Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Substantia nigra quantitative susceptibility mapping value | Quantitative susceptibility mapping (QSM) value measured in the substantia nigra by neuroimaging to assess disease-related imaging changes. | Baseline and annually for up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| UMSARS total score | Unified Multiple System Atrophy Rating Scale total score to assess motor and disease-related clinical severity. Higher scores indicate worse impairment. | Baseline and annually for up to 5 years |
| MDS-UPDRS total score |
Not provided
Inclusion Criteria:
For participants with rapid eye movement sleep behavior disorder:
For participants with Parkinsonism:
For healthy controls:
Exclusion Criteria:
Not provided
Not provided
Participants will include patients with Parkinsonism, patients with rapid eye movement sleep behavior disorder, and healthy controls. Patients will be mainly recruited from the inpatient wards of the Department of Neurology at Ruijin Hospital after diagnostic and eligibility screening. Healthy controls will be recruited mainly from patients' family members or the community.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, Professor | Contact | +86-021-64370045 | lj11128@rjh.com.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples will be collected and retained in the form of plasma and blood cells. Retained biospecimens may be used for future analyses of blood biomarkers, DNA, RNA, proteins, and metabolites.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale total score to assess Parkinsonian symptom severity. Higher scores indicate worse impairment.
| Baseline and annually for up to 5 years |
| PSPRS total score | Progressive Supranuclear Palsy Rating Scale total score to assess disease severity in participants with PSP features. Higher scores indicate worse impairment. | Baseline and annually for up to 5 years |
| Tinetti gait and balance test score | Tinetti gait and balance test score to assess gait and balance performance. Lower scores indicate worse gait and balance function. | Baseline and annually for up to 5 years |
| Berg Balance Scale score | Berg Balance Scale score to assess balance function. Lower scores indicate worse balance. | Baseline and annually for up to 5 years |
| Hoehn and Yahr stage | Hoehn and Yahr stage to assess Parkinsonian disease stage. Higher stages indicate more advanced disease. | Baseline and annually for up to 5 years |
| NMSQ total score | Non-Motor Symptoms Questionnaire total score to assess non-motor symptom burden. Higher scores indicate greater non-motor symptom burden. | Baseline and annually for up to 5 years |
| SCOPA-AUT total score | Scales for Outcomes in Parkinson's Disease-Autonomic total score to assess autonomic dysfunction. Higher scores indicate worse autonomic symptoms. | Baseline and annually for up to 5 years |
| SS-16 olfactory score | Sniffin' Sticks 16-item olfactory identification score to assess olfactory function. Higher scores indicate better olfactory performance. | Baseline and annually for up to 5 years |
| Wexner constipation score | Wexner constipation score to assess constipation severity. Higher scores indicate worse constipation symptoms. | Baseline and annually for up to 5 years |
| PDQ-39 total score | Parkinson's Disease Questionnaire-39 total score to assess health-related quality of life. Higher scores indicate worse quality of life. | Baseline and annually for up to 5 years |
| EAT score | Eating Assessment Tool score to assess swallowing difficulty. Higher scores indicate worse swallowing symptoms. | Baseline and annually for up to 5 years |
| RBDSQ total score | Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire total score to assess REM sleep behavior disorder symptoms. Higher scores indicate worse symptom burden. | Baseline and annually for up to 5 years |
| PSQI total score | Pittsburgh Sleep Quality Index total score to assess sleep quality. Higher scores indicate worse sleep quality. | Baseline and annually for up to 5 years |
| HAMD-17 total score | 17-item Hamilton Depression Rating Scale total score to assess depressive symptoms. Higher scores indicate worse depressive symptom severity. | Baseline and annually for up to 5 years |
| HAMA total score | Hamilton Anxiety Rating Scale total score to assess anxiety symptoms. Higher scores indicate worse anxiety symptom severity. | Baseline and annually for up to 5 years |
| MoCA score | Montreal Cognitive Assessment score to assess global cognitive function. Higher scores indicate better cognitive performance. | Baseline and annually for up to 5 years |
| MMSE score | Mini-Mental State Examination score to assess global cognitive function. Higher scores indicate better cognitive performance. | Baseline and annually for up to 5 years |
| FAB score | Frontal Assessment Battery score to assess frontal executive function. Higher scores indicate better executive performance. | Baseline and annually for up to 5 years |
| Oxyhemoglobin level during postural and motor testing | Oxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response. | Baseline and annually for up to 5 years |
| Deoxyhemoglobin level during postural and motor testing | Deoxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response. | Baseline and annually for up to 5 years |
| Total hemoglobin level during postural and motor testing | Total hemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response. | Baseline and annually for up to 5 years |
| 24-hour mean systolic blood pressure | Mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg. | Baseline and annually for up to 5 years |
| 24-hour mean diastolic blood pressure | Mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg. | Baseline and annually for up to 5 years |
| 24-hour mean heart rate | Mean heart rate measured by 24-hour ambulatory blood pressure monitoring. Units: beats per minute. | Baseline and annually for up to 5 years |
| Tremor frequency | Tremor frequency measured by tremor analysis as a quantitative indicator of tremor characteristics. | Baseline and annually for up to 5 years |
| Tremor amplitude | Tremor amplitude measured by tremor analysis as a quantitative indicator of tremor severity. | Baseline and annually for up to 5 years |
| Timed Up and Go test duration derived from wearable assessment | Timed Up and Go (TUG) test duration derived from wearable device-based assessment to evaluate mobility and functional movement performance. | Baseline and annually for up to 5 years |
| Machine vision-derived UPDRS Part III score | Unified Parkinson's Disease Rating Scale Part III motor score estimated using machine vision-based video assessment to quantify motor impairment. | Baseline and annually for up to 5 years |
| Structural MRI | Prespecified structural MRI-derived quantitative measure, such as regional brain volume or cortical thickness, assessed to characterize disease-related neuroanatomical changes. | Baseline and annually for up to 5 years |
| Resting-state functional MRI | Prespecified resting-state functional MRI quantitative measure, such as functional connectivity within a predefined brain network, assessed to characterize disease-related functional brain changes. | Baseline and annually for up to 5 years |
| Diffusion tensor imaging | Prespecified diffusion tensor imaging quantitative parameter, such as fractional anisotropy or mean diffusivity in a predefined tract or region of interest, assessed to characterize microstructural changes. | Baseline and annually for up to 5 years |
| Quantitative susceptibility mapping | Quantitative susceptibility mapping value measured in a prespecified brain region to assess iron-related imaging changes. | Baseline and annually for up to 5 years |
| Neuromelanin-sensitive MRI | Neuromelanin-sensitive magnetic resonance imaging signal intensity measured in a prespecified brain region to assess disease-related imaging changes. | Baseline and annually for up to 5 years |
| Tau PET/MR | Standardized uptake value ratio measured by tau PET/MR in a prespecified brain region using a prespecified tau tracer to assess tau-related signal. | Baseline and annually for up to 5 years |
| DAT PET/MR | Standardized uptake value ratio measured by dopamine transporter PET/MR in a prespecified brain region to assess dopaminergic terminal integrity. | Baseline and annually for up to 5 years |
| FDG PET/MR | Standardized uptake value ratio measured by FDG PET/MR in a prespecified brain region to assess regional glucose metabolism. | Baseline and annually for up to 5 years |
| Mean cerebral blood flow velocity during postural testing | Mean cerebral blood flow velocity measured during postural testing using continuous cerebral blood flow monitoring and transcranial Doppler ultrasonography to assess hemodynamic changes associated with postural challenge. | Baseline and annually for up to 5 years |
| Heart rate during postural testing with continuous hemodynamic monitoring | Heart rate measured during postural testing using continuous hemodynamic monitoring performed together with transcranial Doppler ultrasonography to assess autonomic and hemodynamic responses to postural challenge. | Baseline and annually for up to 5 years |
| Quantitative speech parameter from standardized speech assessment | Quantitative speech parameter measured during standardized speech assessment performed in a sound-controlled room to evaluate speech-related changes associated with Parkinsonism. | Baseline and annually for up to 5 years |
| Quantitative high-density electroencephalography parameter | Quantitative parameter derived from 64-channel high-density electroencephalography to assess neurophysiological changes associated with disease progression. | Baseline and annually for up to 5 years |
| Quantitative polysomnography parameter | Quantitative parameter derived from respiratory sleep monitoring to assess sleep-related physiological abnormalities during follow-up. | Baseline and annually for up to 5 years |
| Quantitative paired transcranial stimulation parameter | Quantitative parameter derived from paired transcranial stimulation to assess cortical excitability and related neurophysiological changes. | Baseline and annually for up to 5 years |
| Quantitative blood biomarker level | Quantitative level of a prespecified blood biomarker measured in biospecimens collected during follow-up to assess biological changes associated with disease progression. | Baseline and annually for up to 5 years |
| D009069 | Movement Disorders |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |