An observational study in Parkinson's Disease (PD) and Multiple System Atrophy, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Ruijin Hospital · Observational
Among 20 studies in Parkinson Disease by Ruijin Hospital — 9 open to participants now, 9 under way, none of them phase 3. Parkinson Disease · Ruijin Hospital.
Among the 20 studies in Parkinson Disease by Ruijin Hospital, this one is one of 5 that started in 2025, is one of 2 observational ones, and was the 17th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 700 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →9 of the 20 studies in Parkinson Disease by Ruijin Hospital are open now, in 1 country. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2025.
Median enrollment 30 across the 18 interventional studies, 360 across the 2 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
3 of the studies in Parkinson Disease by Ruijin Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07018388Ruijin HospitalIntrapatient Comparison of STN and GPi tTIS in PD | 2026-11-01 |
| NCT07353463Ruijin HospitalShanghai Clinical Cohort - Parkinson's Disease (Reserve) | 2026-12-31 |
| NCT07774312Ruijin HospitalSTN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease | 2027-03-15 |
Among the 20 studies in Parkinson Disease by Ruijin Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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
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.
Inclusion Criteria for Clinical PD Group:
Inclusion Criteria for Clinical MSA Group:
Exclusion Criteria for All Participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From baseline through 6-month and 12-month follow-up assessments
Plan to share: No
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