Clinical trial NCT06949865: AI-Enhanced Optimization of Acute Levodopa Challenge Test
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Nanjing Medical University
name: Second Affiliated Hospital of Soochow University
name: Beijing Hospital
name: Fujian Medical University Union Hospital
name: Guangdong Provincial People's Hospital
name: West China Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: China-Japan Union Hospital, Jilin University
name: Renmin Hospital of Wuhan University
name: First Affiliated Hospital of Chongqing Medical University
name: Second Affiliated Hospital of Nanchang University
name: Xijing Hospital
name: The Affiliated Hospital of Qingdao University
name: The Second Affiliated Hospital of Xinjiang Medical University
name: Shenzhen People's Hospital
name: Tianjin Medical University General Hospital
name: Qilu Hospital of Shandong University
name: The First People's Hospital of Yunnan
name: The First Hospital of Jilin University
name: Tianjin Huanhu Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Wannan Medical College Yijishan Hospital
name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2025-04-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy
timeFrame: baseline
measure: Diagnostic Odds Ratio
timeFrame: baseline
measure: Specificity
timeFrame: baseline
measure: Negative Predictive Value
timeFrame: baseline
measure: Sensitivity
timeFrame: baseline
measure: Positive Predictive Value
timeFrame: baseline
Secondary outcomes:
measure: Negative Predictive Value
timeFrame: baseline
measure: root mean square error
timeFrame: baseline
measure: Correlation Coefficient
timeFrame: baseline
measure: Specificity
timeFrame: baseline
measure: Sensitivity
timeFrame: baseline
measure: Positive Predictive Value
timeFrame: baseline
measure: Coefficient of Determination
timeFrame: baseline
measure: Diagnostic Odds Ratio
timeFrame: baseline
measure: Accuracy
timeFrame: baseline
measure: Intraclass Correlation Coefficient
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Affiliated to Capital Medical University
Study officials:
References: