A Multimodal Prospective Cohort Study of Parkinsonism

Overview

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.

Primary outcome measures

• Substantia nigra quantitative susceptibility mapping value [Time frame: Baseline and annually for up to 5 years]

Secondary outcome measures (12)

• UMSARS total score [Time frame: Baseline and annually for up to 5 years]
• MDS-UPDRS total score [Time frame: Baseline and annually for up to 5 years]
• PSPRS total score [Time frame: Baseline and annually for up to 5 years]
• Tinetti gait and balance test score [Time frame: Baseline and annually for up to 5 years]
• Berg Balance Scale score [Time frame: Baseline and annually for up to 5 years]
• Hoehn and Yahr stage [Time frame: Baseline and annually for up to 5 years]
• NMSQ total score [Time frame: Baseline and annually for up to 5 years]
• SCOPA-AUT total score [Time frame: Baseline and annually for up to 5 years]
• SS-16 olfactory score [Time frame: Baseline and annually for up to 5 years]
• Wexner constipation score [Time frame: Baseline and annually for up to 5 years]
• PDQ-39 total score [Time frame: Baseline and annually for up to 5 years]
• EAT score [Time frame: Baseline and annually for up to 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07553845 · Multimodal Parkinsonism Cohort

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗