Machine Vision Based MDS-UPDRS III Machine Rating

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05906719
• Collaborator: Second Affiliated Hospital of Soochow University (Other), Beijing Hospital (Other), Beijing Tiantan Hospital (Other), Wuhan Union Hospital, China (Other), Fujian Medical University Union Hospital (Other), Guangdong Provincial People's Hospital (Other), West China Hospital (Other)
• Enrollment: 871
• Locations: 8
• Anticipated Duration (Months): 13
• Patients Per Site: 108.9
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

The Movement Disorders Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III (MDS-UPDRS III) is the primary assessment method for motor symptoms in Parkinson's disease patients. Currently, movement disorder specialists conduct semi-quantitative scoring, which entails limitations such as subjectivity, weak sensitivity, and a limited number of professional physicians. This study, based on machine vision, establishes gold standard labels according to expert scoring. By using machine learning, we develop a machine rating model and compare the model's performance with gold standard rating and general clinical rating to investigate the accuracy of machine vision-based MDS-UPDRS III machine rating.

Condition or Disease	Intervention/Treatment	Phase
Parkinsonian Disorders; Machine Learning	Other: video recording

Study Design

• Study Type: Observational
• Anticipated Enrollment: 871 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Machine Vision Based Machine Rating of MDS-UPDRS III
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Outcome Measures

Primary Outcome Measures

1. ACC0 of machine rating vs gold standard rating [1 day]

   The accuracy rate when machine rating equals gold standard rating.

2. ACC1 of machine rating vs gold standard rating [1 day]

   The accuracy rate when machine rating equals the range of gold standard rating plus or minus one.

3. Weighted kappa of machine rating vs gold standard rating [1 day]

   The weighted kappa when machine rating equals gold standard rating.

4. Lin's CCC of machine rating vs gold standard rating [1 day]

   The Lin's Concordance Correlation Coefficient when machine rating equals gold standard rating.

Secondary Outcome Measures

1. Accuracy rate of machine rating vs general clinical rating [1 day]

   Comparing the absolute residuals between machine rating and the gold standard rating with the absolute residuals between general clinical raitng and the gold standard rating.

2. Accuracy rate of machine facilitated rating vs general clinical rating [1 day]

   Comparing the absolute residuals between machine facilitated rating and the gold standard rating with the absolute residuals between general clinical raitng and the gold standard rating.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Meeting the diagnostic criteria for Parkinsonism established by the International Movement Disorder Society: having bradykinesia, and meeting at least one of the two criteria for resting tremor or muscle rigidity

• 20 to 80 years old

• Good compliance, voluntarily joining the study, and able to sign an informed consent form or have it signed by a legal representative

Exclusion Criteria:

• Significant cognitive impairment (MMSE ≤ 23)

• Unable to sign written informed consent or unable to complete the trial due to other reasons

• Other situations in which the researcher deems the participant unsuitable for this study

• Participation in other clinical trials

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100050
2	Beijing Hospital, Neurology Department	Beijing	Beijing	China	100730
3	Department of Neurology, Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001
4	Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong	China	510080
5	Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
6	Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215004
7	Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025
8	Department of Neurology, West China Hospital, Sichuan University	Chengdu	Sichuan	China	610044

Sponsors and Collaborators

• Ruijin Hospital
• Second Affiliated Hospital of Soochow University
• Beijing Hospital
• Beijing Tiantan Hospital
• Wuhan Union Hospital, China
• Fujian Medical University Union Hospital
• Guangdong Provincial People's Hospital
• West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT05906719
• Other Study ID Numbers: u3
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinsonian Disorders

Study Results

No Results Posted as of Jun 18, 2023