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 range
31 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Substantia nigra quantitative susceptibility mapping value
Timeframe: Baseline and annually for up to 5 years