Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The change rate of MDS-UPDRS III
研究概览
简要总结
To compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.
详细描述
This is a randomized, parallel controlled, multi-center study to compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery. Participants will be followed for up to 12 months. Approximately 180 PD participants will be recruited from up to 14 sites. Participants will be randomized to current mode or voltage mode after DBS surgery and be comprehensively assessed at baseline and follow up according to the protocol developed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's disease
- •Aged 18 to 75, no limited sex
- •After bilateral STN-DBS, yet not powered on
排除标准
- •Mental disorders or dementia
- •Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy
- •Serious health conditions, such as tumors, liver or kidney diseases, etc.
- •Epilepsy or other seizure disorders
- •Patients with severely deviated electrode placement
- •Patients who were unable to voluntarily sign an informed consent form
- •Patients who did not agree to cooperate with follow-up
研究组 & 干预措施
Constant current (CC) subthalamic nucleus deep brain stimulation
干预措施: Constant current (CC) subthalamic nucleus deep brain stimulation (Other)
Constant voltage (CV) subthalamic nucleus deep brain stimulation
干预措施: Constant voltage (CV) subthalamic nucleus deep brain stimulation (Other)
结局指标
主要结局
The change rate of MDS-UPDRS III
时间窗: from baseline to 6 months after surgery
MDS-UPDRS III is the motor examination section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), completed by the evaluator, providing an objective assessment of motor symptoms in patients with Parkinson's disease. MDS-UPDRS III ranges from 0-132. The change rate of MDS-UPDRS III in the Stim-On/Med-On state from baseline to 6 months after surgery will be collected. Positive indicates improvement.
次要结局
- MDS-UPDRS I(from baseline to 6 months after surgery)
- MDS-UPDRS II(from baseline to 6 months after surgery)
- MDS-UPDRS IV(from baseline to 6 months after surgery)
- Clinical Global Impression (CGI)(from baseline to 6 months after surgery)
- Physician satisfaction feedback(from baseline to 6 months after surgery)
- Patient satisfaction feedback(from baseline to 6 months after surgery)
- power consumption(from baseline to 6 months after surgery)
- impecence(from baseline to 6 months after surgery)
- Adverse effects(from baseline to 12 months after surgery)