Prakash Prarthana, Deuschl Guenther, Ozinga Sarah, Mitchell Kyle T, Cheeran Binith, Larson Paul S, Merola Aristide, Groppa Sergiu, Tomlinson Tucker, Ostrem Jill L
Department of Neurology, UCSF Weill Institute for Neurosciences, Movement Disorder and Neuromodulation Center University of California San Francisco CA USA.
Department of Neurology, Universitatsklinikum Schleswig-Holstein, Kiel Campus Christian Albrechts University Kiel Kiel Germany.
Mov Disord Clin Pract. 2022 Jun 14;9(6):775-784. doi: 10.1002/mdc3.13490. eCollection 2022 Aug.
Despite over 30 years of clinical experience, high-quality studies on the efficacy of bilateral versus unilateral deep brain stimulation (DBS) of the ventral intermediate (VIM) nucleus of the thalamus for medically refractory essential tremor (ET) remain limited.
To compare benefits and risks of bilateral versus unilateral VIM DBS using the largest ET DBS clinical trial dataset available to date.
Participants from the US St. Jude/Abbott pivotal ET DBS trial who underwent staged-bilateral VIM implantation constituted the primary cohort in this sub-analysis. Their assessments "on" DBS at six months after second-side VIM DBS implantation were compared to the assessments six months after unilateral implantation. Two control cohorts of participants with unilateral implantation only were also used for between-group comparisons.
The primary cohort consisted of n = 38 ET patients (22M/16F; age of 65.3 ± 9.5 years). The second side VIM-DBS resulted in a 29.6% additional improvement in the total motor CRST score ( < 0.001), with a 64.1% CRST improvement in the contralateral side ( < 0.001). An added improvement was observed in the axial tremor score (21.4%, = 0.005), and CRST part B (24.8%, < 0.001) score. Rate of adverse events was slightly higher after bilateral stimulation.
In the largest ET DBS study to date, staged-bilateral VIM DBS was a highly effective treatment for ET with bilateral implantation resulting in greater reduction in total motor tremor scores when compared to unilateral stimulation alone.
尽管有30多年的临床经验，但关于丘脑腹中间核（VIM）双侧与单侧深部脑刺激（DBS）治疗药物难治性特发性震颤（ET）疗效的高质量研究仍然有限。
使用迄今为止可用的最大的ET DBS临床试验数据集，比较双侧与单侧VIM DBS的益处和风险。
美国圣犹达/雅培关键ET DBS试验中接受分期双侧VIM植入的参与者构成了本次亚分析的主要队列。将他们在第二侧VIM DBS植入后6个月的“开启”DBS评估与单侧植入后6个月的评估进行比较。两个仅进行单侧植入的参与者对照队列也用于组间比较。
主要队列包括n = 38例ET患者（22例男性/16例女性；年龄65.3±9.5岁）。第二侧VIM-DBS使总运动CRST评分额外提高了29.6%（P<0.001），对侧CRST改善了64.1%（P<0.001）。轴向震颤评分（21.4%，P = 0.005）和CRST B部分（24.8%，P<0.001）评分也有额外改善。双侧刺激后的不良事件发生率略高。
在迄今为止最大的ET DBS研究中，分期双侧VIM DBS是一种治疗ET的高效方法，与单独单侧刺激相比，双侧植入导致总运动震颤评分降低幅度更大。
