A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
研究概览
简要总结
Based on studies showing better responsiveness of motor versus cognitive symptoms to Parkinson's Disease medication, also known as dopaminergic treatments, the investigators hypothesize that comparison of resting state networks in the on versus off medication state in Parkinson's Disease patients will show greater effects on brain networks associated with motor control.
详细描述
Subject participation includes two 25-30 minute MRI scans. The subject will arrive in the "off" state (PD medications withheld for approximately 12 hours prior to the scan). Following the initial scan, the subject will receive 125% of his or her usual daily morning dose of PD medications which is calculated as levodopa dose equivalents (LDE) and is given as carbidopa-levodopa. The subject will then wait for an hour allowing for the medication to begin working. During this time the subject will complete cognitive assessments, questionnaires regarding the history and current state of PD, and motor assessments. The subject will then undergo a second MRI scan of approximately 25-30 minutes. The subject after completing the second MRI scan is free to leave. The entire study is approximately 2 and 1/2 hours long.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease (PD)
- •Older than 30 years of age at the time of diagnosis
- •Hoehn and Yahr stage greater than or equal to 2.5
- •PD duration greater than 3 years
- •Stable regimen of PD medications for at least 2 weeks prior to imaging
- •PD medications include carbidopa-levodopa
排除标准
- •Patients with a diagnosis of other neurodegenerative conditions
- •Patients unwilling or unable to give informed consent
- •Contraindications (cardiac pacemaker, etc.) or inability (e.g., claustrophobia) to undergo MRI scan
研究组 & 干预措施
On / Off medication
Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
干预措施: Carbidopa-Levodopa (Drug)
结局指标
主要结局
Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.
时间窗: 1 hour
Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.
次要结局
未报告次要终点
研究者
Darren Gitelman
Medical Doctor, Associate Professor of Neurology and Physiology
Northwestern University