AI-Enhanced Optimization of Acute Levodopa Challenge Test

NCT06949865 | Recruiting DMC

• 1 other identifier: HX-A-2024018
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Negative Predictive Value

  baseline

• root mean square error

  baseline

• Correlation Coefficient

  baseline

• Specificity

  baseline

• Sensitivity

  baseline

Study Arms (7)

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

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

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

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

Drug-induced parkinsonism (DIP) group

Parkinsonism.

Other: video recording

Corticobasal degeneration (CBD) group

Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration.

Other: video recording

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

Interventions

video recording OTHER

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

Corticobasal degeneration (CBD) group; Dementia with Lewy Bodies (DLB) Group; Drug-induced parkinsonism (DIP) group; Multiple system atrophy (MSA) group; Parkinson's disease (PD) group:; Progressive supranuclear palsy (PSP) group; Vascular parkinsonism (VP) group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Corticobasal Degeneration; Parkinson Disease; Supranuclear Palsy, Progressive; Multiple System Atrophy

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Central Study Contacts

Tao Feng, MD

CONTACT

86-13911125339; bxbkyjs@sina.com

Lingyan Ma, MD

CONTACT

86-13520873987; Jennifer_MLY@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: May 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)