背景:在医学难治性特发性震颤患者中,单侧磁共振引导聚焦超声丘脑切开术可改善对侧震颤。然而,该程序不能解决同侧症状。
目的:本研究的目的是确定是否可以在可接受的安全性条件下进行双侧丘脑切开术,其益处大于不良反应。
方法:我们进行了前瞻性,单臂,原发性震颤患者第二侧磁共振引导聚焦超声丘脑切开术的单盲2期试验。随访3个月。主要结果是生活质量相对于基线的变化,以及这个问题的答案:“鉴于你现在所知道的,你能再治疗第二面吗?”次要结果包括震颤,步态,演讲,和不利影响。
结果:分析了10例患者。这项研究符合两个主要结果,干预导致3个月时生活质量的临床显着改善(原发性震颤的平均生活质量评分差异,19.7;95CI,8.0-31.4;P=0.004),所有患者报告他们将选择再次接受第二侧治疗。所有患者震颤均有明显改善。七个经历了轻微的不良反应,包括2例短暂的步态障碍和跌倒,1伴有构音障碍和吞咽困难,和1在3个月时持续存在轻度吞咽困难。
结论:分期双侧磁共振引导聚焦超声丘脑切开术的安全性与单侧丘脑切开术相似,可改善特发性震颤患者的震颤和生活质量。为了验证这些发现,需要在3期试验中进行长期随访和持续累积。©2021国际帕金森与运动障碍协会。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.