A Multimodal Prospective Cohort Study of Parkinsonism

NCT07553845 | Recruiting DMC

• 1 other identifier: Multimodal Parkinsonism Cohort
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinsonism; REM Sleep Behavior Disorder

Outcome Measures

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.

  Baseline and annually for up to 5 years

Secondary Outcomes (44)

• UMSARS total score

  Baseline and annually for up to 5 years

• MDS-UPDRS total score

  Baseline and annually for up to 5 years

• PSPRS total score

  Baseline and annually for up to 5 years

• Tinetti gait and balance test score

  Baseline and annually for up to 5 years

• Berg Balance Scale score

  Baseline and annually for up to 5 years

Study Arms (3)

Parkinsonism

Participants with Parkinsonism who meet the study eligibility criteria. This cohort includes patients diagnosed according to the International Parkinson and Movement Disorder Society criteria. Participants will undergo multimodal assessments, including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments during follow-up.

REM Sleep Behavior Disorder

Participants with rapid eye movement sleep behavior disorder who meet the study eligibility criteria. Participants will undergo multimodal assessments, including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments during follow-up to evaluate progression toward Parkinsonism.

Healthy Controls

Healthy control participants who meet the study eligibility criteria and have no major neurological disorders. Participants will undergo the same multimodal assessments as the disease cohorts for comparison, including neuroimaging, clinical rating scales, biospecimen collection, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments.

Eligibility Criteria

• Age: 31 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and retained in the form of plasma and blood cells. Retained biospecimens may be used for future analyses of blood biomarkers, DNA, RNA, proteins, and metabolites.

MeSH Terms

Conditions

Parkinsonian Disorders; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

Jun Liu, Professor

CONTACT

+86-021-64370045; lj11128@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)