University of Florida, Department of Neurology, Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA; Department of Neurology, Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, PA, USA.
University of Florida, Department of Neurology, Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Parkinsonism Relat Disord. 2018 Jan;46:41-46. doi: 10.1016/j.parkreldis.2017.10.015. Epub 2017 Oct 20.
Conventional deep brain stimulation (DBS) utilizes regular, high frequency pulses to treat medication-refractory symptoms in essential tremor (ET). Modifications of DBS pulse shape to achieve improved effectiveness is a promising approach.
The current study assessed the safety, tolerability and effectiveness of square biphasic pulse shaping as an alternative to conventional ET DBS.
This pilot study compared biphasic pulses (BiP) versus conventional DBS pulses (ClinDBS). Eleven ET subjects with clinically optimized ventralis intermedius nucleus DBS were enrolled. Objective measures were obtained over 3 h while ON BiP stimulation.
There was observed benefit in the Fahn-Tolosa Tremor Rating Scale (TRS) for BiP conditions when compared to the DBS off condition and to ClinDBS setting. Total TRS scores during the DBS OFF condition (28.5 IQR = 24.5-35.25) were significantly higher than the other time points. Following active DBS, TRS improved to (20 IQR = 13.8-24.3) at ClinDBS setting and to (16.5 IQR = 12-20.75) at the 3 h period ON BiP stimulation (p = 0.001). Accelerometer recordings revealed improvement in tremor at rest (χ = 16.1, p = 0.006), posture (χ = 15.9, p = 0.007) and with action (χ = 32.1, p=<0.001) when comparing median total scores at ClinDBS and OFF DBS conditions to 3 h ON BiP stimulation. There were no adverse effects and gait was not impacted.
BiP was safe, tolerable and effective on the tremor symptoms when tested up to 3 h. This study demonstrated the feasibility of applying a novel DBS waveform in the clinic setting. Larger prospective studies with longer clinical follow-up will be required.
传统的深部脑刺激（DBS）利用常规的高频脉冲来治疗原发性震颤（ET）药物难治性症状。改变 DBS 脉冲形状以提高疗效是一种很有前途的方法。
本研究评估了作为传统 ET DBS 替代方法的双相方波脉冲成形的安全性、耐受性和有效性。
这项初步研究比较了双相脉冲（BiP）与传统 DBS 脉冲（ClinDBS）。11 名接受了临床优化腹侧中间核 DBS 的 ET 患者参与了这项研究。在 ON BiP 刺激期间，进行了 3 小时的客观测量。
与 DBS 关闭状态和 ClinDBS 设置相比，BiP 条件下的 Fahn-Tolosa 震颤评定量表（TRS）观察到获益。在 DBS 关闭状态下（28.5 IQR=24.5-35.25）的总 TRS 评分明显高于其他时间点。在使用活性 DBS 后，TRS 在 ClinDBS 设置下改善至（20 IQR=13.8-24.3），在 3 小时的 BiP 刺激 ON 期改善至（16.5 IQR=12-20.75）（p=0.001）。加速度计记录显示，在比较 ClinDBS 和 OFF DBS 条件下的中位总评分与 3 小时 ON BiP 刺激时，休息时（χ=16.1，p=0.006）、姿势时（χ=15.9，p=0.007）和运动时（χ=32.1，p<0.001）的震颤得到改善。没有不良反应，步态也没有受到影响。
BiP 在测试至 3 小时时对震颤症状是安全、耐受和有效的。这项研究证明了在临床环境中应用新型 DBS 波形的可行性。需要更大规模的前瞻性研究，进行更长时间的临床随访。
