Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson
研究概览
简要总结
The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.
PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.
Researchers will compare data collected from patients with DBS versus patients with best medical therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease patients candidates for DBS of the subthalamic nucleus
- •Parkinson's disease patients with best medical treatment
排除标准
- •patients unable to complete study assessments
结局指标
主要结局
Questionnaire for Impulsive-Compulsive Disorders in Parkinson
时间窗: Annual assessments up to 5 years
Impulsivity change from baseline to 5 years (QUIP, min 0, max 112, higher score means worse outcome)
Long-term characterization of DBS-STN on cognitive outcomes
时间窗: Annual assessments up to 5 years
Cognitive impairment change from baseline until 5 years in Montreal Cognitive Assessment (MoCA; min. 0, max. 30, higher score means better outcome) \[Time Frame: Annual assessments up to 5 years\]
Beck Depression Inventory
时间窗: Annual assessments up to 5 years
Depressive symptoms change from baseline to 5 year (BDI-II, min 0, max 63, higher score means worse outcome)
Parkinson's Disease Questionnaire-8
时间窗: Annual assessments up to 5 years
Quality of life change from baseline to 5 years (PDQ-8, min 0, max 100, higher score means worse outcome)
State-Trait Anxiety Inventory
时间窗: Annual assessments up to 5 years
Anxiety symptoms change from baseline to 5 year (STAI, min 20, max 80, higher score means worse outcome)
Minnesota Multiphasic Personality Inventory 2-RF
时间窗: Annual assessments up to 5 years
Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T\>65 for clinical scales)
Pittsburgh Sleep Quality Index
时间窗: Annual assessments up to 5 years
Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality)
次要结局
未报告次要终点