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| ID | Type | Description | Link |
|---|---|---|---|
| SHDC2025CCS043 | Other Grant/Funding Number | Shanghai Shenkang Hospital Development Center |
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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Shanghai Sunshine Rehabilitation Center | OTHER |
| Longhua Hospital | OTHER |
| Shanghai Municipal Hospital of Traditional Chinese Medicine |
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The goal of this observational cohort studyis to establish a high-quality clinical cohort of Parkinson's disease (PD) and multiple system atrophy (MSA) patients in Shanghai, in order to improve early diagnosis, precise subtyping, disease monitoring, and to provide a resource for translational research and novel therapy development.
The main questions it aims to answer are:
Participants will:
This study will create a sustainable, multicenter, and sharable cohort platform to support early identification, personalized intervention, and therapeutic development for neurodegenerative diseases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease Cohort | This cohort will include approximately 600 patients diagnosed with Parkinson's disease according to established Chinese diagnostic criteria. Participants will undergo standardized clinical assessments of motor and non-motor symptoms, neuroimaging (MRI, optional PET/SPECT), electrophysiological recordings, and collection of biospecimens (blood, saliva, optional CSF). Longitudinal follow-up will be conducted every 6 months to monitor disease progression and treatment response. | ||
| Multiple System Atrophy Cohort | This cohort will include approximately 100 patients with clinically diagnosed or probable multiple system atrophy, based on Chinese expert consensus criteria. Participants will undergo comprehensive clinical evaluation, neuroimaging, electrophysiological testing, and biospecimen collection (blood, saliva, optional CSF). Regular follow-up every 6 months will capture disease progression, functional decline, and potential biomarkers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in motor symptom severity assessed by MDS-UPDRS Part III | Motor symptom severity will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III; range 0-132, higher scores indicate worse motor impairment). The primary outcome is the change from baseline score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Hoehn & Yahr stage | Disease severity will be assessed using the Hoehn & Yahr staging scale, which classifies Parkinson's disease severity on a scale from Stage 1 to Stage 5, with higher stages indicating more advanced disease. The secondary outcome is the change in Hoehn & Yahr stage from baseline. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Brief Pain Inventory (BPI) pain severity score | Pain severity will be assessed using the Brief Pain Inventory (BPI) pain severity subscale, with scores ranging from 0 to 10. Higher scores indicate more severe pain. The secondary outcome is the change from baseline in BPI pain severity score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK) score | REM sleep behavior disorder symptoms will be assessed using the REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK), with total scores ranging from 0 to 100. Higher scores indicate more severe RBD symptoms. The secondary outcome is the change from baseline in RBDQ-HK score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLSS) score | Restless legs syndrome symptom severity will be assessed using the International Restless Legs Syndrome Study Group Rating Scale (IRLSS), with scores ranging from 0 to 40. Higher scores indicate more severe symptoms. The secondary outcome is the change from baseline in IRLSS score. |
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Inclusion Criteria for Clinical PD Group:
Inclusion Criteria for Clinical MSA Group:
Exclusion Criteria for All Participants:
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The study population consists of patients with Parkinson's disease (PD) and multiple system atrophy (MSA) recruited from outpatient and inpatient clinics at Ruijin Hospital and collaborating tertiary medical centers in Shanghai. Approximately 600 clinically diagnosed PD patients and 100 clinically diagnosed or probable MSA patients will be enrolled. All participants must meet established Chinese diagnostic criteria, agree to provide biospecimens (blood, saliva, optional CSF), undergo neuroimaging and electrophysiological testing, and complete standardized clinical assessments. Patients with unclear diagnoses, significant comorbidities, or poor compliance will be excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, Professor | Contact | +86-021-64370045 | lj11128@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
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The study will retain multiple types of biospecimens, including:
Blood samples (whole blood, serum, plasma, DNA extraction) Saliva samples Cerebrospinal fluid (CSF) (optional, with patient consent)
| From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score | Olfactory function will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT), with scores ranging from 0 to 40. Lower scores indicate worse olfactory function. The secondary outcome is the change from baseline in UPSIT score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) score | Autonomic dysfunction will be assessed using the Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), with total scores ranging from 0 to 69. Higher scores indicate more severe autonomic dysfunction. The secondary outcome is the change from baseline in SCOPA-AUT score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Epworth Sleepiness Scale (ESS) score | Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), with scores ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The secondary outcome is the change from baseline in ESS score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. The secondary outcome is the change from baseline in PSQI score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Hamilton Anxiety Rating Scale (HAMA) score | Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAMA), with total scores ranging from 0 to 56. Higher scores indicate more severe anxiety. The secondary outcome is the change from baseline in HAMA score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) score | Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17), with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. The secondary outcome is the change from baseline in HAMD-17 score. | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Non-Motor Symptoms Scale (NMSS) total score | Non-motor symptom burden will be assessed using the Non-Motor Symptoms Scale (NMSS), with total scores ranging from 0 to 360. Higher scores indicate greater severity of non-motor symptoms. The secondary outcome is the change from baseline in NMSS total score | From baseline through 6-month and 12-month follow-up assessments |
| Change from baseline in Montreal Cognitive Assessment (MoCA) score | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), with scores ranging from 0 to 30. Lower scores indicate worse cognitive performance. The secondary outcome is the change from baseline in MoCA score. | From baseline through 6-month and 12-month follow-up assessments |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |