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AI-Enhanced Optimization of Acute Levodopa Challenge Test

NCT06949865 — Recruiting, 2000 participants, Beijing Tiantan Hospital

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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

RegistryNCT06949865
StatusRecruiting
Study typeObservational
Enrollment2000 (Estimated)
SponsorBeijing Tiantan Hospital (Other); collaborators: Ruijin Hospital, Nanjing Medical University, Second Affiliated Hospital of Soochow University, Beijing Hospital, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, West China Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, Renmin Hospital of Wuhan University, First Affiliated Hospital of Chongqing Medical University, Second Affiliated Hospital of Nanchang University, Xijing Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Xinjiang Medical University, Shenzhen People's Hospital, Tianjin Medical University General Hospital, Qilu Hospital of Shandong University, The First People's Hospital of Yunnan, The First Hospital of Jilin University, Tianjin Huanhu Hospital, The First Affiliated Hospital of Anhui Medical University, Wannan Medical College Yijishan Hospital, The Affiliated Hospital of Xuzhou Medical University
ConditionsVascular Parkinsonism, Drug-induced Parkinsonism, Corticobasal Degeneration (CBD), Parkinson Disease (PD), Dementia With Lewy Body Disease, Progressive Supranuclear Palsy(PSP), Multiple System Atrophy (MSA)
Interventionsvideo recording (Other)
Datesstart 2024-05-28, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-04-29, last updated 2025-04-29
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Parkinson's disease (PD) group:Other: video recordingPatients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria.
Multiple system atrophy (MSA) groupOther: video recordingPatients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022.
Progressive supranuclear palsy (PSP) groupOther: video recordingPatients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group.
Vascular parkinsonism (VP) groupOther: video recordingIn line with the diagnostic recommendations of vascular parkinsonism in accordance with the 2004 International Association for Movement Disorders and the 2017 Chinese expert consensus.
Drug-induced parkinsonism (DIP) groupOther: video recordingParkinsonism.
Corticobasal degeneration (CBD) groupOther: video recordingDiagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration.
Dementia with Lewy Bodies (DLB) GroupOther: video recordingDiagnosed as probable or possible DLB based on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLB diagnostic criteria.
  • video recording (Other): The patient's motor symptoms were recorded via video for assessment purposes.

+Outcome measures

Primary outcomes

  • Accuracy [baseline]: Using 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 Ratio [baseline]: Using 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.
  • Specificity [baseline]: Using 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 Value [baseline]: Using 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.
  • Sensitivity [baseline]: Using 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 Value [baseline]: Using 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 outcomes

  • Negative Predictive Value [baseline]: Conduct 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.
  • root mean square error [baseline]: Quantify the magnitude of the prediction error
  • Correlation Coefficient [baseline]: Strength of the linear relationship between reflection and true results
  • Specificity [baseline]: Conduct 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.
  • Sensitivity [baseline]: Conduct 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 Value [baseline]: Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Of all the individuals who tested positive, the proportion who actually had the disease
  • Coefficient of Determination [baseline]: The proportion of variation that reflects the interpretation of the results
  • Diagnostic Odds Ratio [baseline]: Conduct 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.
  • Accuracy [baseline]: Conduct 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
  • Intraclass Correlation Coefficient [baseline]: Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Consistency and reliability of evaluation results

+Eligibility

Sex: All, ages: 50 Years to 75 Years

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.

+Locations (1)

FacilityCityCountryStatus
Beijing Tiantan Hospital, Affiliated to Capital Medical UniversityBeijingChinaRecruiting

My Notes