A Multimodal Prospective Cohort Study of Parkinsonism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Substantia nigra quantitative susceptibility mapping value
研究概览
简要总结
This is a single-center, prospective, observational cohort study designed to investigate the progression and differential diagnosis of Parkinsonism using a multimodal approach. The study plans to enroll 400 patients with Parkinsonism, 120 patients with rapid eye movement sleep behavior disorder, and 120 healthy controls, with follow-up for 5 years.
Assessments will include neuroimaging, clinical rating scales, biological samples, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments. The study aims to characterize disease progression, explore factors associated with progression from rapid eye movement sleep behavior disorder to Parkinsonism, and improve the ability to distinguish among different Parkinsonian disorders.
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
- 31 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For participants with rapid eye movement sleep behavior disorder:
- •Meets the diagnostic criteria for rapid eye movement sleep behavior disorder established by the American Academy of Sleep Medicine
- •Chinese citizen
- •Age >30 years and <80 years
- •Able to understand the study, show good compliance, and provide written informed consent personally or through a legal representative
- •For participants with Parkinsonism:
- •Meets the diagnostic criteria for Parkinsonism established by the International Parkinson and Movement Disorder Society
- •Chinese citizen
- •Age >30 years and <80 years
- •Able to understand the study, show good compliance, and provide written informed consent personally or through a legal representative
- •For healthy controls:
- •No neurodegenerative disease, no history of head trauma or head surgery, no history of stroke, epilepsy, tumor, or psychiatric disease
- •No metal implants or cardiac pacemaker
- •No severe chronic disease or severe hepatic or renal insufficiency
- •Chinese citizen
- •Age >30 years and <80 years
- •Education level of primary school or above
- •Able to understand the study, show good compliance, and provide written informed consent personally or through a legal representative
排除标准
- •Significant cognitive impairment (MMSE ≤23)
- •Unable to sign the informed consent form or unable to complete study procedures for other reasons
- •Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study
研究组 & 干预措施
Parkinsonism
Participants with Parkinsonism who meet the study eligibility criteria. This cohort includes patients diagnosed according to the International Parkinson and Movement Disorder Society criteria. Participants will undergo multimodal assessments, including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments during follow-up.
REM Sleep Behavior Disorder
Participants with rapid eye movement sleep behavior disorder who meet the study eligibility criteria. Participants will undergo multimodal assessments, including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments during follow-up to evaluate progression toward Parkinsonism.
Healthy Controls
Healthy control participants who meet the study eligibility criteria and have no major neurological disorders. Participants will undergo the same multimodal assessments as the disease cohorts for comparison, including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments.
结局指标
主要结局
Substantia nigra quantitative susceptibility mapping value
时间窗: Baseline and annually for up to 5 years
Quantitative susceptibility mapping (QSM) value measured in the substantia nigra by neuroimaging to assess disease-related imaging changes.
次要结局
- UMSARS total score(Baseline and annually for up to 5 years)
- MDS-UPDRS total score(Baseline and annually for up to 5 years)
- PSPRS total score(Baseline and annually for up to 5 years)
- Tinetti gait and balance test score(Baseline and annually for up to 5 years)
- Berg Balance Scale score(Baseline and annually for up to 5 years)
- Hoehn and Yahr stage(Baseline and annually for up to 5 years)
- NMSQ total score(Baseline and annually for up to 5 years)
- SCOPA-AUT total score(Baseline and annually for up to 5 years)
- SS-16 olfactory score(Baseline and annually for up to 5 years)
- Wexner constipation score(Baseline and annually for up to 5 years)
- PDQ-39 total score(Baseline and annually for up to 5 years)
- EAT score(Baseline and annually for up to 5 years)
- RBDSQ total score(Baseline and annually for up to 5 years)
- PSQI total score(Baseline and annually for up to 5 years)
- HAMD-17 total score(Baseline and annually for up to 5 years)
- HAMA total score(Baseline and annually for up to 5 years)
- MoCA score(Baseline and annually for up to 5 years)
- MMSE score(Baseline and annually for up to 5 years)
- FAB score(Baseline and annually for up to 5 years)
- Oxyhemoglobin level during postural and motor testing(Baseline and annually for up to 5 years)
- Deoxyhemoglobin level during postural and motor testing(Baseline and annually for up to 5 years)
- Total hemoglobin level during postural and motor testing(Baseline and annually for up to 5 years)
- 24-hour mean systolic blood pressure(Baseline and annually for up to 5 years)
- 24-hour mean diastolic blood pressure(Baseline and annually for up to 5 years)
- 24-hour mean heart rate(Baseline and annually for up to 5 years)
- Tremor frequency(Baseline and annually for up to 5 years)
- Tremor amplitude(Baseline and annually for up to 5 years)
- Timed Up and Go test duration derived from wearable assessment(Baseline and annually for up to 5 years)
- Machine vision-derived UPDRS Part III score(Baseline and annually for up to 5 years)
- Structural MRI(Baseline and annually for up to 5 years)
- Resting-state functional MRI(Baseline and annually for up to 5 years)
- Diffusion tensor imaging(Baseline and annually for up to 5 years)
- Quantitative susceptibility mapping(Baseline and annually for up to 5 years)
- Neuromelanin-sensitive MRI(Baseline and annually for up to 5 years)
- Tau PET/MR(Baseline and annually for up to 5 years)
- DAT PET/MR(Baseline and annually for up to 5 years)
- FDG PET/MR(Baseline and annually for up to 5 years)
- Mean cerebral blood flow velocity during postural testing(Baseline and annually for up to 5 years)
- Heart rate during postural testing with continuous hemodynamic monitoring(Baseline and annually for up to 5 years)
- Quantitative speech parameter from standardized speech assessment(Baseline and annually for up to 5 years)
- Quantitative high-density electroencephalography parameter(Baseline and annually for up to 5 years)
- Quantitative polysomnography parameter(Baseline and annually for up to 5 years)
- Quantitative paired transcranial stimulation parameter(Baseline and annually for up to 5 years)
- Quantitative blood biomarker level(Baseline and annually for up to 5 years)