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临床试验/NCT01798563
NCT01798563已完成不适用

Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).

研究概览

简要总结

In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.

The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English as their primary language
  • Patients with Parkinson disease and healthy controls will be enrolled
  • Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month

排除标准

  • If unable to provide informed consent
  • Pregnancy
  • Excess of 300lbs
  • Claustrophobia
  • Metal in body
  • Untreated neurological or psychiatric condition, who are delusional or have hallucinations, with cognitive impairment (MOCA<26), with a history of head injury sufficient to cause a concussion, or with significant systemic medical diseases (e.g. heart failure, liver failure, kidney failure, poorly controlled diabetes, etc.)
  • Healthy control subjects will be excluded if taking any type of dopaminergic or anti-dopaminergic medication
  • Subjects who are unable to demonstrate understanding of the study procedures and risks will be excluded

结局指标

主要结局

Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).

时间窗: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.

Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.

Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.

时间窗: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).

A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.

次要结局

  • Connectivity between other motor and non-motor brain regions during the tasks.(At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.)
  • Task-related whole-brain activations.(At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).)
  • Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments(At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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