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A Multimodal Prospective Cohort Study of Parkinsonism

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 31
Maximum Age: 79
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
China
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Jun Liu, Professor
lj11128@rjh.com.cn
+86-021-64370045
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2029-05
Participants
Target number of participants: 640
Treatments
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.
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov