NCT06494956尚未招募不适用
A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease
Jiangsu CED Medtech Co., Ltd0 个研究点目标入组 3 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
- 主要终点
- Drug dosage evaluation
研究概览
简要总结
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease
详细描述
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years old, patients with primary Parkinson's disease;
- •The duration of Parkinson's disease is 5 years or more;
- •The stage of Hoehn-Yahr in the "off" (without medication) state is 2 or more stages;
- •UPDRS motion score ≥30 in "Off" state;
- •Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg);
- •The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, and repeated adjustments of drugs still cannot be effectively improved;
- •MMSE score ≥24 points on the simple intelligent mental state Examination Scale;
- •Have the ability of independent external charging operation;
- •Patients or their family members can fully understand the treatment and sign informed consent;
- •The patient had good compliance and was able to meet the requirements of postoperative follow-up.
排除标准
- •Have received surgical treatment for Parkinson's disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.;
- •The "off" state has serious language disorders, dysphagia, balance disorders and other midline symptoms;
- •There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;
- •Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;
- •Patients who are abnormally sensitive to temperature or allergic to heat;
- •There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).
- •Patients with anxiety and depression.
结局指标
主要结局
Drug dosage evaluation
时间窗: 7 months
Subjects fill in diary cards
Subjects fill in a diary card after device implantation
时间窗: 6 months
Subjects fill in diary cards
Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary
时间窗: 7 months
Subjects fill in diary cards
Charging performance evaluation
时间窗: 6 months
Subjects fill in diary cards
次要结局
未报告次要终点
研究者
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