A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Safety: Adverse Events
研究概览
简要总结
The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features
详细描述
The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female age 30 years or older
- •Able and willing to give consent and able to attend all study visits
- •A confirmed diagnosis of Parkinsons Disease
- •Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
- •Able to localize subthalamic nucleus on MRI for treatment
- •Able to communicate sensations during the ExAblate MRgFUS procedure
排除标准
- •Hoehn and Yahr stage in the ON medication state of 2.5 or greater
- •Presence of severe dyskinesia as noted by MDS-UPDRS scores
- •Presence of other central neurodegenerative disease
- •Parkinsonian symptoms are a side effect from neuroleptic medications
- •Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- •History of a bleeding disorder or receiving anticoagulant
- •Subjects with advanced kidney disease or on dialysis
- •Subjects with known intolerance or allergies to the MRI contrast agents.
- •Presence of unknown or MRI unsafe devices anywhere in the body.
- •History of multiple strokes, or a stroke within past 6 months
- •Subjects with a history of seizures within the past year
- •Subjects with malignant brain tumors
- •Women who are pregnant or nursing
结局指标
主要结局
Safety: Adverse Events
时间窗: Treatment through 6 month
To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.
Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status
时间窗: Treatment through 6 month
Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (reduction from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition
次要结局
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status(Treatment through 6 month)
- MDS-UPDRS(Treatment through 12 month)
- MDS-UPDRS (Part I, II and IV)(Treatment through 6 month)
- Quality of life assessment(Treatment through 6 month)
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status(Treatment through 6 month)
- MDS-UPDRS(Treatment through 12 month)
- MDS-UPDRS (Part I, II and IV)(Treatment through 6 month)
- Quality of life assessment(Treatment through 6 month)