Parkinsonism, REM Sleep Behavior Disorder
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
31 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Substantia nigra quantitative susceptibility mapping value | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UMSARS total score | Baseline and annually for up to 5 years | Unified Multiple System Atrophy Rating Scale total score to assess motor and disease-related clinical severity. Higher scores indicate worse impairment. |
| MDS-UPDRS total score | Baseline and annually for up to 5 years | Movement Disorder Society-Unified Parkinson's Disease Rating Scale total score to assess Parkinsonian symptom severity. Higher scores indicate worse impairment. |
| PSPRS total score | Baseline and annually for up to 5 years | Progressive Supranuclear Palsy Rating Scale total score to assess disease severity in participants with PSP features. Higher scores indicate worse impairment. |
| Tinetti gait and balance test score | Baseline and annually for up to 5 years | Tinetti gait and balance test score to assess gait and balance performance. Lower scores indicate worse gait and balance function. |
| Berg Balance Scale score | Baseline and annually for up to 5 years | Berg Balance Scale score to assess balance function. Lower scores indicate worse balance. |
| Hoehn and Yahr stage | Baseline and annually for up to 5 years | Hoehn and Yahr stage to assess Parkinsonian disease stage. Higher stages indicate more advanced disease. |
| NMSQ total score | Baseline and annually for up to 5 years | Non-Motor Symptoms Questionnaire total score to assess non-motor symptom burden. Higher scores indicate greater non-motor symptom burden. |
| SCOPA-AUT total score | Baseline and annually for up to 5 years | Scales for Outcomes in Parkinson's Disease-Autonomic total score to assess autonomic dysfunction. Higher scores indicate worse autonomic symptoms. |
| SS-16 olfactory score | Baseline and annually for up to 5 years | Sniffin' Sticks 16-item olfactory identification score to assess olfactory function. Higher scores indicate better olfactory performance. |
| Wexner constipation score | Baseline and annually for up to 5 years | Wexner constipation score to assess constipation severity. Higher scores indicate worse constipation symptoms. |
| PDQ-39 total score | Baseline and annually for up to 5 years | Parkinson's Disease Questionnaire-39 total score to assess health-related quality of life. Higher scores indicate worse quality of life. |
| EAT score | Baseline and annually for up to 5 years | Eating Assessment Tool score to assess swallowing difficulty. Higher scores indicate worse swallowing symptoms. |
| RBDSQ total score | Baseline and annually for up to 5 years | Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire total score to assess REM sleep behavior disorder symptoms. Higher scores indicate worse symptom burden. |
| PSQI total score | Baseline and annually for up to 5 years | Pittsburgh Sleep Quality Index total score to assess sleep quality. Higher scores indicate worse sleep quality. |
| HAMD-17 total score | Baseline and annually for up to 5 years | 17-item Hamilton Depression Rating Scale total score to assess depressive symptoms. Higher scores indicate worse depressive symptom severity. |
| HAMA total score | Baseline and annually for up to 5 years | Hamilton Anxiety Rating Scale total score to assess anxiety symptoms. Higher scores indicate worse anxiety symptom severity. |
| MoCA score | Baseline and annually for up to 5 years | Montreal Cognitive Assessment score to assess global cognitive function. Higher scores indicate better cognitive performance. |
| MMSE score | Baseline and annually for up to 5 years | Mini-Mental State Examination score to assess global cognitive function. Higher scores indicate better cognitive performance. |
| FAB score | Baseline and annually for up to 5 years | Frontal Assessment Battery score to assess frontal executive function. Higher scores indicate better executive performance. |
| Oxyhemoglobin level during postural and motor testing | Baseline and annually for up to 5 years | Oxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response. |
| Deoxyhemoglobin level during postural and motor testing | Baseline and annually for up to 5 years | Deoxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response. |
| Total hemoglobin level during postural and motor testing | Baseline and annually for up to 5 years | Total hemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response. |
| 24-hour mean systolic blood pressure | Baseline and annually for up to 5 years | Mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg. |
| 24-hour mean diastolic blood pressure | Baseline and annually for up to 5 years | Mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg. |
| 24-hour mean heart rate | Baseline and annually for up to 5 years | Mean heart rate measured by 24-hour ambulatory blood pressure monitoring. Units: beats per minute. |
| Tremor frequency | Baseline and annually for up to 5 years | Tremor frequency measured by tremor analysis as a quantitative indicator of tremor characteristics. |
| Tremor amplitude | Baseline and annually for up to 5 years | Tremor amplitude measured by tremor analysis as a quantitative indicator of tremor severity. |
| Timed Up and Go test duration derived from wearable assessment | Baseline and annually for up to 5 years | Timed Up and Go (TUG) test duration derived from wearable device-based assessment to evaluate mobility and functional movement performance. |
| Machine vision-derived UPDRS Part III score | Baseline and annually for up to 5 years | Unified Parkinson's Disease Rating Scale Part III motor score estimated using machine vision-based video assessment to quantify motor impairment. |
| Structural MRI | Baseline and annually for up to 5 years | Prespecified structural MRI-derived quantitative measure, such as regional brain volume or cortical thickness, assessed to characterize disease-related neuroanatomical changes. |
| Resting-state functional MRI | Baseline and annually for up to 5 years | Prespecified resting-state functional MRI quantitative measure, such as functional connectivity within a predefined brain network, assessed to characterize disease-related functional brain changes. |
| Diffusion tensor imaging | Baseline and annually for up to 5 years | 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. |
| Quantitative susceptibility mapping | Baseline and annually for up to 5 years | Quantitative susceptibility mapping value measured in a prespecified brain region to assess iron-related imaging changes. |
| Neuromelanin-sensitive MRI | Baseline and annually for up to 5 years | Neuromelanin-sensitive magnetic resonance imaging signal intensity measured in a prespecified brain region to assess disease-related imaging changes. |
| Tau PET/MR | Baseline and annually for up to 5 years | Standardized uptake value ratio measured by tau PET/MR in a prespecified brain region using a prespecified tau tracer to assess tau-related signal. |
| DAT PET/MR | Baseline and annually for up to 5 years | Standardized uptake value ratio measured by dopamine transporter PET/MR in a prespecified brain region to assess dopaminergic terminal integrity. |
| FDG PET/MR | Baseline and annually for up to 5 years | Standardized uptake value ratio measured by FDG PET/MR in a prespecified brain region to assess regional glucose metabolism. |
| Mean cerebral blood flow velocity during postural testing | Baseline and annually for up to 5 years | 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. |
| Heart rate during postural testing with continuous hemodynamic monitoring | Baseline and annually for up to 5 years | 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. |
| Quantitative speech parameter from standardized speech assessment | Baseline and annually for up to 5 years | Quantitative speech parameter measured during standardized speech assessment performed in a sound-controlled room to evaluate speech-related changes associated with Parkinsonism. |
| Quantitative high-density electroencephalography parameter | Baseline and annually for up to 5 years | Quantitative parameter derived from 64-channel high-density electroencephalography to assess neurophysiological changes associated with disease progression. |
| Quantitative polysomnography parameter | Baseline and annually for up to 5 years | Quantitative parameter derived from respiratory sleep monitoring to assess sleep-related physiological abnormalities during follow-up. |
| Quantitative paired transcranial stimulation parameter | Baseline and annually for up to 5 years | Quantitative parameter derived from paired transcranial stimulation to assess cortical excitability and related neurophysiological changes. |
| Quantitative blood biomarker level | Baseline and annually for up to 5 years | Quantitative level of a prespecified blood biomarker measured in biospecimens collected during follow-up to assess biological changes associated with disease progression. |
Countries
China
Contacts
CONTACTJun Liu, Professor
Outcome results
None listed