A Multimodal Prospective Cohort Study of Parkinsonism (NCT07553845) | Clinical Trial Compass
RecruitingNot Applicable
A Multimodal Prospective Cohort Study of Parkinsonism
China640 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range31 Years – 79 Years
SexALL
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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 par…
What they're measuring
1
Substantia nigra quantitative susceptibility mapping value
Timeframe: Baseline and annually for up to 5 years