Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 106
- 主要终点
- Changs in the score of Stand-Walk-Sit Test
研究概览
简要总结
Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore >1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of age,male or female patients
- •idiopathic Parkinson's disease
- •had deep brain stimulaton implant
- •H-Y>2.0 in the absence of L-dopa
- •UPDRSII-14 item ≥1
- •UPDRSII-15 item ≥2
- •an ability to walk at least 10 meters independently
排除标准
- •Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- •Pregnant female
- •History of severe neuropsychiatric disease
- •Patients are taking part in other clinical trials in recent several months
研究组 & 干预措施
Patients with Various Frequency Stimulation
Patients are in the condition of Various Frequency Stimulation
干预措施: Beijing PINS Programming (Device)
Patients With Traditional Frequency Stimulation
Patients in the condition of Sham Comparator are Traditional Frequency Stimulation
干预措施: Beijing PINS Programming (Device)
结局指标
主要结局
Changs in the score of Stand-Walk-Sit Test
时间窗: 1、3、6 and 12 month
次要结局
- Change of the score in PDQ-39(1、3、6、12 months of Various Frequency Stimulation)
- Change of the score in the FOG-Q(1、3、6、12 month of Various Frequency Stimulation)
- Change of the score in UPDRS(1,3,6,12 months of Various Frequency Stimulation)