Multimodal prospective cohort of Parkinsonism
A Multimodal Prospective Cohort Study of Parkinsonism
This project will try to track disease progression and improve diagnosis using imaging, clinical tests, and biological samples in people with parkinsonism, people with REM sleep behavior disorder, and healthy volunteers over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 640 (estimated) |
| Ages | 31 Years to 79 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07553845 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational cohort enrolling 400 participants with parkinsonism, 120 with REM sleep behavior disorder (RBD), and 120 healthy controls with five years of follow-up. Participants will undergo multimodal assessments including neuroimaging, clinical rating scales, blood and other biological samples, cerebral blood flow testing, neurophysiology, tremor analysis, and voice/video recordings. The study aims to characterize longitudinal progression, identify factors linked to conversion from RBD to parkinsonism, and improve differentiation among parkinsonian disorders. All procedures are observational and designed to build biomarkers and diagnostic signatures rather than test an experimental treatment.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults aged over 30 and under 80 who can provide informed consent and either meet standard diagnostic criteria for parkinsonism or for RBD, or are healthy controls without neurological disease.
Not a fit: People outside the 30–80 age range, non-Chinese citizens, those unable to comply with repeated visits or follow-up, or individuals with severe comorbidities or contraindications to imaging are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could help clinicians diagnose different parkinsonian disorders earlier and predict which people with RBD are likely to develop parkinsonism.
How similar studies have performed: Similar longitudinal multimodal cohort studies in Parkinson's disease and RBD have shown some success in identifying potential biomarkers and predictors of conversion, though robust, universally accepted diagnostic markers are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jun Liu, Professor
- Email: lj11128@rjh.com.cn
- Phone: +86-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.