Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
研究概览
简要总结
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
- •UPDRS III score of >25 in the meds OFF condition
- •Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
排除标准
- •Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
- •Any current drug or alcohol abuse as determined by the investigator
- •Any history of recurrent or unprovoked seizures
- •Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months
研究组 & 干预措施
Ring mode followed by Unrestricted mode
omni-directional stimulation followed by unrestricted Mode stimulation
干预措施: BSC Deep Brain Stimulation System with Directional Lead (Device)
Unrestricted mode followed by ring mode
Unrestricted Mode stimulation followed by omni-directional stimulation
干预措施: BSC Deep Brain Stimulation System with Directional Lead (Device)
结局指标
主要结局
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
时间窗: Up to 12 months post-implant
Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
次要结局
未报告次要终点