Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Local Field Potential Recordings using G106R
研究概览
简要总结
Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age ≥18，≤75，idiopathic Parkinson's disease，both male and female
- •MMSE score ≥24
- •H-Y score ≥2.0 on the medicine off situation
- •UPDRS-III score≥30 on the medicine off situation
- •The duration of this disease ≥5 years
- •Ability to provide informed consent as determined by preoperative neuropsychological assessment
- •History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients
- •Excellent responsiveness to levodopa
- •≥6h in medicine off state
排除标准
- •Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
- •Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
- •Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases
- •Patients who are unable to follow verbal instructions
- •Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
结局指标
主要结局
Local Field Potential Recordings using G106R
时间窗: 1 month,3 months, 6 months and 12months
UPDRS part III
时间窗: 1 month,3 months, 6 months and 12months
次要结局
- UPDRS part III(1, 3 months of stimulation)
- UPDRS part II(1, 3 months stimulation)
- Local Field Potential Recordings using G106R(1 month, 3 months)
- Levodopa Equivalent Dose(1, 3 months stimulation)