AI-Enhanced Optimization of Acute Levodopa Challenge Test

NCT ID: NCT06949865

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-28

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Parkinsonism Drug-induced Parkinsonism Corticobasal Degeneration (CBD) Parkinson Disease (PD) Dementia With Lewy Body Disease Progressive Supranuclear Palsy(PSP) Multiple System Atrophy (MSA)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

video recording

Intervention Type OTHER

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

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.

video recording

Intervention Type OTHER

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

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.

video recording

Intervention Type OTHER

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

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.

video recording

Intervention Type OTHER

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

Drug-induced parkinsonism (DIP) group

Parkinsonism.

video recording

Intervention Type OTHER

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

Corticobasal degeneration (CBD) group

Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration.

video recording

Intervention Type OTHER

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

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.

video recording

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

video recording

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruijin Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Xinjiang Medical University

UNKNOWN

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Tianjin Huanhu Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Wannan Medical College Yijishan Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tao Feng, MD

Role: CONTACT

86-13911125339

Lingyan Ma, MD

Role: CONTACT

86-13520873987

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Ling-yan Ma

Role: primary

86-13520873987

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HX-A-2024018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurofeedback Training for PD
NCT05987865 NOT_YET_RECRUITING NA