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Recruiting NCT06949865

AI-Enhanced Optimization of Acute Levodopa Challenge Test

— Observational Vascular Parkinsonism Drug-induced Parkinsonism Corticobasal Degeneration (CBD) Parkinson Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: video recording.
Who it may be relevant to
Registry conditions: Vascular Parkinsonism, Drug-induced Parkinsonism, Corticobasal Degeneration (CBD), Parkinson Disease (PD). Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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

Primary outcome measures

  • Accuracy [Time frame: baseline]
  • Diagnostic Odds Ratio [Time frame: baseline]
  • Specificity [Time frame: baseline]
  • Negative Predictive Value [Time frame: baseline]
  • Sensitivity [Time frame: baseline]
  • Positive Predictive Value [Time frame: baseline]
Secondary outcome measures (10)
  • Negative Predictive Value [Time frame: baseline]
  • root mean square error [Time frame: baseline]
  • Correlation Coefficient [Time frame: baseline]
  • Specificity [Time frame: baseline]
  • Sensitivity [Time frame: baseline]
  • Positive Predictive Value [Time frame: baseline]
  • Coefficient of Determination [Time frame: baseline]
  • Diagnostic Odds Ratio [Time frame: baseline]
  • Accuracy [Time frame: baseline]
  • Intraclass Correlation Coefficient [Time frame: baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT06949865 · HX-A-2024018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗