National Engineering laboratory for Neuromodulation, Tsinghua University, Beijing, China.
Department of Functional Neurosurgery, Beijing Tiantan Hospital, Beijing, China.
Trials. 2019 Dec 19;20(1):749. doi: 10.1186/s13063-019-3884-4.
Deep-brain stimulation targeting the subthalamic nucleus (STN) can be used to treat motor symptoms and dyskinesia in the advanced stages of Parkinson's disease (PD). High-frequency stimulation (HFS) of the STN can lead to consistent, long-term improvement of PD symptoms. However, the effects of HFS on the axial symptoms of PD, specifically freezing of gait, can be limited or cause further impairment. While this can be alleviated via relatively low-frequency stimulation (LFS) in selected patients, LFS does not control all motor symptoms of PD. Recently, the National Engineering Laboratory for Neuromodulation reported preliminary findings regarding an efficient way to combine the advantages of HFS and LFS to form variable-frequency stimulation (VFS). However, this novel therapeutic strategy has not been formally tested in a randomized trial.
METHODS/DESIGN: We propose a multicenter, double-blind clinical trial involving 11 study hospitals and an established deep-brain stimulation team. The participants will be divided into a VFS and a constant-frequency stimulation group. The primary outcome will be changes in stand-walk-sit task scores after 3 months of treatment in the "medication off" condition. Secondary outcome measures include specific item scores on the Freezing of Gait Questionnaire and quality of life. The aim of this trial is to investigate the efficacy and safety of VFS compared with constant-frequency stimulation.
This is the first randomized controlled trial to comprehensively evaluate the effectiveness and safety of VFS of the STN in patients with advanced PD. VFS may represent a new option for clinical treatment of PD in the future.
ClinicalTrials.gov, NCT03053726. Registered on February 15, 2017.
深部脑刺激靶向丘脑底核（STN）可用于治疗帕金森病（PD）晚期的运动症状和运动障碍。STN 的高频刺激（HFS）可导致 PD 症状的持续、长期改善。然而，HFS 对 PD 的轴性症状（特别是冻结步态）的影响可能有限或导致进一步的损害。虽然在选定的患者中可以通过相对较低频刺激（LFS）来缓解，但 LFS 并不能控制 PD 的所有运动症状。最近，国家神经调控工程实验室报告了一种有效结合 HFS 和 LFS 优势形成变频率刺激（VFS）的初步发现。然而，这种新的治疗策略尚未在随机试验中得到正式测试。
方法/设计：我们提出了一项多中心、双盲临床试验，涉及 11 家研究医院和一个已建立的深部脑刺激团队。参与者将分为 VFS 组和恒频刺激组。主要结局将是在“停药”状态下治疗 3 个月后站立-行走-坐下任务评分的变化。次要结局指标包括冻结步态问卷的特定项目评分和生活质量。本试验旨在研究 VFS 与恒频刺激相比的疗效和安全性。
这是第一项全面评估 VFS 对晚期 PD 患者 STN 疗效和安全性的随机对照试验。VFS 可能代表未来 PD 临床治疗的新选择。
ClinicalTrials.gov，NCT03053726。于 2017 年 2 月 15 日注册。
