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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital, Affiliated to Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Tao Feng, MD
bxbkyjs@sina.com
86-13911125339
Backup
Lingyan Ma, MD
Jennifer_MLY@163.com
86-13520873987
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2000
Treatments
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.
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.
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.
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.
Drug-induced parkinsonism (DIP) group
Parkinsonism.
Corticobasal degeneration (CBD) group
Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration.
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.
Sponsors
Collaborators: Shenzhen People's Hospital, The Affiliated Hospital of Xuzhou Medical University, Ruijin Hospital, The First Affiliated Hospital of Dalian Medical University, West China Hospital, China-Japan Union Hospital, Jilin University, Xijing Hospital, Beijing Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Xinjiang Medical University, Second Affiliated Hospital of Nanchang University, Nanjing Medical University, Tianjin Huanhu Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital of Anhui Medical University, Tianjin Medical University General Hospital, Wannan Medical College Yijishan Hospital, The First People's Hospital of Yunnan, Guangdong Provincial People's Hospital, The First Hospital of Jilin University, Second Affiliated Hospital of Soochow University, Renmin Hospital of Wuhan University
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov