A Pilot Study to Investigating Safety of A Remote and Wireless Deep Brain Stimulation Programming System for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Deep Brain Stimulation Programming parameter
研究概览
简要总结
Remote programming has significant advantages over conventional programming methods on some issues. This research will test the safety of SceneRay remote and wireless DBS programming system.
详细描述
Programming is a crucial aspect of deep brain stimulation (DBS), directly influences the final success of DBS. Optimal programming helps patients achieve maximized control of clinical symptoms and higher life quality. However, there are a number of inadequacies in conventional programming methods. First, the programming probe must come into close contact with the implantable pulse generator (IPG) and test stimulator to complete programming. And during initial postoperative programming, only the parameters of one patient can be ascertained. In addition, the same frequency is typically used in the left and right brain for dual channel IPG. The patient also need to repeatedly travel between their home and the hospital, leading to increased time and expense. Therefore, the investigators developed the SceneRay wireless and remote DBS system to address the outline issues. This system has significant advantages over conventional programming methods on all the issues above. This research will test the safety of this remote and wireless DBS programming system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Primary PD patients volunteered to receive DBS surgery with SceneRay wireless and remote DBS system,
- •Age 18-75 years,
- •Achieved optimal control of clinical symptoms after coventional programming for 3-12 months,
- •Significant difference in motor function when DBS is switched on/off,
- •Good compliance and easy to follow-up,
排除标准
- •No significant improvement or clinical efficacy in symptoms after surgery,
- •Severe cognitive impairment due to dementia (Mini-Mental State Examination score: illiteracy <17, elementary school <20, junior high school or above <24) or inability to accurately record in a diary,
- •Active psychosis or a history of psychosis,
- •Serious heart, liver, or kidney diseases,
- •Severe hypertension or orthostatic hypotension, severe diabetes, or diabetes accompanied by brain and cardiovascular diseases,
- •Malignant cancer, brain injuries, epilepsy, or other unstable medical conditions,
- •Severe alcohol dependence or drug abuse,
- •Any situation that may jeopardize the patient's safety or lead to a failure to participate in the study (medical, psychological, social, or georational factors) at present or in the future,
- •Participating in other clinical trials,
- •Other factors that researchers think may not be suitable for research.
研究组 & 干预措施
remote programming system
干预措施: SceneRay wireless and remote DBS system (Device)
结局指标
主要结局
Deep Brain Stimulation Programming parameter
时间窗: Through study completion, an average of 4 months
Contact selection
Serious Adverse Event
时间窗: Through study completion, an average of 4 months
The Unified Parkinson's Disease Rating Scale III&IV
时间窗: Through study completion, an average of 4 months
次要结局
未报告次要终点
研究者
Bomin Sun
Director of functional neurosurgery department
Ruijin Hospital