Predictors of Motor Progression in Parkinson's Disease
2019年6月4日 更新者:University of Minnesota
Predictors of Progression to Freezing of Gait in Parkinson's Disease
Treatment resistant motor features, such as postural instability and freezing of gait are common in people with Parkinson's disease and major contributors to morbidity and mortality.
This project will use sleep studies, quantitative motor assessments and magnetic resonance imaging to examine the relationship between abnormally increased muscle activity during rapid eye movement sleep and the development and progression of treatment-resistant postural instability and gait disturbances.
Specifically, the investigators will test the hypothesis that anticipatory postural adjustments (weight and pressure shifts) during gait initiation are significantly reduced in people with Parkinson's disease who have abnormally elevated muscle activity during rapid eye movement (REM) sleep compared to individuals will Parkinson's disease whose REM sleep muscle activity is normal.
In addition, the investigators will test the hypothesis that the level of RSWA at baseline is predictive of measures of motor decline (postural stability and gait) and alterations in the structure and function of locomotor brainstem networks.
Since sleep disorders can emerge years before a diagnosis of Parkinson's disease, establishment of a link between sleep and treatment-resistant posture and gait disorders will help identify individuals at risk of developing these disabling motor features of disease.
研究概览
研究类型
观察性的
注册 (实际的)
72
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Parkinson's Disease
描述
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's Disease (PD).
- Age 21-75 years
- Able to ambulate independently without the use of an assistive device (e.g. cane)
Exclusion Criteria:
- History of Dementia
- History of musculoskeletal disorders that adversely affects walking and/or balance
- Other significant neurological disorders
- Implanted deep brain stimulator(s) (DBS) or other neurosurgeries to treat PD
- MRI exclusion for 7 tesla scans: presence of any metallic clips or implantable medical devices
- Pregnant women
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Parkinson's Disease participants
People with early Parkinson's disease with mild-to-moderate severity of disease.
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Participants will be asked to visit the University for 3 baseline visits which include a screening visit & sleep study, movement tests and magnetic resonance imaging (MRI) scans.
Three years later the participant will be asked to repeat the same visits.
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Control participants
Volunteers who are age (+/- 3 years) and sex matched to the participants with Parkinson's disease
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Participants will be asked to visit the University for 3 baseline visits which include a screening visit & sleep study, movement tests and magnetic resonance imaging (MRI) scans.
Three years later the participant will be asked to repeat the same visits.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Magnitude of the center of pressure shift during gait initiation.
大体时间:Measured at baseline (time 0).
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The magnitude of the center of pressure shift during gait initiation is calculated as the displacement of the center of pressure signal from quiet standing (baseline) to the peak lateral and posterior excursion during the anticipatory postural adjustment phase of gait initiation.
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Measured at baseline (time 0).
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Correlation between measures of REM sleep without atonia (RSWA) at baseline and change in the magnitude of the center of pressure shift during gait initiation over the course of 3 years.
大体时间:Change in magnitude over the course of 3 years
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A linear correlation analysis will be conducted between measures of RSWA at baseline versus the change in shift of the center of pressure during gait initiation between baseline and year 3.
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Change in magnitude over the course of 3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年10月1日
初级完成 (实际的)
2019年5月31日
研究完成 (实际的)
2019年5月31日
研究注册日期
首次提交
2016年4月27日
首先提交符合 QC 标准的
2016年5月9日
首次发布 (估计)
2016年5月11日
研究记录更新
最后更新发布 (实际的)
2019年6月5日
上次提交的符合 QC 标准的更新
2019年6月4日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.