目的

探讨丘脑底核变频刺激（variable frequency stimulation of the subthalamic nucleus, STN-VFS）在改善原发性帕金森病（Parkinson’s disease, PD）患者症状，尤其是运动功能方面的疗效，并探索其程控参数优化策略。

方法

采用单中心、随机、双盲、交叉对照设计，纳入18例既往接受双侧丘脑底核脑深部电刺激（deep brain stimulation of the subthalamic nucleus，STN-DBS)的帕金森病患者，进行变频刺激（variable frequency stimulation，VFS）与恒高频刺激（high frequency stimulation，HFS）条件下的运动功能评估。主要评价指标为计时起立行走测试（Time Up and Go Test，TUG）时间；次要评价指标包括TUG步态评分、TUG步数、运动障碍协会统一帕金森病评定量表（Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale, MDS-UPDRS）等。程控参数测试包括不同循环周期（60s、10s、1s）与低频占比（low frequency rate，LR）的组合。

结果

变频刺激在改善患者运动症状方面与恒频刺激相当，在部分患者中表现出更优疗效，尤其在药物开期条件下MDS-UPDRS III和中轴评分改善更明显（P<0.05）。41.67%的患者在变频条件下达到较恒频刺激更大的临床响应。与恒频刺激相较，变频刺激能显著降低总电荷能量灌注（total electrical energy delivered，TEED）（P=0.0024）。10秒循环周期的方案在疗效和主观感受上优于60秒或1秒周期，初始程控设置低频占比在10%–20%之间，长期使用变频后，患者低频占比的耐受性增强。

结论

STN-VFS在改善帕金森病运动症状，特别是步态障碍方面具有良好疗效，并能显著降低刺激能耗。通过优化循环周期与低频占比参数，VFS有望成为对HFS疗效不佳患者的有效补充治疗方式。未来应进一步扩大样本、延长随访、结合个体神经生理特征，推动该技术在临床中的标准化与个体化应用。

Objective

To evaluate the clinical efficacy of variable frequency stimulation of the subthalamic nucleus (STN-VFS) in improving symptoms—particularly motor function—in patients with primary Parkinson’s disease (PD), and to explore optimal programming strategies for variable frequency stimulation (VFS).

Methods

This single-center, randomized, double-blind, crossover trial enrolled 18 PD patients with prior bilateral deep brain stimulation of the subthalamic nucleus (STN-DBS) implantation and gait impairment. Patients were tested under both high frequency stimulation (HFS) and VFS settings. The primary outcome measure was the Timed Up and Go (TUG) test duration; secondary outcome measures included TUG gait scoring, TUG step count, the Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), etc. Programming parameters included varying cycle durations (60s, 10s, 1s) and low frequency rate (LR) to determine the individualized optimal configuration.

Results

VFS achieved comparable or superior motor improvements compared to HFS. In particular, under the medication ON condition, VFS significantly improved total MDS-UPDRS III and axial sub-scores (items 9–14) (P<0.05). Approximately 41.67% of participants demonstrated clinically meaningful improvement with VFS over HFS. TEED was significantly lower under VFS compared to HFS (P=0.0024). The 10-second cycle duration emerged as the most effective and better tolerated option compared to 60s or 1s cycles. Initial programming with a low-frequency ratio of 10%–20% was generally well tolerated, with a trend toward increased ratio tolerance during long-term use.

Conclusions

STN-VFS is a promising alternative or adjunct programming mode in PD, especially for patients with suboptimal response to conventional HFS. It can effectively improve gait disturbances and reduce energy consumption, enhancing the longevity and safety of DBS therapy. Optimization of key parameters such as cycle duration and low frequency rate is essential. Further large-scale and long-term studies are warranted to confirm efficacy, investigate underlying mechanisms, and promote individualized clinical application of VFS.