NCT07381751

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Feb 2029

First Submitted

Initial submission to the registry

January 13, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 13, 2026

Last Update Submit

January 26, 2026

Conditions

Parkinson Disease

Keywords

artificial intelligence, MDS-UPDRS, Parkinson's disease

Outcome Measures

Primary Outcomes (2)

  • AI-based motor assessment tool

    AI-based motor assessment tool utilizing RGB video for reliable and objective ratings of MDS-UPDRS III motor symptoms, including rigidity and postural stability.

    Baseline to 3 years

  • Feasibility of implementing RGB camera-based assessments

    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 Outcomes (3)

  • System's effectiveness

    3 years

  • Patient and clinician satisfaction

    baseline to 3 years

  • System's performance

    baseline to 3 years

Study Arms (1)

PD group

patients with Parkinson's disease

Other: Observational

Interventions

ObservationalOTHER

clinical profile, MDS-UPDRS III, Video Recording

PD group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with Parkinson's disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong University of Science and Technology

Hong Kong, China

Location

Related Publications (7)

  • 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.

    PMID: 26474316BACKGROUND

  • 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.

    PMID: 38501363BACKGROUND

  • 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.

    PMID: 30635244BACKGROUND

  • 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.

    PMID: 33103164BACKGROUND

  • 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.

    PMID: 19025984BACKGROUND

  • 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.

    PMID: 34950630BACKGROUND

  • 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.

    PMID: 34210995BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Qian Zhang, PhD

    Hong Kong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Zhang, PhD

CONTACT

+852-23588766qianzh@ust.hk

Hiu Yi Wong, PhD

CONTACT

+852-23587344annawong@ust.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)