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NCT Number: NCT07553845

A Multimodal Prospective Cohort Study of Parkinsonism

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.

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Key information

Age range

31 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 participant unsuitable for this study

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. UMSARS total score

    Time frame: Baseline and annually for up to 5 years

    Unified Multiple System Atrophy Rating Scale total score to assess motor and disease-related clinical severity. Higher scores indicate worse impairment.

  2. MDS-UPDRS total score

    Time frame: Baseline and annually for up to 5 years

    Movement Disorder Society-Unified Parkinson's Disease Rating Scale total score to assess Parkinsonian symptom severity. Higher scores indicate worse impairment.

  3. PSPRS total score

    Time frame: Baseline and annually for up to 5 years

    Progressive Supranuclear Palsy Rating Scale total score to assess disease severity in participants with PSP features. Higher scores indicate worse impairment.

  4. Tinetti gait and balance test score

    Time frame: Baseline and annually for up to 5 years

    Tinetti gait and balance test score to assess gait and balance performance. Lower scores indicate worse gait and balance function.

  5. Berg Balance Scale score

    Time frame: Baseline and annually for up to 5 years

    Berg Balance Scale score to assess balance function. Lower scores indicate worse balance.

  6. Hoehn and Yahr stage

    Time frame: Baseline and annually for up to 5 years

    Hoehn and Yahr stage to assess Parkinsonian disease stage. Higher stages indicate more advanced disease.

  7. NMSQ total score

    Time frame: Baseline and annually for up to 5 years

    Non-Motor Symptoms Questionnaire total score to assess non-motor symptom burden. Higher scores indicate greater non-motor symptom burden.

  8. SCOPA-AUT total score

    Time frame: Baseline and annually for up to 5 years

    Scales for Outcomes in Parkinson's Disease-Autonomic total score to assess autonomic dysfunction. Higher scores indicate worse autonomic symptoms.

  9. SS-16 olfactory score

    Time frame: Baseline and annually for up to 5 years

    Sniffin' Sticks 16-item olfactory identification score to assess olfactory function. Higher scores indicate better olfactory performance.

  10. Wexner constipation score

    Time frame: Baseline and annually for up to 5 years

    Wexner constipation score to assess constipation severity. Higher scores indicate worse constipation symptoms.

  11. PDQ-39 total score

    Time frame: Baseline and annually for up to 5 years

    Parkinson's Disease Questionnaire-39 total score to assess health-related quality of life. Higher scores indicate worse quality of life.

  12. EAT score

    Time frame: Baseline and annually for up to 5 years

    Eating Assessment Tool score to assess swallowing difficulty. Higher scores indicate worse swallowing symptoms.

  13. RBDSQ total score

    Time frame: Baseline and annually for up to 5 years

    Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire total score to assess REM sleep behavior disorder symptoms. Higher scores indicate worse symptom burden.

  14. PSQI total score

    Time frame: Baseline and annually for up to 5 years

    Pittsburgh Sleep Quality Index total score to assess sleep quality. Higher scores indicate worse sleep quality.

  15. HAMD-17 total score

    Time frame: Baseline and annually for up to 5 years

    17-item Hamilton Depression Rating Scale total score to assess depressive symptoms. Higher scores indicate worse depressive symptom severity.

  16. HAMA total score

    Time frame: Baseline and annually for up to 5 years

    Hamilton Anxiety Rating Scale total score to assess anxiety symptoms. Higher scores indicate worse anxiety symptom severity.

  17. MoCA score

    Time frame: Baseline and annually for up to 5 years

    Montreal Cognitive Assessment score to assess global cognitive function. Higher scores indicate better cognitive performance.

  18. MMSE score

    Time frame: Baseline and annually for up to 5 years

    Mini-Mental State Examination score to assess global cognitive function. Higher scores indicate better cognitive performance.

  19. FAB score

    Time frame: Baseline and annually for up to 5 years

    Frontal Assessment Battery score to assess frontal executive function. Higher scores indicate better executive performance.

  20. Oxyhemoglobin level during postural and motor testing

    Time frame: Baseline and annually for up to 5 years

    Oxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response.

  21. Deoxyhemoglobin level during postural and motor testing

    Time frame: Baseline and annually for up to 5 years

    Deoxyhemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response.

  22. Total hemoglobin level during postural and motor testing

    Time frame: Baseline and annually for up to 5 years

    Total hemoglobin level measured by near-infrared spectroscopy during postural and motor testing as a quantitative indicator of brain functional response.

  23. 24-hour mean systolic blood pressure

    Time frame: Baseline and annually for up to 5 years

    Mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg.

  24. 24-hour mean diastolic blood pressure

    Time frame: Baseline and annually for up to 5 years

    Mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring. Units: mmHg.

  25. 24-hour mean heart rate

    Time frame: Baseline and annually for up to 5 years

    Mean heart rate measured by 24-hour ambulatory blood pressure monitoring. Units: beats per minute.

  26. Tremor frequency

    Time frame: Baseline and annually for up to 5 years

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

  27. Tremor amplitude

    Time frame: Baseline and annually for up to 5 years

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

  28. Timed Up and Go test duration derived from wearable assessment

    Time frame: Baseline and annually for up to 5 years

    Timed Up and Go (TUG) test duration derived from wearable device-based assessment to evaluate mobility and functional movement performance.

  29. Machine vision-derived UPDRS Part III score

    Time frame: Baseline and annually for up to 5 years

    Unified Parkinson's Disease Rating Scale Part III motor score estimated using machine vision-based video assessment to quantify motor impairment.

  30. Structural MRI

    Time frame: Baseline and annually for up to 5 years

    Prespecified structural MRI-derived quantitative measure, such as regional brain volume or cortical thickness, assessed to characterize disease-related neuroanatomical changes.

  31. Resting-state functional MRI

    Time frame: Baseline and annually for up to 5 years

    Prespecified resting-state functional MRI quantitative measure, such as functional connectivity within a predefined brain network, assessed to characterize disease-related functional brain changes.

  32. Diffusion tensor imaging

    Time frame: Baseline and annually for up to 5 years

    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.

  33. Quantitative susceptibility mapping

    Time frame: Baseline and annually for up to 5 years

    Quantitative susceptibility mapping value measured in a prespecified brain region to assess iron-related imaging changes.

  34. Neuromelanin-sensitive MRI

    Time frame: Baseline and annually for up to 5 years

    Neuromelanin-sensitive magnetic resonance imaging signal intensity measured in a prespecified brain region to assess disease-related imaging changes.

  35. Tau PET/MR

    Time frame: Baseline and annually for up to 5 years

    Standardized uptake value ratio measured by tau PET/MR in a prespecified brain region using a prespecified tau tracer to assess tau-related signal.

  36. DAT PET/MR

    Time frame: Baseline and annually for up to 5 years

    Standardized uptake value ratio measured by dopamine transporter PET/MR in a prespecified brain region to assess dopaminergic terminal integrity.

  37. FDG PET/MR

    Time frame: Baseline and annually for up to 5 years

    Standardized uptake value ratio measured by FDG PET/MR in a prespecified brain region to assess regional glucose metabolism.

  38. Mean cerebral blood flow velocity during postural testing

    Time frame: Baseline and annually for up to 5 years

    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.

  39. Heart rate during postural testing with continuous hemodynamic monitoring

    Time frame: Baseline and annually for up to 5 years

    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.

  40. Quantitative speech parameter from standardized speech assessment

    Time frame: Baseline and annually for up to 5 years

    Quantitative speech parameter measured during standardized speech assessment performed in a sound-controlled room to evaluate speech-related changes associated with Parkinsonism.

  41. Quantitative high-density electroencephalography parameter

    Time frame: Baseline and annually for up to 5 years

    Quantitative parameter derived from 64-channel high-density electroencephalography to assess neurophysiological changes associated with disease progression.

  42. Quantitative polysomnography parameter

    Time frame: Baseline and annually for up to 5 years

    Quantitative parameter derived from respiratory sleep monitoring to assess sleep-related physiological abnormalities during follow-up.

  43. Quantitative paired transcranial stimulation parameter

    Time frame: Baseline and annually for up to 5 years

    Quantitative parameter derived from paired transcranial stimulation to assess cortical excitability and related neurophysiological changes.

  44. Quantitative blood biomarker level

    Time frame: Baseline and annually for up to 5 years

    Quantitative level of a prespecified blood biomarker measured in biospecimens collected during follow-up to assess biological changes associated with disease progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Liu, Professor

CONTACT

[email protected]

+86-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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