AI-Enhanced Optimization of Acute Levodopa Challenge Test

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Accuracy [Срок оценки: baseline]
• Diagnostic Odds Ratio [Срок оценки: baseline]
• Specificity [Срок оценки: baseline]
• Negative Predictive Value [Срок оценки: baseline]
• Sensitivity [Срок оценки: baseline]
• Positive Predictive Value [Срок оценки: baseline]

Вторичные конечные точки (10)

• Negative Predictive Value [Срок оценки: baseline]
• root mean square error [Срок оценки: baseline]
• Correlation Coefficient [Срок оценки: baseline]
• Specificity [Срок оценки: baseline]
• Sensitivity [Срок оценки: baseline]
• Positive Predictive Value [Срок оценки: baseline]
• Coefficient of Determination [Срок оценки: baseline]
• Diagnostic Odds Ratio [Срок оценки: baseline]
• Accuracy [Срок оценки: baseline]
• Intraclass Correlation Coefficient [Срок оценки: baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Cognitive dysfunction, unable to complete the study (MMSE < 23)
• Inability to tolerate levodopa shock test
• Patients with failure of important organs (heart, lung, liver, kidney, etc.), malignant tumors, unstable conditions and other serious internal diseases
• Those with serious behavioral problems or mental disorders
• Inability to sign informed consent
• Other conditions that are considered unsuitable by the investigator to participate in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Affiliated to Capital Medical University — Пекин

Идентификаторы

NCT: NCT06949865 · HX-A-2024018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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