A Multimodal Prospective Cohort Study of Parkinsonism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age31-79
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants will include patients with Parkinsonism, patients with rapid eye movement sleep behavior disorder, and healthy controls. Patients will be mainly recruited from the inpatient wards of the Department of Neurology at Ruijin Hospital after diagnostic and eligibility screening. Healthy controls will be recruited mainly from patients' family members or the community.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
640 Participants
are grouped into 3 trial groupsGroup A: Parkinsonism
Group B: REM Sleep Behavior Disorder
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
Substantia nigra quantitative susceptibility mapping value
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 yearsSecondary outcomes
1
UMSARS total score
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 years2
MDS-UPDRS total score
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 years3
PSPRS total score
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 years4
Tinetti gait and balance test score
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 yearsSponsors and contacts
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Source ClinicalTrials.gov