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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Jun Liu, Professor contact

+86-021-64370045

lj11128@rjh.com.cn

China1 site, 1 recruiting
  • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

    Recruiting

Other trials in China

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.

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 groups in NCT07553845
Study groupRoleWhat they receive
ParkinsonismParticipants 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 DisorderParticipants 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 ControlsHealthy 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.

  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.

    Measured: Baseline and annually for up to 5 years

Secondary outcomes (44)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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. 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

  25. 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

  26. Tremor frequency

    Tremor frequency measured by tremor analysis as a quantitative indicator of tremor characteristics.

    Measured: Baseline and annually for up to 5 years

  27. Tremor amplitude

    Tremor amplitude measured by tremor analysis as a quantitative indicator of tremor severity.

    Measured: Baseline and annually for up to 5 years

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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.

  1. First posted28 Apr 2026
  2. Study start1 May 2024
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
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

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.

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