ParkinsonismNCT07553845
A Multimodal Prospective Cohort Study of Parkinsonism
An observational study of Parkinsonism and REM Sleep Behavior Disorder, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 31 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinsonism, REM Sleep Behavior Disorder
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to May 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
About this study
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
- Medical subject headings
- Parkinsonian Disorders, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substantia nigra quantitative susceptibility mapping value
Quantitative susceptibility mapping (QSM) value measured in the substantia nigra by neuroimaging to assess disease-related imaging changes.
Measured: Baseline and annually for up to 5 years
Secondary outcomes (44)
UMSARS total score
Unified Multiple System Atrophy Rating Scale total score to assess motor and disease-related clinical severity. Higher scores indicate worse impairment.
Measured: Baseline and annually for up to 5 years
MDS-UPDRS total score
Movement Disorder Society-Unified Parkinson's Disease Rating Scale total score to assess Parkinsonian symptom severity. Higher scores indicate worse impairment.
Measured: Baseline and annually for up to 5 years
PSPRS total score
Progressive Supranuclear Palsy Rating Scale total score to assess disease severity in participants with PSP features. Higher scores indicate worse impairment.
Measured: Baseline and annually for up to 5 years
Tinetti gait and balance test score
Tinetti gait and balance test score to assess gait and balance performance. Lower scores indicate worse gait and balance function.
Measured: Baseline and annually for up to 5 years
Berg Balance Scale score
Berg Balance Scale score to assess balance function. Lower scores indicate worse balance.
Measured: Baseline and annually for up to 5 years
Hoehn and Yahr stage
Hoehn and Yahr stage to assess Parkinsonian disease stage. Higher stages indicate more advanced disease.
Measured: Baseline and annually for up to 5 years
NMSQ total score
Non-Motor Symptoms Questionnaire total score to assess non-motor symptom burden. Higher scores indicate greater non-motor symptom burden.
Measured: Baseline and annually for up to 5 years
SCOPA-AUT total score
Scales for Outcomes in Parkinson's Disease-Autonomic total score to assess autonomic dysfunction. Higher scores indicate worse autonomic symptoms.
Measured: Baseline and annually for up to 5 years
SS-16 olfactory score
Sniffin' Sticks 16-item olfactory identification score to assess olfactory function. Higher scores indicate better olfactory performance.
Measured: Baseline and annually for up to 5 years
Wexner constipation score
Wexner constipation score to assess constipation severity. Higher scores indicate worse constipation symptoms.
Measured: Baseline and annually for up to 5 years
PDQ-39 total score
Parkinson's Disease Questionnaire-39 total score to assess health-related quality of life. Higher scores indicate worse quality of life.
Measured: Baseline and annually for up to 5 years
EAT score
Eating Assessment Tool score to assess swallowing difficulty. Higher scores indicate worse swallowing symptoms.
Measured: Baseline and annually for up to 5 years
RBDSQ total score
Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire total score to assess REM sleep behavior disorder symptoms. Higher scores indicate worse symptom burden.
Measured: Baseline and annually for up to 5 years
PSQI total score
Pittsburgh Sleep Quality Index total score to assess sleep quality. Higher scores indicate worse sleep quality.
Measured: Baseline and annually for up to 5 years
HAMD-17 total score
17-item Hamilton Depression Rating Scale total score to assess depressive symptoms. Higher scores indicate worse depressive symptom severity.
Measured: Baseline and annually for up to 5 years
HAMA total score
Hamilton Anxiety Rating Scale total score to assess anxiety symptoms. Higher scores indicate worse anxiety symptom severity.
Measured: Baseline and annually for up to 5 years
MoCA score
Montreal Cognitive Assessment score to assess global cognitive function. Higher scores indicate better cognitive performance.
Measured: Baseline and annually for up to 5 years
MMSE score
Mini-Mental State Examination score to assess global cognitive function. Higher scores indicate better cognitive performance.
Measured: Baseline and annually for up to 5 years
FAB score
Frontal Assessment Battery score to assess frontal executive function. Higher scores indicate better executive performance.
Measured: Baseline and annually for up to 5 years
Oxyhemoglobin level during postural and motor testing
Oxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response.
Measured: Baseline and annually for up to 5 years
Deoxyhemoglobin level during postural and motor testing
Deoxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response.
Measured: Baseline and annually for up to 5 years
Total hemoglobin level during postural and motor testing
Total hemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response.
Measured: Baseline and annually for up to 5 years
24-hour mean systolic blood pressure
Mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg.
Measured: Baseline and annually for up to 5 years
24-hour mean diastolic blood pressure
Mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg.
Measured: Baseline and annually for up to 5 years
24-hour mean heart rate
Mean heart rate measured by 24-hour ambulatory blood pressure monitoring. Units: beats per minute.
Measured: Baseline and annually for up to 5 years
Tremor frequency
Tremor frequency measured by tremor analysis as a quantitative indicator of tremor characteristics.
Measured: Baseline and annually for up to 5 years
Tremor amplitude
Tremor amplitude measured by tremor analysis as a quantitative indicator of tremor severity.
Measured: Baseline and annually for up to 5 years
Timed Up and Go test duration derived from wearable assessment
Timed Up and Go (TUG) test duration derived from wearable device-based assessment to evaluate mobility and functional movement performance.
Measured: Baseline and annually for up to 5 years
Machine vision-derived UPDRS Part III score
Unified Parkinson's Disease Rating Scale Part III motor score estimated using machine vision-based video assessment to quantify motor impairment.
Measured: Baseline and annually for up to 5 years
Structural MRI
Prespecified structural MRI-derived quantitative measure, such as regional brain volume or cortical thickness, assessed to characterize disease-related neuroanatomical changes.
Measured: Baseline and annually for up to 5 years
Resting-state functional MRI
Prespecified resting-state functional MRI quantitative measure, such as functional connectivity within a predefined brain network, assessed to characterize disease-related functional brain changes.
Measured: Baseline and annually for up to 5 years
Diffusion tensor imaging
Prespecified diffusion tensor imaging quantitative parameter, such as fractional anisotropy or mean diffusivity in a predefined tract or region of interest, assessed to characterize microstructural changes.
Measured: Baseline and annually for up to 5 years
Quantitative susceptibility mapping
Quantitative susceptibility mapping value measured in a prespecified brain region to assess iron-related imaging changes.
Measured: Baseline and annually for up to 5 years
Neuromelanin-sensitive MRI
Neuromelanin-sensitive magnetic resonance imaging signal intensity measured in a prespecified brain region to assess disease-related imaging changes.
Measured: Baseline and annually for up to 5 years
Tau PET/MR
Standardized uptake value ratio measured by tau PET/MR in a prespecified brain region using a prespecified tau tracer to assess tau-related signal.
Measured: Baseline and annually for up to 5 years
DAT PET/MR
Standardized uptake value ratio measured by dopamine transporter PET/MR in a prespecified brain region to assess dopaminergic terminal integrity.
Measured: Baseline and annually for up to 5 years
FDG PET/MR
Standardized uptake value ratio measured by FDG PET/MR in a prespecified brain region to assess regional glucose metabolism.
Measured: Baseline and annually for up to 5 years
Mean cerebral blood flow velocity during postural testing
Mean cerebral blood flow velocity measured during postural testing using continuous cerebral blood flow monitoring and transcranial Doppler ultrasonography to assess hemodynamic changes associated with postural challenge.
Measured: Baseline and annually for up to 5 years
Heart rate during postural testing with continuous hemodynamic monitoring
Heart rate measured during postural testing using continuous hemodynamic monitoring performed together with transcranial Doppler ultrasonography to assess autonomic and hemodynamic responses to postural challenge.
Measured: Baseline and annually for up to 5 years
Quantitative speech parameter from standardized speech assessment
Quantitative speech parameter measured during standardized speech assessment performed in a sound-controlled room to evaluate speech-related changes associated with Parkinsonism.
Measured: Baseline and annually for up to 5 years
Quantitative high-density electroencephalography parameter
Quantitative parameter derived from 64-channel high-density electroencephalography to assess neurophysiological changes associated with disease progression.
Measured: Baseline and annually for up to 5 years
Quantitative polysomnography parameter
Quantitative parameter derived from respiratory sleep monitoring to assess sleep-related physiological abnormalities during follow-up.
Measured: Baseline and annually for up to 5 years
Quantitative paired transcranial stimulation parameter
Quantitative parameter derived from paired transcranial stimulation to assess cortical excitability and related neurophysiological changes.
Measured: Baseline and annually for up to 5 years
Quantitative blood biomarker level
Quantitative level of a prespecified blood biomarker measured in biospecimens collected during follow-up to assess biological changes associated with disease progression.
Measured: Baseline and annually for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonismStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553845
- Sponsor's protocol ID
- Multimodal Parkinsonism Cohort
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Prospective Cohort Study of Parkinsonism
- ClinicalTrials.gov ID
- NCT07553845
- Acronym / sponsor ID
- Multimodal Parkinsonism Cohort
- Conditions
- Parkinsonism, REM Sleep Behavior Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 31 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- 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
- Meets the diagnostic criteria for Parkinsonism established by the International Parkinson and Movement Disorder Society
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Substantia nigra quantitative susceptibility mapping value
Time frame: Baseline and annually for up to 5 years
Quantitative susceptibility mapping (QSM) value measured in the substantia nigra by neuroimaging to assess disease-related imaging changes.
44 secondary outcomes
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
RBDSQ total score
Time frame: Baseline and annually for up to 5 years
PSQI total score
Time frame: Baseline and annually for up to 5 years
HAMD-17 total score
Time frame: Baseline and annually for up to 5 years
HAMA total score
Time frame: Baseline and annually for up to 5 years
MoCA score
Time frame: Baseline and annually for up to 5 years
MMSE score
Time frame: Baseline and annually for up to 5 years
FAB score
Time frame: Baseline and annually for up to 5 years
Oxyhemoglobin level during postural and motor testing
Time frame: Baseline and annually for up to 5 years
Deoxyhemoglobin level during postural and motor testing
Time frame: Baseline and annually for up to 5 years
Total hemoglobin level during postural and motor testing
Time frame: Baseline and annually for up to 5 years
24-hour mean systolic blood pressure
Time frame: Baseline and annually for up to 5 years
24-hour mean diastolic blood pressure
Time frame: Baseline and annually for up to 5 years
24-hour mean heart rate
Time frame: Baseline and annually for up to 5 years
Tremor frequency
Time frame: Baseline and annually for up to 5 years
Tremor amplitude
Time frame: Baseline and annually for up to 5 years
Timed Up and Go test duration derived from wearable assessment
Time frame: Baseline and annually for up to 5 years
Machine vision-derived UPDRS Part III score
Time frame: Baseline and annually for up to 5 years
Structural MRI
Time frame: Baseline and annually for up to 5 years
Resting-state functional MRI
Time frame: Baseline and annually for up to 5 years
Diffusion tensor imaging
Time frame: Baseline and annually for up to 5 years
Quantitative susceptibility mapping
Time frame: Baseline and annually for up to 5 years
Neuromelanin-sensitive MRI
Time frame: Baseline and annually for up to 5 years
Tau PET/MR
Time frame: Baseline and annually for up to 5 years
DAT PET/MR
Time frame: Baseline and annually for up to 5 years
FDG PET/MR
Time frame: Baseline and annually for up to 5 years
Mean cerebral blood flow velocity during postural testing
Time frame: Baseline and annually for up to 5 years
Heart rate during postural testing with continuous hemodynamic monitoring
Time frame: Baseline and annually for up to 5 years
Quantitative speech parameter from standardized speech assessment
Time frame: Baseline and annually for up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsonism and REM Sleep Behavior Disorder, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, Professor (+86-021-64370045, lj11128@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substantia nigra quantitative susceptibility mapping value (time frame: Baseline and annually for up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.