Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Change of Freezing of Gait Questionnaire (FOG-Q)
研究概览
简要总结
The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).
详细描述
Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as Parkinson's disease (PD) with freezing of gait
- •walk independently without walking devices
排除标准
- •pre-existing and active major neurological diseases other than PD
- •a previous history of seizures
- •implanted metallic objects that would contraindicate rTMS
研究组 & 干预措施
dual-mode group
the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
干预措施: rTMS and tDCS (Device)
rTMS group
high-frequency rTMS and sham tDCS
干预措施: rTMS (Device)
结局指标
主要结局
Change of Freezing of Gait Questionnaire (FOG-Q)
时间窗: Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5
Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.
次要结局
未报告次要终点
研究者
Yun-Hee Kim
Professor
Samsung Medical Center