Abstract
BackgroundDeep-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/designWe 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03053726. Registered on February 15, 2017.
Highlights
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)
Our pilot study suggested that variable-frequency stimulation (VFS) composed of both High-frequency stimulation (HFS) and low-frequency stimulation (LFS) was safe, and we did not observe any clinically relevant neuropsychiatric adverse effects
New conceptions of Deep-brain stimulation (DBS) have focused on the use of LFS or combined STN/substantia nigra pars reticulata DBS for the treatment of axial symptoms in patients with PD [6, 9, 10]
Summary
Axial and appendicular motor symptoms severely affect the quality of life of patients with PD. The development of novel approaches to manage both axial and appendicular motor symptoms in patients with PD is critical. Based on these findings and our previously published case report [8], we hypothesize that patients with PD and FOG might benefit from STN-VFS. This multicenter, doubleblind, randomized clinical trial will enable us to evaluate the effect of a novel STN-VFS stimulation pattern on both axial and segmental symptoms of PD. This study was designed to evaluate the short-term effects and potential side-effects of VFS and CFS on axial symptoms in advanced PD. The trial will be ongoing from August 2017 to December 2019
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