Longitudinal Outcomes of Deep Brain Stimulation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease Rating Scale, Part III (UPDRS III)
研究概览
简要总结
Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Pre-operatively, each patient is extensively evaluated with a battery of validated motor, cognitive, and mood instruments. This information is stored in RedCAP, a secure online database platform. In an attempt to capture longitudinal outcomes in this population of interest, we will recruit all PD patients two years or more status post DBS who are receiving regular care at Vanderbilt University Medical Center. Study participants will undergo a condensed evaluation of motor function (Unified Parkinson's Disease Rating Scale Part III), cognitive performance (Mini-Mental Status Examination), mood (Beck Depression Inventory), and quality of life (Parkinson's Disease Questionnaire-39). These results will be compared to baseline measures performed pre-operatively, allowing for assessment of interval change. STN and GPi DBS patients will be analyzed separately.
详细描述
Patients will be recruited from review of movement disorders neurologists' outpatient census. All patients with PD two or more years status post DBS will be contacted via phone and/or mailed letter. Any interested patient will be mailed or e-mailed (via RedCAP) a copy of the study informed consent form. Willing patients will present to the Vanderbilt Movement Disorders Clinic for an opportunity to inquire further about the study and sign the informed consent form in person.
Participants will have a single study visit, ideally coordinated with their regularly scheduled neurology follow-up. During the study visit, the following evaluations will be performed by a trained research assistant:
Video-recorded UPDRS III BDI MMSE PDQ-39 In addition, current PD medications and number of falls in the past 6 months will be recorded. Assessments will occur in the on-medication, on-DBS state.
The video-recorded UPDRS III will be reviewed and score at a subsequent date by a blinded rater (movement discord trained neurologist).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Parkinson's disease
- •status post deep brain stimulation (DBS) implantation in the subthalamic nucleus (STN) or globus pallidus interna (GPi) at Vanderbilt University Medical Center
排除标准
- •unable to complete study assessments
结局指标
主要结局
Unified Parkinson's Disease Rating Scale, Part III (UPDRS III)
时间窗: at least 2 years
Parkinson's disease motor assessment
次要结局
未报告次要终点
研究者
David Isaacs
Assistant Professor of Neurology
Vanderbilt University Medical Center