A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Total Electrical Energy Delivered (TEED) to the patient
研究概览
简要总结
This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD.
The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.
详细描述
PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment.
Randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD;
- •DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%;
- •Patients must be able to sign the informed consent document to participate in the clinical trial;
- •Patients with a suboptimal response to DBS treatment.
排除标准
- •Patients with severe cognitive decline (MMSE <25);
- •Patients with major psychiatric issues;
- •Patients with any medical condition potentially interfering with DBS battery replacement surgery;
- •Patients that cannot tolerate an interruption of DBS stimulation;
- •Patients taking only one levodopa dose per day;
- •Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
- •Pregnant or breastfeeding women.
结局指标
主要结局
Total Electrical Energy Delivered (TEED) to the patient
时间窗: One day.
Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) part III(One day.)
- Incidence of device related Adverse Events (safety and tolerability)(One day.)
- Unified Dyskinesia Rating Scale (UDysRS)(One day.)