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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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;
- •Subjects are 50-75 years old (including boundary values), gender is not limited;
- •Agree to undergo study-related examination evaluation and sign informed consent.
- •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 ;
- •Subjects are 50-75 years old (including boundary values), gender is not limited;
- •Agree to undergo study-related examination evaluation and sign informed consent.
- •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;
- •Subjects are 50-75 years old (including boundary values), gender is not limited;
- •Agree to undergo study-related examination evaluation and sign informed consent.
- •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;
- •Subjects are 50-75 years old (including boundary values), gender is not limited;
- •Agree to undergo study-related examination evaluation and sign informed consent.
- •Drug-induced parkinsonism (DIP) group:
- •Parkinsonism;
- •Drug history, the appearance of symptoms is related to specific drugs;
- •Symptoms are reversible, and the symptoms are reduced or disappeared when the corresponding drugs are reduced;
- •Rule out other causes;
- •Subjects are 50-75 years old (including boundary values), gender is not limited;
- •Agree to undergo study-related examination evaluation and sign informed consent.
- •Corticobasal degeneration (CBD) group:
- •Diagnosis of probable or probable CBD based on the 2019 Chinese diagnostic criteria for corticobasal degeneration;
- •Subjects are 50-75 years old (including boundary values), gender is not limited;
- •Agree to undergo study-related examination evaluation and sign informed consent.
- •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.
- •Exhibits symptoms of Parkinsonism.
- •Subjects are aged 50-75 years (inclusive), with no gender restriction.
- •Agree to undergo study-related assessments and evaluations and signs the informed consent form.
排除标准
- •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.
结局指标
主要结局
Accuracy
时间窗: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The test correctly identified the total proportion of individuals with and without the disease.
Diagnostic Odds Ratio
时间窗: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The ratio of positive likelihood ratio to negative likelihood ratio reflects the diagnostic efficiency of the test.
Specificity
时间窗: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of healthy people without a certain disease correctly identified by a diagnostic test. High specificity means that the test rarely misdiagnoses healthy people as disease patients (i.e., low false positive rate).
Negative Predictive Value
时间窗: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Among all individuals who tested negative, the proportion who were truly free of the disease.
Sensitivity
时间窗: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.The proportion of patients with a disease correctly identified by a diagnostic test. High sensitivity means that the test rarely misses cases of disease (i.e., low false negative rate).
Positive Predictive Value
时间窗: baseline
Using quantitative assessment methods, conduct exploratory research on new methods for early diagnosis.Of all the individuals who tested positive, the proportion who actually had the disease.
次要结局
- Correlation Coefficient(baseline)
- Coefficient of Determination(baseline)
- Negative Predictive Value(baseline)
- root mean square error(baseline)
- Positive Predictive Value(baseline)
- Intraclass Correlation Coefficient(baseline)
- Specificity(baseline)
- Sensitivity(baseline)
- Accuracy(baseline)
- Diagnostic Odds Ratio(baseline)