Coordinated Reset Deep Brain Stimulation (RESET-DBS) and RESET-DBS - Extension (Sub-study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Improvement in Quality of Life using new programming paradigm: PDQ-39
研究概览
简要总结
The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
详细描述
The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
During follow-up, the conventional Deep Brain Stimulation (cDBS) program and one or more of these novel Deep Brain Stimulation (nDBS) programs are programmed into a subject's IPG. At the investigator's discretion, a copy of the cDBS program may also be stored in one of the investigational slots. The subject will be blinded to the slot number assignment for the cDBS program.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
- •Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
- •Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.
排除标准
- •Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
- •A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
结局指标
主要结局
Improvement in Quality of Life using new programming paradigm: PDQ-39
时间窗: approximately 4 weeks
Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores
次要结局
未报告次要终点