Imaging Biomarkers in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Using MRI, we will measure signal intensities of iron-rich structures using T2 sequences and calculate phase shift values in these structures with susceptibility weighted sequences. We will also measure clinical symptom severity with the UPDRS s...
研究概览
简要总结
Background:
- Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not fully understand why the brain cells that produce dopamine stop working or die in people with PD. This study will use different ways of imaging the brain and brain chemicals to look at PD. It will compare brain imaging in people who definitely have PD to people who might have PD and to people without signs of PD. It will provide more information how the brain in people with PD changes over time.
Objectives:
- To understand the changes that occur in the brains of people with Parkinson s disease.
Eligibility:
- Individuals at least 18 years of age who have definite or possible Parkinson s disease.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will have a screening visit with a physical exam and medical history.
- Participants will visit the National Institutes of Health Clinical Center every 18 month or 3 years for up to 9 years. There will be up to 6 total visits. Most visits will last 5 to 6 hours a day for 1 to 3 days.
Some or all of the following tests will be performed at each visit:
- Magnetic resonance imaging to take pictures of the brain. Some of these tests will be done at rest. Others will require participants to perform an activity during the scan.
- Medication withdrawal for 12 hours overnight for people taking PD medications. This may be done before some scans. Participants who feel unwell when they stop taking medications will be allowed to start taking them again.
- Participants will continue with the follow up visits until the end of the study.
详细描述
Objectives:
The purpose of this protocol is to evaluate possible imaging biomarkers for diagnosis and assessment of disease progression in Parkinson disease (PD) through multi-modal neuroimaging studies.
The study will have two parts:
- Part 1: Compare brain images of PD subjects and healthy volunteers (HVs) using various imaging techniques in a case-control analysis.
- Part 2: Compare findings on serial brain images with clinical assessments of clinically defined PD subjects, subjects with prodromal Parkinson disease, and healthy volunteers, over the following 9 years. The findings from this exploratory study will help develop additional hypothesis-driven studies investigating PD pathology. PD patients will yield information about how imaging outcomes change over time, and their relationship with disease progression; the patients with prodromal symptoms will give information as to which imaging modalities/analysis might predict the clinical manifestation of PD, healthy volunteers will serve as controls for subjects aging and technological changes due to scanner functioning.
Study Population:
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •For all subjects:
- •Age 18 or older.
- •Subjects must fulfill either the clinically defined PD, prodromal PD or not having any of the red flags following the MDS criteria for PD.
- •Able to give informed consent or, if there is evidence of cognitive decline, able to appoint a durable power of attorney (DPA) who can give informed consent.
排除标准
- •More than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males.
- •History of a neurologic disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, a movement disorder other than the ones under study, epilepsy or a history of seizures or any abnormal or focal finding on neurological exam other than that associated with those studied in this protocol.
- •History of any head injury with loss of consciousness
- •Pregnancy or positive pregnancy test before the research procedure due to the risks associated with MRI scans. This would exclude subjects from participating in the protocol at that time.
- •Inability to lie flat on the back for up to 2 hours
- •Claustrophobia or a feeling of discomfort from being in small, enclosed spaces.
- •Surgically or traumatically implanted metallic foreign bodies, such as pacemakers, implanted medical pumps, implanted hearing aids, metal plates in the skull or metal implants in the skull or eyes (other than dental fillings) that may be physically hazardous during an MRI, or might distort the images.
- •Ablative surgery or implanted electrodes and generator for deep brain stimulation
- •Use of the following therapies which may affect mitochondrial function: Coenzyme Q10, vitamin E, vitamin C, anti-retroviral drugs, chemotherapeutic agents, anti-epileptics agents or antibiotics. (Use ofthese substances will prevent getting MRS scan only).
- •Have uncontrolled head movements that may impair image data collection
研究组 & 干预措施
Parkinsons Disease subjects
Subjects fitting the MSD Clinical Diagnostic Criteria for PD
Healthy Volunteers
Subjects without PD diagnosis
Prodromal Parkinson disease
Subjects fitting the MDS prodromal criteria for PD
结局指标
主要结局
Using MRI, we will measure signal intensities of iron-rich structures using T2 sequences and calculate phase shift values in these structures with susceptibility weighted sequences. We will also measure clinical symptom severity with the UPDRS s...
时间窗: 10 years
-Structural MRI (SWI images): The primary outcome measure is the difference in susceptibility changes in iron-rich structures (ie. The SN, red nucleus, striatum) across groups and within groups over time.-Clinical presentation: We will evaluate how the prodromal symptoms influence the progression to clinical PD.
次要结局
- fMRI(10 years)
- Structural MR (morphometry and diffusion analyses)(10 years)
- MRS(10 years)