- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05906719
Machine Vision Based MDS-UPDRS III Machine Rating
June 7, 2023 updated by: Ruijin Hospital
Machine Vision Based Machine Rating of MDS-UPDRS III
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
871
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lun Liu, MD,PhD
- Phone Number: 021-86-64370045
- Email: jly0520@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Not yet recruiting
- Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Tao Feng, MD
- Phone Number: 86-010-59976611
- Email: happyfym@gmail.com
-
Beijing, Beijing, China, 100730
- Not yet recruiting
- Beijing Hospital, Neurology Department
-
Contact:
- Wen Su, MD
- Phone Number: 86-010-85132266
- Email: suwendy@126.com
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Not yet recruiting
- Department of Neurology, Fujian Medical University Union Hospital
-
Contact:
- Qinyong Ye, MD
- Phone Number: 86-0591-83357896
- Email: unionqyye@163.com
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Not yet recruiting
- Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
-
Contact:
- Lijuan Wang, MD
- Phone Number: 86-020-83827812
- Email: wljgd68@163.com
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Not yet recruiting
- Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Tao Wang, MD
- Phone Number: 86-027-85726114
- Email: wangtaowh@hust.edu.cn
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215004
- Not yet recruiting
- Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University
-
Contact:
- Chunfeng Liu, MD
- Phone Number: 86-0512-68282030
- Email: liuchunfeng@suda.edu.cn
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
-
Contact:
- Jun Liu, MD,PhD
- Phone Number: 86-021-64370045
- Email: jly0520@hotmail.com
-
-
Sichuan
-
Chengdu, Sichuan, China, 610044
- Not yet recruiting
- Department of Neurology, West China Hospital, Sichuan University
-
Contact:
- Huifang Shang, MD
- Phone Number: 86-028-85422114
- Email: hfshang2002@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
In this study, participants are mainly recruited from the Department of Neurology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, as well as from movement disorder clinics at 7 other centers.
Participants are enrolled through outpatient assessment and screening.
Two specialists in movement disorders independently diagnosed participants as having "Parkinsonism".
In cases where there is a diagnostic disagreement, the Movement Disorder Specialist Group at the Department of Neurology, Ruijin Hospital collectively discusses and makes the decision.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ACC0 of machine rating vs gold standard rating
Time Frame: 1 day
|
The accuracy rate when machine rating equals gold standard rating.
|
1 day
|
|
ACC1 of machine rating vs gold standard rating
Time Frame: 1 day
|
The accuracy rate when machine rating equals the range of gold standard rating plus or minus one.
|
1 day
|
|
Weighted kappa of machine rating vs gold standard rating
Time Frame: 1 day
|
The weighted kappa when machine rating equals gold standard rating.
|
1 day
|
|
Lin's CCC of machine rating vs gold standard rating
Time Frame: 1 day
|
The Lin's Concordance Correlation Coefficient when machine rating equals gold standard rating.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy rate of machine rating vs general clinical rating
Time Frame: 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.
|
1 day
|
|
Accuracy rate of machine facilitated rating vs general clinical rating
Time Frame: 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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
June 7, 2023
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Estimated)
June 16, 2023
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- u3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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