VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 7
- 主要终点
- Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).
研究概览
简要总结
The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
详细描述
This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) to document patient outcomes, including effectiveness, safety, and health economic data for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
- •Duration of bilateral idiopathic PD of more than five years.
- •Stable medications
- •UPDRS subset III score of ≥30 without medication.
- •Lack of dementia or depression.
- •Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
- •Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
- •Is willing and able to comply with all visits and study related procedures
- •Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
排除标准
- •Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- •Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
- •Any significant psychiatric problems, including unrelated clinically significant depression.
- •Any current drug or alcohol abuse.
- •Any history of recurrent or unprovoked seizures.
- •Frequent falls while receiving good medication therapy without dyskinesias (on-state).
- •Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- •Any other active implanted device.
- •Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
- •A history of neurostimulation intolerance in any area of the body.
- •A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
- •Currently on any anticoagulant medications that can not be discontinued during perioperative period.
- •Have 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.
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- •A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
结局指标
主要结局
Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).
时间窗: 26 weeks post first lead implantation
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.
次要结局
- Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.(12 and 52 weeks post first lead implantation)
- Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation(12, 26 and 52 weeks post first lead implantation)
- Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.(12, 26 and 52 weeks post first lead implantation)
- Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.(12, 26 and 52 weeks post first lead implantation)
- Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.(12, 26 and 52 weeks post first lead implantation)
- Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on(12, 26 and 52 weeks post first lead implantation)
- Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.(52 weeks post first lead implantation)