The Effect of Repetitive Transcranial Magnetic Stimulation Over the Supplementary Motor Area on Gait Performance in Parkinson's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in duration of anticipatory postural adjustments (APAs) during gait initiation
研究概览
简要总结
This study aims to investigate the effects of high-frequency and low-frequency repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) on gait performance, especially gait initiation, in individuals with Parkinson's disease (PD). Furthermore, the investigators will explore the impact of rTMS over the SMA on walking speed, functional mobility, and limits of stability in PD. It is hypothesized that rTMS over the SMA will improve gait performance in PD.
详细描述
The goal of this clinical trial is to investigate the effects of high-frequency and low-frequency rTMS over the SMA on gait performance, especially gait initiation, in individuals with PD. The primary outcome will be anticipatory postural adjustments (APAs) during gait initiation. The secondary outcome will include walking speed, the timed up-and-go test (TUG), and limits of stability.
The hypotheses are:
- Both 25 Hz and 1 Hz rTMS will have a significant effect on gait performance, especially the gait initiation phase, as assessed by APAs in PD, compared with sham stimulation.
- 25 Hz and 1 Hz rTMS will have a different effect on gait initiation in PD.
This study will be a three-arm, randomized, double-blind, placebo-controlled study examining the effect of 25 Hz or 1 Hz SMA-TMS compared with that observed after sham TMS. A total of 81 individuals with PD will be recruited and allocated into three different groups: 1 Hz TMS group, 25 Hz TMS group, and sham TMS group. Participants in each group will receive 10 TMS sessions over 2 weeks. Assessors will conduct evaluations at baseline, post-intervention, and 4-week post-intervention. The primary outcome will be APAs during gait initiation. The secondary outcome will include walking speed, TUG , and limits of stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with PD according to thecriteria set by Movement Disorder Committee,
- •with Hoehn and Yahr stages II-III, which are recognized as representing mild to moderate disease severity,
- •have self-reported difficulty in gait initiation, assessed by item 5 of the freezing of gait questionnaire (FOGQ),
- •have used a dopaminergic medication dose in the last month,
- •a minimum score of 23 of 30 points on the Montreal Cognitive Assessment (MoCA).
排除标准
- •patients with unstable medical conditions,
- •unable to provide informed consent,
- •other neurological conditions including stroke,
- •contraindications for TMS,
- •experienced deep brain stimulation treatment,
- •no recordable motor evoked potentials (MEPs) with TMS.
研究组 & 干预措施
25 Hz repetitive transcranial magnetic stimulation group
High-frequency repetitive transcranial magnetic stimulation (25 Hz), intended to increase cortical excitability and provide facilitatory neuromodulation.
干预措施: Transcranial Magnetic Stimulation (Device)
1 Hz repetitive transcranial magnetic stimulation group
Low-frequency repetitive transcranial magnetic stimulation (1 Hz), intended to decrease cortical excitability and provide inhibitory neuromodulation.
干预措施: Transcranial Magnetic Stimulation (Device)
Sham stimulation group
The stimulation coil is positioned identically to active TMS and emits similar auditory and scalp sensations, but delivers no significant magnetic pulse to the brain, mimicking the active intervention experience without neuromodulatory effects.
干预措施: Transcranial Magnetic Stimulation Sham (Device)
结局指标
主要结局
Change in duration of anticipatory postural adjustments (APAs) during gait initiation
时间窗: Baseline, 2 weeks (post-intervention)
The duration of APAs will be calculated from the center of pressure displacement trajectory, recorded by a force plate and Vicon motion capture system.
次要结局
- Change in duration of anticipatory postural adjustments (APAs) during gait initiation(Baseline and 6 weeks (4-week post-intervention))
- Change in comfortable walking speed of the 10-meter walk test(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in fast walking speed of the 10-meter walk test(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Changes in Timed Up-and-Go Test (TUG)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in Unified Parkinson's Disease Rating Scale-motor examination (UPDRS-III)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in score of Mini-Balance Evaluation System Test (MiniBEST)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in freezing of gait questionnaire (FOGQ)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in the 39-item Parkinson's disease questionnaire (PDQ-39)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in resting motor threshold (RMT)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Changes in the slope of the stimulus response curve (SRC)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in duration of anticipatory postural adjustments (APAs) during gait initiation(Baseline and 6 weeks (4-week post-intervention))
- Changes in Timed Up-and-Go Test (TUG)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in comfortable walking speed of the 10-meter walk test(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in fast walking speed of the 10-meter walk test(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in Unified Parkinson's Disease Rating Scale-motor examination (UPDRS-III)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in score of Mini-Balance Evaluation System Test (MiniBEST)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in freezing of gait questionnaire (FOGQ)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Changes in the slope of the stimulus response curve (SRC)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in the 39-item Parkinson's disease questionnaire (PDQ-39)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in resting motor threshold (RMT)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Change in short-interval intracortical inhibition (SICI)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))
- Intracortical facilitation (ICF)(Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention))