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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Parkinsonism; Multiple System Atrophy (MSA); Corticobasal Degeneration (CBD); Parkinson Disease (PD); Dementia With Lewy Body Disease; Progressive Supranuclear Palsy(PSP); Drug-induced Parkinsonism
• Intervention / Treatment: Other: video recording

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Tao Feng, MD; Phone Number: 86-13911125339; Email: bxbkyjs@sina.com
• Study Contact Backup: Name: Lingyan Ma, MD; Phone Number: 86-13520873987; Email: Jennifer_MLY@163.com

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital, Affiliated to Capital Medical University
    • Contact: Dr. Ling-yan Ma; Phone Number: 86-13520873987; Email: Jennifer_MLY@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In this study, participants are recruited from the multicenters across China. Participants are enrolled through outpatient assessment and screening.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's disease (PD) group: Patients with confirmed Parkinson's disease diagnosed based on the 2015 International Movement Disorder Society (MDS) Parkinson's Disease Diagnostic Criteria.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.
Multiple system atrophy (MSA) group; Patients with confirmed or probable MSA diagnosed based on the diagnostic criteria for MSA published by the International Movement Disorder Society (MDS) in 2022.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.
Progressive supranuclear palsy (PSP) group; Patients with confirmed or probable PSP diagnosed based on the diagnostic criteria of the 2017 International Movement Disorder Association PSP Collaborative Group.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.
Vascular parkinsonism (VP) group; 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.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.
Drug-induced parkinsonism (DIP) group; Parkinsonism.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.
Corticobasal degeneration (CBD) group; Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.
Dementia with Lewy Bodies (DLB) Group; Diagnosed as probable or possible DLB based on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLB diagnostic criteria.	Other: video recording; The patient's motor symptoms were recorded via video for assessment purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	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.	baseline
Diagnostic Odds Ratio	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.	baseline
Specificity	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).	baseline
Negative Predictive Value	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.	baseline
Sensitivity	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).	baseline
Positive Predictive Value	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Predictive Value	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.	baseline
root mean square error	Quantify the magnitude of the prediction error	baseline
Correlation Coefficient	Strength of the linear relationship between reflection and true results	baseline
Specificity	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.	baseline
Sensitivity	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.	baseline
Positive Predictive Value	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	baseline
Coefficient of Determination	The proportion of variation that reflects the interpretation of the results	baseline
Diagnostic Odds Ratio	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.	baseline
Accuracy	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	baseline
Intraclass Correlation Coefficient	Conduct differential diagnosis between Parkinson's disease and other Parkinsonian syndromes.Consistency and reliability of evaluation results	baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Eye Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Cranial Nerve Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Paralysis; Hypotension; Corticobasal Degeneration; Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive; Lewy Body Disease; Parkinsonian Disorders
• Other Study ID Numbers: HX-A-2024018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No