齿状核红核丘脑束刺激治疗原发性震颤的深部脑刺激：一项盲法临床试验。
Directed stimulation of the dentato-rubro-thalamic tract for deep brain stimulation in essential tremor: a blinded clinical trial.
机构信息
Department of Radiology, Mayo Clinic, USA.
Department of Neurosurgery, Mayo Clinic, USA.
出版信息
Neuroradiol J. 2022 Apr;35(2):203-212. doi: 10.1177/19714009211036689. Epub 2021 Aug 2.
OBJECTIVE
Observational studies utilising diffusion tractography have suggested a common mechanism for tremor alleviation in deep brain stimulation for essential tremor: the decussating portion of the dentato-rubro-thalamic tract. We hypothesised that directional stimulation of the dentato-rubro-thalamic tract would result in greater tremor improvement compared to sham programming, as well as comparable improvement as more tedious standard-of-care programming.
METHODS
A prospective, blinded crossover trial was performed to assess the feasibility, safety and outcomes of programming based solely on dentato-rubro-thalamic tract anatomy. Using magnetic resonance imaging diffusion-tractography, the dentato-rubro-thalamic tract was identified and a connectivity-based treatment setting was derived by modelling a volume of tissue activated using directional current steering oriented towards the dentato-rubro-thalamic tract centre. A sham setting was created at approximately 180° opposite the connectivity-based treatment. Standard-of-care programming at 3 months was compared to connectivity-based treatment and sham settings that were blinded to the programmer. The primary outcome measure was percentage improvement in the Fahn-Tolosa-Marín tremor rating score compared to the preoperative baseline.
RESULTS
Among the six patients, tremor rating scores differed significantly among the three experimental conditions (=0.030). The mean tremor rating score improvement was greater with the connectivity-based treatment settings (64.6% ± 14.3%) than with sham (44.8% ± 18.6%; =0.031) and standard-of-care programming (50.7% ± 19.2%; =0.062). The distance between the centre of the dentato-rubro-thalamic tract and the volume of tissue activated inversely correlated with the percentage improvement in the tremor rating score (R=0.24; =0.04). No significant adverse events were encountered.
CONCLUSIONS
Using a blinded, crossover trial design, we have shown the technical feasibility, safety and potential efficacy of connectivity-based stimulation settings in deep brain stimulation for treatment of essential tremor.
目的
利用弥散张量成像技术的观察性研究表明，深部脑刺激治疗原发性震颤的震颤缓解的共同机制是齿状核红核丘脑束的交叉部分。我们假设，与假刺激编程相比，定向刺激齿状核红核丘脑束将导致更大的震颤改善，并且与更繁琐的标准护理编程相比，也会有可比的改善。
方法
进行了一项前瞻性、盲法交叉试验，以评估仅基于齿状核红核丘脑束解剖结构进行编程的可行性、安全性和结果。使用磁共振成像弥散张量成像，识别齿状核红核丘脑束，并通过对定向电流导向激活的组织体积进行建模，得出基于连接的治疗设置，该设置的方向朝向齿状核红核丘脑束的中心。在大约 180°相对基于连接的治疗的位置创建了一个假设置。将 3 个月时的标准护理编程与编程者盲法的基于连接的治疗和假设置进行比较。主要的结果测量是与术前基线相比，Fahn-Tolosa-Marín 震颤评分的改善百分比。
结果
在 6 名患者中，三种实验条件之间的震颤评分差异显著（=0.030）。基于连接的治疗设置的震颤评分改善平均值（64.6%±14.3%）大于假刺激（44.8%±18.6%；=0.031）和标准护理编程（50.7%±19.2%；=0.062）。齿状核红核丘脑束中心与激活组织体积之间的距离与震颤评分改善的百分比呈负相关（R=0.24；=0.04）。未发生明显不良事件。
结论
使用盲法、交叉试验设计，我们已经证明了基于连接的刺激设置在深部脑刺激治疗原发性震颤中的技术可行性、安全性和潜在疗效。
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