Actively Recruiting
A Multimodal Prospective Cohort Study of Parkinsonism
Led by Ruijin Hospital · Updated on 2026-04-28
640
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, prospective observational study to better understand Parkinsonism and related disorders. The study will follow 400 patients with Parkinsonism, 120 patients with rapid eye movement sleep behavior disorder, and 120 healthy controls over five years. The goal is to track disease progression, improve differential diagnosis, and explore what factors may lead from sleep behavior disorder to Parkinsonism. Participants will undergo a range of assessments including neuroimaging, clinical rating scales, blood and biological sample collection, blood flow evaluations, neurophysiological tests, tremor analysis, and voice and video recordings. These evaluations will be repeated annually throughout the follow-up period. The study includes separate groups for Parkinsonism patients, those with rapid eye movement sleep behavior disorder, and healthy controls for comparison. During the study, participants will be monitored through multiple tests such as MRI scans, PET/MR imaging, clinical scoring systems, and wearable devices to measure movement and tremor. Blood pressure, heart rate, cognitive function, sleep quality, and other neurological and physiological parameters will be tracked annually. The primary outcome focuses on measuring changes in the substantia nigra using quantitative susceptibility mapping. Safety and adherence will be maintained through regular evaluations over the five-year study duration.
CONDITIONS
Brief Title
A Multimodal Prospective Cohort Study of Parkinsonism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For participants with rapid eye movement sleep behavior disorder: meets diagnostic criteria by the American Academy of Sleep Medicine
- For participants with Parkinsonism: meets diagnostic criteria by the International Parkinson and Movement Disorder Society
- Chinese citizen
- Age over 30 years and under 80 years
- Able to understand the study and comply with procedures
- Able to provide written informed consent personally or through a legal representative
- For healthy controls: no neurodegenerative disease, no history of head trauma or surgery, stroke, epilepsy, tumor, or psychiatric disease
- No metal implants or cardiac pacemaker
- No severe chronic disease or severe liver or kidney insufficiency
- Education level of primary school or above
You will not qualify if you...
- Significant cognitive impairment (MMSE score 23 or below)
- Unable to sign informed consent or complete study procedures for other reasons
- Any other condition making participation unsuitable in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment
Participants undergo multimodal assessments including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments to evaluate their condition.
1 visit (in-person)
Duration - Up to 5 years
Participants are followed up annually to repeat multimodal assessments and monitor progression or changes in their condition.
Annual visits for up to 5 years
Trial Site Locations
Total: 1 location
1
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
Research Team
J
Jun Liu, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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