NCT04285099Unknown不适用
Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Stimulation frequency ratio in 4 weeks
研究概览
简要总结
We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS.
详细描述
The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. After four weeks, the investigators will check the UPDRS part I, II, IV, FOG-Q, and PDQ-39 values at each frequency, including the proportion of use of two frequencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Because our study is a double-blinded trial within one group, participant and investigator do not know whether the frequency is 130Hz or 60Hz.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with PD who are aged 30 years or older
- •patients with bilateral STN-DBS
- •patients who have a FOG at their med "off" state in outpatient clinic or hospitalization, or UPDRS part II FOG subscore above 1
排除标准
- •patients without FOG
- •patients who have undergone DBS
- •patients who have had previous brain surgery
- •patients who have undergone reoperation of DBS
- •patients who underwent unilateral DBS
- •patients with cognitive impairment (MMSE <18)
结局指标
主要结局
Stimulation frequency ratio in 4 weeks
时间窗: 4 weeks
Proportion of two frequencies in 4 weeks
次要结局
- Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week(4 weeks)
- Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week(4 weeks)
- Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week(4 weeks)
- Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week(4 weeks)
- Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week(4 weeks)
研究者
BS Jeon
Professor
Seoul National University Hospital
研究点 (1)
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