy and improves the tremor and quality of life of patients with essential tremor. Longer-term follow-up and continued accrual in the phase 3 trial will be required to validate these findings. © 2021 International Parkinson and Movement Disorder Society.
在药物难治性特发性震颤患者中，单侧磁共振引导下聚焦超声丘脑切开术可改善对侧震颤。然而，该手术无法解决同侧症状。
本研究的目的是确定双侧丘脑切开术是否可以在获益大于不良反应的可接受安全性范围内进行。
我们对特发性震颤患者进行了一项前瞻性、单臂、单盲的二期磁共振引导下聚焦超声丘脑切开术试验。对患者进行了3个月的随访。主要结局是相对于基线的生活质量变化，以及“鉴于你现在所了解的情况，你会再次治疗另一侧吗？”这个问题的答案。次要结局包括震颤、步态、言语和不良反应。
对10名患者进行了分析。该研究达到了两个主要结局，干预导致3个月时生活质量有临床显著改善（特发性震颤生活质量平均得分差异为19.7；95%CI，8.0 - 31.4；P = 0.004），所有患者均表示会再次选择接受另一侧治疗。所有患者的震颤均有显著改善。7名患者出现轻度不良反应，包括2名有短暂步态障碍和跌倒，1名有构音障碍和吞咽困难，1名在3个月时仍有轻度吞咽困难。
分期双侧磁共振引导下聚焦超声丘脑切开术可以在类似于单侧丘脑切开术的合理安全性范围内进行，并改善特发性震颤患者的震颤和生活质量。需要在三期试验中进行更长时间的随访和持续入组以验证这些发现。© 2021国际帕金森和运动障碍协会。
