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NCT Number: NCT06949865

AI-Enhanced Optimization of Acute Levodopa Challenge Test

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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Key information

Conditions

Vascular Parkinsonism Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Corticobasal Degeneration Corticobasal Degeneration (CBD) Cranial Nerve Diseases Dementia With Lewy Body Disease Drug-induced Parkinsonism Eye Diseases Movement Disorders Multiple System Atrophy Multiple System Atrophy (MSA) Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinson Disease Parkinson Disease (PD) Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Primary Dysautonomias Progressive Supranuclear Palsy(PSP) Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Beijing, 100070, China

Location status: Recruiting

Location contact

Dr. Ling-yan Ma

CONTACT

[email protected]

86-13520873987

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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

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

Treatment and study plan

Video recording

Other

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

Primary outcomes

  1. Accuracy

    Time frame: 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.

  2. Diagnostic Odds Ratio

    Time frame: 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.

  3. Specificity

    Time frame: 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).

  4. Negative Predictive Value

    Time frame: 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.

  5. Sensitivity

    Time frame: 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).

  6. Positive Predictive Value

    Time frame: 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

  1. Negative Predictive Value

    Time frame: 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.

  2. root mean square error

    Time frame: baseline

    Quantify the magnitude of the prediction error

  3. Correlation Coefficient

    Time frame: baseline

    Strength of the linear relationship between reflection and true results

  4. Specificity

    Time frame: 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.

  5. Sensitivity

    Time frame: 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.

  6. Positive Predictive Value

    Time frame: 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

  7. Coefficient of Determination

    Time frame: baseline

    The proportion of variation that reflects the interpretation of the results

  8. Diagnostic Odds Ratio

    Time frame: 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.

  9. Accuracy

    Time frame: 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

  10. Intraclass Correlation Coefficient

    Time frame: baseline

    Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Consistency and reliability of evaluation results

Study contacts

Contact information is provided by the study sponsor or research team.

Lingyan Ma, MD

CONTACT

[email protected]

86-13520873987

Tao Feng, MD

CONTACT

[email protected]

86-13911125339

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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