Using AI to improve the levodopa challenge test for Parkinson's disease diagnosis
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
This study is testing a new way to diagnose Parkinson's disease using artificial intelligence and video recordings to see if it can improve the accuracy of the levodopa challenge test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06949865 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new quantitative method for diagnosing Parkinson's disease and other atypical parkinsonism by integrating motor paradigms with artificial intelligence and perception technologies. It aims to identify diagnostic cut-off values for various forms of parkinsonism and explore digital biomarkers for early and differential diagnosis. The approach combines traditional assessments with an acute levodopa challenge test and video recordings to enhance diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 50-75 with confirmed Parkinson's disease, multiple system atrophy, or progressive supranuclear palsy.
Not a fit: Patients outside the age range of 50-75 or those without a confirmed diagnosis of the specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and earlier diagnoses of Parkinson's disease and related conditions.
How similar studies have performed: Other studies have shown promise in using AI and digital biomarkers for diagnosing Parkinson's disease, indicating that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Beijing Tiantan Hospital, Affiliated to Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Tao Feng, MD
- Email: bxbkyjs@sina.com
- Phone: 86-13911125339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.