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AI-Enhanced Optimization of Acute Levodopa Challenge Test

Clinical Research on Optimization of Acute Levodopa Challenge Test and Exploration of New Motor Paradigm Based on the Integration of Perception Technology and Artificial Intelligence

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06949865
Enrollment
2000
Registered
2025-04-29
Start date
2024-05-28
Completion date
2026-12-31
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corticobasal Degeneration (CBD), Dementia With Lewy Body Disease, Drug-induced Parkinsonism, Multiple System Atrophy (MSA), Parkinson Disease (PD), Progressive Supranuclear Palsy(PSP), Vascular Parkinsonism

Brief summary

A quantitative evaluation method was developed for Parkinson's disease and other atypical parkinonism by integrating an innovative motor paradigm with perception technologies and artificial intelligence. Combined with traditional motor paradigms and the acute levodopa challenge test, this study aims to identify diagnostic cut-off values for PD and other atypical parkinonism, explore digital biomarkers for early and differential diagnosis, and establish a corresponding diagnostic model.

Interventions

The patient's motor symptoms were recorded via video for assessment purposes.

Sponsors

Ruijin Hospital
CollaboratorOTHER
Nanjing Medical University
CollaboratorOTHER
Second Affiliated Hospital of Soochow University
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
Fujian Medical University Union Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
The First Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
China-Japan Union Hospital, Jilin University
CollaboratorOTHER
Renmin Hospital of Wuhan University
CollaboratorOTHER
First Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Second Affiliated Hospital of Nanchang University
CollaboratorOTHER
Xijing Hospital
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
The Second Affiliated Hospital of Xinjiang Medical University
CollaboratorUNKNOWN
Shenzhen People's Hospital
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
The First People's Hospital of Yunnan
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
Tianjin Huanhu Hospital
CollaboratorOTHER
The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
Wannan Medical College Yijishan Hospital
CollaboratorOTHER
The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Parkinson's disease (PD) group: 1. Patients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria; 2. Patients with early-stage PD meet the Hoehn-Yahr score ≤ 2.5 points, and patients with intermediate and advanced PD meet the Hoehn-Yahr score of 2.5-5 points; 3. Subjects are 50-75 years old (including boundary values), gender is not limited; 4. Agree to undergo study-related examination evaluation and sign informed consent. 2. Multiple system atrophy (MSA) group : 1. Patients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022 ;2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent. 3. Progressive supranuclear palsy (PSP) group: 1. Patients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent. 4. Vascular parkinsonism (VP) group: 1. In line with the diagnostic recommendations of vascular parkinsonism in accordance with the 2004 International Association for Movement Disorders and the 2017 Chinese expert consensus; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent. 5. Drug-induced parkinsonism (DIP) group: 1. Parkinsonism; 2. Drug history, the appearance of symptoms is related to specific drugs; 3. Symptoms are reversible, and the symptoms are reduced or disappeared when the corresponding drugs are reduced; 4. Rule out other causes; 5. Subjects are 50-75 years old (including boundary values), gender is not limited; 6. Agree to undergo study-related examination evaluation and sign informed consent. 6. Corticobasal degeneration (CBD) group: 1. Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergo study-related examination evaluation and sign informed consent. 7. Dementia with Lewy Bodies (DLB) Group: 1. Diagnosed as probable or possible DLB based on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLB diagnostic criteria. 2. Exhibits symptoms of Parkinsonism. 3. Subjects are aged 50-75 years (inclusive), with no gender restriction. 4. Agree to undergo study-related assessments and evaluations and signs the informed consent form.

Exclusion criteria

1. Cognitive dysfunction, unable to complete the study (MMSE \< 23) 2. Inability to tolerate levodopa shock test 3. Patients with failure of important organs (heart, lung, liver, kidney, etc.), malignant tumors, unstable conditions and other serious internal diseases 4. Those with serious behavioral problems or mental disorders 5. Inability to sign informed consent 6. Other conditions that are considered unsuitable by the investigator to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
AccuracybaselineUsing quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The test correctly identified the total proportion of individuals with and without the disease.
Diagnostic Odds RatiobaselineUsing quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The ratio of positive likelihood ratio to negative likelihood ratio reflects the diagnostic efficiency of the test.
SpecificitybaselineUsing quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of healthy people without a certain disease correctly identified by a diagnostic test. High specificity means that the test rarely misdiagnoses healthy people as disease patients (i.e., low false positive rate).
Negative Predictive ValuebaselineUsing quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Among all individuals who tested negative, the proportion who were truly free of the disease.
SensitivitybaselineUsing quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of patients with a disease correctly identified by a diagnostic test. High sensitivity means that the test rarely misses cases of disease (i.e., low false negative rate).
Positive Predictive ValuebaselineUsing quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Of all the individuals who tested positive, the proportion who actually had the disease.

Secondary

MeasureTime frameDescription
Coefficient of DeterminationbaselineThe proportion of variation that reflects the interpretation of the results
Diagnostic Odds RatiobaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.The ratio of positive likelihood ratio to negative likelihood ratio reflects the diagnostic efficiency of the test.
Negative Predictive ValuebaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Among all individuals who test negative, the proportion who are truly free of the disease.
Intraclass Correlation CoefficientbaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Consistency and reliability of evaluation results
AccuracybaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.The total proportion of individuals with and without the disease correctly identified by the test
root mean square errorbaselineQuantify the magnitude of the prediction error
Correlation CoefficientbaselineStrength of the linear relationship between reflection and true results
SpecificitybaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Diagnostic tests correctly identify the proportion of healthy people who do not have a disease.
SensitivitybaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Refers to the proportion of patients with a disease that a diagnostic test correctly identifies.
Positive Predictive ValuebaselineConduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Of all the individuals who tested positive, the proportion who actually had the disease

Countries

China

Contacts

Primary ContactTao Feng, MD
bxbkyjs@sina.com86-13911125339
Backup ContactLingyan Ma, MD
Jennifer_MLY@163.com86-13520873987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026