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
Trial ID: NCT06949865
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-05-28
Completion date: 2026-12-31
Sponsor: Beijing Tiantan Hospital
Collaborators: Ruijin Hospital; Nanjing Medical University; Second Affiliated Hospital of Soochow University; Beijing Hospital; Fujian Medical University Union Hospital; Guangdong Provincial People's Hospital; West China Hospital; The First Affiliated Hospital of Dalian Medical University; China-Japan Union Hospital, Jilin University; Renmin Hospital of Wuhan University; First Affiliated Hospital of Chongqing Medical University; Second Affiliated Hospital of Nanchang University; Xijing Hospital; The Affiliated Hospital of Qingdao University; The Second Affiliated Hospital of Xinjiang Medical University; Shenzhen People's Hospital; Tianjin Medical University General Hospital; Qilu Hospital of Shandong University; The First People's Hospital of Yunnan; The First Hospital of Jilin University; Tianjin Huanhu Hospital; The First Affiliated Hospital of Anhui Medical University; Wannan Medical College Yijishan Hospital; The Affiliated Hospital of Xuzhou Medical University
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)
Interventions: video recording
Locations: Beijing Tiantan Hospital, Affiliated to Capital Medical University
Countries: China
Enrollment: 2000
Age range: 50 Years - 75 Years
Sex: ALL

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.

Outcomes:
Accuracy; Diagnostic Odds Ratio; Specificity; Negative Predictive Value; Sensitivity; Positive Predictive Value