NCT01547481已完成不适用
Statistical Mapping of the Brain in Progressive Supranuclear Palsy, Essential Tremor, Parkinson Disease, Parkinsonism, and REM Behavior Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- fMRI compared between cohorts
研究概览
简要总结
This proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism.
详细描述
This proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism. We focus on early diagnosis of Parkinsonism, other tremor disorders, and determine how imaging might be used to improve diagnosis. The purpose of this protocol is to gather a multi-modal dataset to explore and validate the investigator's previous research findings in prior studies.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Control • Age 35-85
- •Parkinson Disease (PD) Age 35-85
- •Diagnosis of clinically definite PD made by a movement disorders specialist, with evidence of the following features:
- •Presence of bradykinesia and 1 or both of the following:
- •Rest tremor
- •Asymmetric Onset
- •Progressive motor symptoms
- •Levodopa responsive
- •Duration at least 1 but not more than 10 years
- •Hoehn and Yahr Stage 1-2
- •Progressive Supranuclear Palsy (PSP) Age 40-85
- •Diagnosis of clinically definite PSP, with the following features:
- •Gradually progressive disorder.
- •Onset after age 39
- •Supranuclear palsy* and postural instability with falls in the first year of disease onset*.
- •No evidence of other disease.
- •Parkinsonism of Other or Undetermined Cause (POC) Age 35-85
- •Diagnosis of parkinsonism of undetermined other other cause by a movement disorders specialist, with the following features:
- •Signs and symptoms of Parkinsonism including
- •Bradykinesia
- •Mixed or resting tremor
- •Characteristic deficits of gait and balance associated with Parkinsonism
- •Essential Tremor (ET) Age 35-85
- •Diagnosis of essential tremor, with the following features:
- •A 2+ postural tremor of at least 1 arm (a head tremor may also be present, but is not sufficient for diagnosis)
- •On examination, there must be
- •a 2+ kinetic tremor during at least 4 tasks, or;
- •a 2+ kinetic tremor on 1 task and a 3+ kinetic tremor on a second task; tasks include pouring water, using a spoon to drink water, drinking water, finger-to-nose, and drawing a spiral
- •If on examination, the tremor is present in the dominant hand, then by report, it must interfere with at least 1 activity of daily living.
- •REM Behavior Disorder (RBD) Age 25 - 85
- •Documented diagnosis of REM sleep behavior disorder (RBD) by a sleep medicine specialist, with the following clinical features:
- •Presence of REM sleep without atonia on polysomnography
- •At least one of the following conditions:
- •Sleep-related, behaviors by history (eg, dream enactment behavior)
- •Abnormal REM sleep behavior documented during PSG monitoring
排除标准
- •Healthy Control
- •Pregnancy
- •First-degree blood relative affected by PD
- •Neurodegenerative disease
- •History of repeated head injury, encephalitis, brain surgery, stroke, dementia, neuroleptic exposure, or serious medical illness that may interfere with participation.
- •Parkinson Disease (PD)
- •Any exclusion criteria that would exclude a healthy control patient
- •Atypical features indicative of a Parkinson-Plus disorder
- •Progressive Supranuclear Palsy (PSP)
- •Any exclusion criteria that would exclude a healthy control patient
- •Any finding atypical for PSP
- •Neuroradiologic evidence of relevant structural abnormality unrelated to appropriate changes known to be associated with PSP
- •Parkinsonism of Other or Undetermined Cause (POC)
- •Any exclusion criteria that would exclude a healthy control patient
- •Signs and symptoms suggestive of clear diagnosis of idiopathic Parkinson disease, Progressive Supranuclear Palsy, or Essential Tremor
- •Essential Tremor (ET)
- •Any exclusion criteria that would exclude a healthy control patient
- •No other potential etiologic factors for the tremor
- •Any first-degree blood relative affected by PD
- •History of neurodegenerative disease
- •REM Behavior Disorder (RBD)
- •Any exclusion criteria that would exclude a healthy control patient
- •Sleep disorder not better explained by another sleep disorder, medical or neurological disorder, mental disorder, medication use, or substance use disorder
结局指标
主要结局
fMRI compared between cohorts
时间窗: one time at initial visit
Studying resting brain activity between healthy adults, participants with Parkinson's and participants with REM Behavior Disorder.
次要结局
未报告次要终点
研究者
Dr. Frank Michael Skidmore
Assistant Professor
University of Alabama at Birmingham
研究点 (1)
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