Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Trials. 2024 Aug 16;25(1):543. doi: 10.1186/s13063-024-08385-2.
Repetitive transcranial magnetic stimulation (rTMS) is one of the non-invasive brain stimulations that modulate cortical excitability through magnetic pulses. However, the effects of rTMS on Parkinson's disease (PD) have yielded mixed results, influenced by factors including various rTMS stimulation parameters as well as the clinical characteristics of patients with PD. There is no clear evidence regarding which patients should be applied with which parameters of rTMS. The study aims to investigate the efficacy and safety of personalized rTMS in patients with PD, focusing on individual functional reserves to improve ambulatory function.
This is a prospective, exploratory, multi-center, single-blind, parallel-group, randomized controlled trial. Sixty patients with PD will be recruited for this study. This study comprises two sub-studies, each structured as a two-arm trial. Participants are classified into sub-studies based on their functional reserves for ambulatory function, into either the motor or cognitive priority group. The Timed-Up and Go (TUG) test is employed under both single and cognitive dual-task conditions (serial 3 subtraction). The motor dual-task effect, using stride length, and the cognitive dual-task effect, using the correct response rate of subtraction, are calculated. In the motor priority group, high-frequency rTMS targets the primary motor cortex of the lower limb, whereas the cognitive priority group receives rTMS over the left dorsolateral prefrontal cortex. The active comparator for each sub-study is bilateral rTMS of the primary motor cortex of the upper limb. Over 4 weeks, the participants will undergo 10 rTMS sessions, with evaluations conducted pre-intervention, mid-intervention, immediately post-intervention, and at 2-month follow-up. The primary outcome is a change in TUG time between the pre- and immediate post-intervention evaluations. The secondary outcome variables are the TUG under cognitive dual-task conditions, Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III, New Freezing of Gait Questionnaire, Digit Span, trail-making test, transcranial magnetic stimulation-induced motor-evoked potentials, diffusion tensor imaging, and resting state functional magnetic resonance imaging.
The study will reveal the effect of personalized rTMS based on functional reserve compared to the conventional rTMS approach in PD. Furthermore, the findings of this study may provide empirical evidence for an rTMS protocol tailored to individual functional reserves to enhance ambulatory function in patients with PD.
ClinicalTrials.gov NCT06350617. Registered on 5 April 2024.
重复经颅磁刺激（rTMS）是一种非侵入性脑刺激方法，通过磁场脉冲调节皮质兴奋性。然而，rTMS 对帕金森病（PD）的影响产生了混杂的结果，受多种 rTMS 刺激参数以及 PD 患者的临床特征等因素影响。对于应该应用哪种 rTMS 参数，尚无明确证据。本研究旨在探讨个性化 rTMS 在 PD 患者中的疗效和安全性，重点关注个体功能储备以改善步行功能。
这是一项前瞻性、探索性、多中心、单盲、平行组、随机对照试验。将招募 60 名 PD 患者参加本研究。本研究包括两个亚研究，每个亚研究均采用两臂试验设计。根据步行功能的功能储备，将参与者分为运动或认知优先组。在单任务和认知双重任务条件下（连续 3 次减法）进行计时起立行走（TUG）测试。计算运动双重任务效应，采用步长；计算认知双重任务效应，采用减法正确反应率。在运动优先组中，高频 rTMS 作用于下肢初级运动皮层；而认知优先组则接受左侧背外侧前额叶皮层 rTMS。每个亚研究的主动对照为上肢初级运动皮层双侧 rTMS。在 4 周内，参与者将接受 10 次 rTMS 治疗，在干预前、干预中期、干预即刻和 2 个月随访时进行评估。主要结局是干预前和干预即刻评估之间 TUG 时间的变化。次要结局变量包括认知双重任务下的 TUG、运动障碍协会统一帕金森病评定量表第 III 部分、新冻结步态问卷、数字跨度、连线测试、经颅磁刺激诱发运动诱发电位、弥散张量成像和静息态功能磁共振成像。
本研究将揭示基于功能储备的个性化 rTMS 与常规 rTMS 方法在 PD 中的效果差异。此外，本研究的结果可能为基于个体功能储备的 rTMS 方案提供经验证据，以增强 PD 患者的步行功能。
ClinicalTrials.gov NCT06350617。于 2024 年 4 月 5 日注册。
