Clinical trial NCT05906719: Machine Vision Based MDS-UPDRS III Machine Rating
Official title: Machine Vision Based Machine Rating of MDS-UPDRS III
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinsonian Disorders
Machine Learning
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Soochow University
name: Beijing Hospital
name: Beijing Tiantan Hospital
name: Wuhan Union Hospital, China
name: Fujian Medical University Union Hospital
name: Guangdong Provincial People's Hospital
name: West China Hospital
First posted: 2023-06-18
Enrollment: 871
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: ACC0 of machine rating vs gold standard rating
timeFrame: 1 day
measure: ACC1 of machine rating vs gold standard rating
timeFrame: 1 day
measure: Weighted kappa of machine rating vs gold standard rating
timeFrame: 1 day
measure: Lin's CCC of machine rating vs gold standard rating
timeFrame: 1 day
Secondary outcomes:
measure: Accuracy rate of machine rating vs general clinical rating
timeFrame: 1 day
measure: Accuracy rate of machine facilitated rating vs general clinical rating
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital, Neurology Department
state: Beijing
city: Fuzhou
country: China
facility: Department of Neurology, Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
city: Wuhan
country: China
facility: Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Suzhou
country: China
facility: Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Shanghai
country: China
facility: Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: Department of Neurology, West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: