Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Location status: Recruiting
NCT Number: NCT07553845
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.
Interested in participating?
Request Info31 year–79 year
All sexes
Observational
Shanghai, 200025, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants with rapid eye movement sleep behavior disorder:
For participants with Parkinsonism:
For healthy controls:
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Berg Balance Scale score to assess balance function. Lower scores indicate worse balance.
Time frame: Baseline and annually for up to 5 years
Hoehn and Yahr stage to assess Parkinsonian disease stage. Higher stages indicate more advanced disease.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Wexner constipation score to assess constipation severity. Higher scores indicate worse constipation symptoms.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Eating Assessment Tool score to assess swallowing difficulty. Higher scores indicate worse swallowing symptoms.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Pittsburgh Sleep Quality Index total score to assess sleep quality. Higher scores indicate worse sleep quality.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Montreal Cognitive Assessment score to assess global cognitive function. Higher scores indicate better cognitive performance.
Time frame: Baseline and annually for up to 5 years
Mini-Mental State Examination score to assess global cognitive function. Higher scores indicate better cognitive performance.
Time frame: Baseline and annually for up to 5 years
Frontal Assessment Battery score to assess frontal executive function. Higher scores indicate better executive performance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg.
Time frame: Baseline and annually for up to 5 years
Mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg.
Time frame: Baseline and annually for up to 5 years
Mean heart rate measured by 24-hour ambulatory blood pressure monitoring. Units: beats per minute.
Time frame: Baseline and annually for up to 5 years
Tremor frequency measured by tremor analysis as a quantitative indicator of tremor characteristics.
Time frame: Baseline and annually for up to 5 years
Tremor amplitude measured by tremor analysis as a quantitative indicator of tremor severity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Quantitative susceptibility mapping value measured in a prespecified brain region to assess iron-related imaging changes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and annually for up to 5 years
Quantitative parameter derived from respiratory sleep monitoring to assess sleep-related physiological abnormalities during follow-up.
Time frame: Baseline and annually for up to 5 years
Quantitative parameter derived from paired transcranial stimulation to assess cortical excitability and related neurophysiological changes.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
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