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标题：Variable- versus constant-frequency deep-brain stimulation in patients with advanced Parkinson’s disease: study protocol for a randomized controlled trial
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作者：Fumin Jia ; Jianguo Zhang ; Huimin Wang 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2019
卷号：20
期号：1
页码：749-755
DOI：10.1186/s13063-019-3884-4
出版社：BioMed Central
摘要：BACKGROUND :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. DISCUSSION :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. TRIAL REGISTRATION :ClinicalTrials.gov, NCT03053726. Registered on February 15, 2017.
关键词：Parkinson’s disease; Deep-brain stimulation; Variable frequency stimulation; Subthalamic nucleus