Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Effectiveness of DBS for Neuropsychiatric Fluctuations
研究概览
简要总结
Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)
详细描述
Pre-operative versus 12-Month Follow-Up analysis of changing in Neuropsychiatric Fluctuations Scale (NFS) score in preoperative versus postoperative MED OFF (during acute withdrawal of dopaminergic therapy) and MED ON (during super-liminal Levodopa dose) conditions. Postoperative evaluations are always performed with DBS turned on and stimulating (STIM ON)
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
- •Parkinson's disease
- •Treatment with Bilateral STN DBS
- •Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context
排除标准
- •DBS for non PD patients
- •Unilateral DBS or other DBS targets
- •Patients not evaluated with NFS
- •Patients with incomplete preoperative evaluation
- •Patients who refused the use of their data
结局指标
主要结局
Effectiveness of DBS for Neuropsychiatric Fluctuations
时间窗: 12 months after surgery
Improvement of Neuropsychiatric Fluctuation Scale (NFS) Score between preoperative MED ON and MED OFF conditions versus postoperative MED ON-STIM ON and MED OFF-STIM ON conditions. NFS ON and OFF med scores are independent and they ranges from -30 to +30. Positive scores represent good outcomes (good feelings, non OFF neuropsychiatric symptoms), whereas negative scores denote the presence of negative feelings in a quantity exceeding the positive ones
次要结局
- Neuropsychiatric Fluctuations and other Nonmotor Symptoms(12 months)
- Neuropsychiatric Fluctuations and Dopaminergic Therapy(12 Months)
- Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations(12 months)
- Neuropsychiatric Fluctuations, Cognitive and Psychiatric state(12 months)
- Neuropsychiatric Fluctuations, preoperative and postoperative motor status(12 months)