AI-Enhanced Optimization of Acute Levodopa Challenge Test

Last updated: April 22, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple System Atrophy

Dyskinesias

Progressive Supranuclear Palsy

Treatment

video recording

Clinical Study ID

NCT06949865
HX-A-2024018
  • Ages 50-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Parkinson's disease (PD) group: 1. Patients with confirmed Parkinson's diseasediagnosed based on the 2015 International Movement Disorder Society (MDS)Parkinson's Disease Diagnostic Criteria; 2. Patients with early-stage PD meet theHoehn-Yahr score ≤ 2.5 points, and patients with intermediate and advanced PD meetthe Hoehn-Yahr score of 2.5-5 points; 3. Subjects are 50-75 years old (includingboundary values), gender is not limited; 4. Agree to undergo study-relatedexamination evaluation and sign informed consent.

  2. Multiple system atrophy (MSA) group : 1. Patients with confirmed or probable MSAdiagnosed based on the diagnostic criteria for MSA published by the InternationalMovement Disorder Society (MDS) in 2022 ;2. Subjects are 50-75 years old (includingboundary values), gender is not limited; 3. Agree to undergo study-relatedexamination evaluation and sign informed consent.

  3. Progressive supranuclear palsy (PSP) group: 1. Patients with confirmed or probablePSP diagnosed based on the diagnostic criteria of the 2017 International MovementDisorder Association PSP Collaborative Group; 2. Subjects are 50-75 years old (including boundary values), gender is not limited; 3. Agree to undergostudy-related examination evaluation and sign informed consent.

  4. Vascular parkinsonism (VP) group: 1. In line with the diagnostic recommendations ofvascular parkinsonism in accordance with the 2004 International Association forMovement Disorders and the 2017 Chinese expert consensus; 2. Subjects are 50-75years old (including boundary values), gender is not limited; 3. Agree to undergostudy-related examination evaluation and sign informed consent.

  5. Drug-induced parkinsonism (DIP) group: 1. Parkinsonism; 2. Drug history, theappearance of symptoms is related to specific drugs; 3. Symptoms are reversible, andthe 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 andsign informed consent.

  6. Corticobasal degeneration (CBD) group: 1. Diagnosis of probable or probable CBDbased 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 DLBbased on the 2017 international DLB diagnostic criteria and the 2021 Chinese DLBdiagnostic criteria. 2. Exhibits symptoms of Parkinsonism. 3. Subjects are aged 50-75 years (inclusive), with no gender restriction. 4. Agree to undergostudy-related assessments and evaluations and signs the informed consent form.

Exclusion

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 participatein this study.

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: video recording
Phase:
Study Start date:
May 28, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Tiantan Hospital, Affiliated to Capital Medical University

    Beijing, 100070
    China

    Active - Recruiting

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