- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381751
Artificial Intelligence-assisted MDS-UPDRS Assessment for Parkinson's Disease
Idiopathic Parkinson's disease (PD) is a neurodegenerative disease that progressively causes both motor and non-motor symptoms. As the second most common neurodegenerative disease and most common movement disorder, it affects over 8.5 million people worldwide and 13,000 people in Hong Kong. The most classical symptoms of PD are resting tremors, rigidity of the muscles, bradykinesia (slowing of movement), and gait difficulty. Other symptoms include sleep disorders, psychiatric symptoms, cognitive impairment, and autonomic dysfunction. Its pathophysiology is marked by the loss of dopaminergic neurons and the accumulation of aggregates called Lewy bodies.
The severity of PD-related motor symptoms is usually semi-quantitatively ("normal", "slight", "mild", "moderate", and "severe") evaluated by expert physicians and physiotherapists according to the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). However, the MDS-UPDRS III is semiquantitative and subjective, which might mask mild treatment effects or even provide false-positive results. Moreover, it takes significant time and effort for assessment with expected inter-observer variations.
To address these issues, various artificial intelligence (AI) technologies and telemedicine approaches have been investigated for patient evaluation. However, previous studies did not incorporate items assessing rigidity and postural stability, which require physical contact as per the MDS-UPDRS III instructions. Zhu et al. explored a motor symptom machine-rating system for the complete MDS-UPDRS III. Nevertheless, they employed a depth camera and conducted the tests within a strictly controlled ideal laboratory environment. For the widespread implementation of AI-assisted rating, the RGB camera is a more accessible alternative.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, prospective, observational study designed to develop and validate an AI-based MDS-UPDRS III assessment system using RGB camera data. Participants will be recruited from Queen Elizabeth Hospital's neurology outpatient clinic. Each subject will undergo standard MDS-UPDRS III evaluation by a certified clinician or physiotherapist, alongside synchronized RGB-D video recording. The videos will be processed through a deep learning pipeline trained to estimate the MDS-UPDRS III scores.
Blinded evaluations will be performed to compare AI-generated scores with ground truth clinician ratings. Statistical analysis will include inter-rater agreement metrics (e.g., ICC, Cohen's kappa), sensitivity to change, and subgroup analyses.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hiu Yi Wong, PhD
- Phone Number: +852-23587344
- Email: annawong@ust.hk
Study Contact Backup
- Name: Qian Zhang, PhD
- Phone Number: +852-23588766
- Email: qianzh@ust.hk
Study Locations
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-
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Hong Kong, China
- Hong Kong University of Science and Technology
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Principal Investigator:
- Qian Zhang, PhD
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Contact:
- Hiu Yi Wong, PhD
- Phone Number: +852-23587344
- Email: annawong@ust.hk
-
Contact:
- Qian Zhang, PhD
- Phone Number: +852-23588766
- Email: qianzh@ust.hk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of "Clinically Established PD" as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (MDS-PD criteria) [12]
- Able to provide informed consent and willing to participate in video-recorded MDS-UPDRS Part III assessments
- No significant visual, auditory, or musculoskeletal impairments that would interfere with video-based motor assessments
Exclusion Criteria:
- Unwillingness to be video recorded for study purposes
- History of neurodevelopmental disorder, neurodegenerative disease other than PD, CNS infection, neuroinflammatory disease (e.g. multiple sclerosis, CNS lupus), malignancy within the last 10 years, cerebrovascular accident, HIV infection, systemic autoimmune disease, alcohol dependence or other substance use
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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PD group
patients with Parkinson's disease
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clinical profile, MDS-UPDRS III, Video Recording
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AI-based motor assessment tool
Time Frame: Baseline to 3 years
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AI-based motor assessment tool utilizing RGB video for reliable and objective ratings of MDS-UPDRS III motor symptoms, including rigidity and postural stability.
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Baseline to 3 years
|
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Feasibility of implementing RGB camera-based assessments
Time Frame: 3 years
|
Feasibility of implementing RGB camera-based assessments in routine clinical settings will be assessed by the proportion of assessments in which the AI system is able to generate an estimated MDS-UPDRS Part III total score based on RGB video that can be directly compared with clinician-rated MDS-UPDRS Part III scores.
Patients perform standardized motor tasks under physician guidance while RGB video is recorded using a smartphone.
Clinician-rated MDS-UPDRS Part III scores are used as the ground truth.
Feasibility outcomes will be reported as the percentage (%) of assessments with valid AI-generated scores over a 3-year study period.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System's effectiveness
Time Frame: 3 years
|
System effectiveness in estimating motor symptom severity will be measured by the agreement between AI-predicted and clinician-rated MDS-UPDRS Part III scores.
RGB video is recorded using a smartphone while patients perform standardized motor tasks under physician supervision.
Clinician-rated MDS-UPDRS Part III scores are used as the ground truth.
The AI system generates predicted MDS-UPDRS Part III total scores (range 0-108, with higher scores indicating more severe motor impairment).
System effectiveness will be evaluated using F1 score, correlation between predicted and clinician-rated scores, and sensitivity and specificity for the detection of clinically significant motor impairment based on predefined score thresholds.
Effectiveness outcomes will be reported over a 3-year study period.
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3 years
|
|
Patient and clinician satisfaction
Time Frame: baseline to 3 years
|
Patient satisfaction with the AI-assisted assessment system will be assessed using a study-specific questionnaire administered after completion of RGB camera-based motor tasks.
Questionnaire items are rated on a Likert scale, with higher scores indicating greater satisfaction.
Clinician evaluation of the AI-assisted assessment system will be assessed using a study-specific questionnaire evaluating perceived credibility, perceived effectiveness, and overall satisfaction with the system.
Questionnaire items are rated on a Likert scale, with higher scores indicating more positive evaluations.
Patient and clinician evaluation outcomes will be reported as mean ± standard deviation over the study period.
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baseline to 3 years
|
|
System's performance
Time Frame: baseline to 3 years
|
System performance will be measured by the accuracy and mean absolute error (MAE) of AI-predicted MDS-UPDRS Part III total scores compared with clinician-rated scores.
Patients perform standardized motor tasks under physician supervision while RGB video is recorded using a smartphone.
Clinician-rated MDS-UPDRS Part III scores are used as the ground truth.
System performance is defined as the accuracy and MAE of AI predictions.
Performance outcomes will be summarized over the study period.
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baseline to 3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Qian Zhang, PhD, Hong Kong University of Science and Technology
Publications and helpful links
General Publications
- Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
- Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Ou Z, Pan J, Tang S, Duan D, Yu D, Nong H, Wang Z. Global Trends in the Incidence, Prevalence, and Years Lived With Disability of Parkinson's Disease in 204 Countries/Territories From 1990 to 2019. Front Public Health. 2021 Dec 7;9:776847. doi: 10.3389/fpubh.2021.776847. eCollection 2021.
- Aarsland D, Batzu L, Halliday GM, Geurtsen GJ, Ballard C, Ray Chaudhuri K, Weintraub D. Parkinson disease-associated cognitive impairment. Nat Rev Dis Primers. 2021 Jul 1;7(1):47. doi: 10.1038/s41572-021-00280-3.
- Zhu X, Chen Z, Ling Y, Luo N, Yin Q, Zhang Y, Zhao A, Ye G, Zhou H, Pan J, Zhou L, Cao L, Huang P, Zhang P, Chen C, Shi W, Lin S, Zhuang H, Zhao J, Ren K, Tan Y, Liu J. Motor symptom machine rating system for complete MDS-UPDRS III in Parkinson's disease: A proof-of-concept pilot study. Chin Med J (Engl). 2024 Jul 5;137(13):1632-1634. doi: 10.1097/CM9.0000000000003044. Epub 2024 Mar 19. No abstract available.
- Boroojerdi B, Ghaffari R, Mahadevan N, Markowitz M, Melton K, Morey B, Otoul C, Patel S, Phillips J, Sen-Gupta E, Stumpp O, Tatla D, Terricabras D, Claes K, Wright JA Jr, Sheth N. Clinical feasibility of a wearable, conformable sensor patch to monitor motor symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2019 Apr;61:70-76. doi: 10.1016/j.parkreldis.2018.11.024. Epub 2018 Nov 27.
- Lu M, Poston K, Pfefferbaum A, Sullivan EV, Fei-Fei L, Pohl KM, Niebles JC, Adeli E. Vision-based Estimation of MDS-UPDRS Gait Scores for Assessing Parkinson's Disease Motor Severity. Med Image Comput Comput Assist Interv. 2020 Oct;12263:637-647. doi: 10.1007/978-3-030-59716-0_61. Epub 2020 Sep 29.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Health Services Administration
- Quality of Health Care
- Outcome Assessment, Health Care
- Outcome and Process Assessment, Health Care
- Watchful Waiting
Other Study ID Numbers
- HREP-2025-0238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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