Study on Artificial Intelligence-Based Facial and Speech-Related Patterns in Parkinson's Disease and Their Digital Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of the AI Model in Assessing [ Disease/Condition ] Severity
研究概览
简要总结
This research employs AI to analyze facial expressions and speech patterns, aiming to develop new digital tools for diagnosing and differentiating Parkinson's disease and similar disorders.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for Parkinson's Disease (PD) Group: (1) Diagnostic Criteria: Meet the diagnostic criteria for Parkinson's disease established by the Movement Disorder Society (MDS) in
- •(2) Age Range: 18-75 years old. (3) Disease Severity: Early-stage PD: Hoehn-Yahr score ≤ 2.5 points. Mid-to-late-stage PD: Hoehn-Yahr score 2.5-5 points. (4) Consent for Data Collection: Willing to undergo facial expression video and speech audio recording. (5) Informed Consent: Signed informed consent form.
- •Inclusion Criteria for Parkinson's Plus Syndromes (MSA-P, PSP) Group: (1) Age Range: 18-75 years old. (2) Diagnostic Criteria: MSA patients must meet the diagnostic criteria established by the [Chinese Expert Consensus on the Diagnosis of Multiple System Atrophy, 2017]. PSP patients must meet the diagnostic criteria established by the [Chinese Clinical Diagnostic Criteria for Progressive Supranuclear Palsy, 2016 Edition]. (3) Consent for Data Collection: Willing to undergo facial expression video and speech audio recording. (4) Informed Consent: Signed informed consent form.
排除标准
- •History of cerebrovascular disease, head trauma, hydrocephalus, brain tumors, or intracranial surgery.
- •Presence of metal implants, cardiac pacemakers, or other metallic foreign bodies (applies to PD patients).
- •Severe dyskinesia in PD patients that would compromise cooperation with video/audio recording.
- •Mini-Mental State Examination (MMSE) score ≤ 24 points.
研究组 & 干预措施
Parkinson's disease (PD) group
Participants meeting the 2015 MDS clinical diagnostic criteria for PD, aged 18-75. Includes both early (Hoehn-Yahr stage 1-2.5) and advanced (Hoehn-Yahr stage 2.5-5) patients. All participants provide informed consent for facial video and speech audio data collection. Exclusion criteria: history of stroke, head trauma, hydrocephalus, brain tumors, intracranial surgery, metal implants, pacemakers, severe dyskinesia, or MMSE score ≤ 24.
干预措施: video recording (Other)
Multiple System Atrophy (MSA) Group
Participants diagnosed with MSA-P according to the 2017 Chinese expert consensus diagnostic criteria, aged 18-75. For unified motor assessment, MDS-UPDRS I-IV and Hoehn-Yahr staging are used. All provide informed consent for data collection. Exclusion criteria: history of stroke, head trauma, hydrocephalus, brain tumors, intracranial surgery, metal implants, pacemakers, or MMSE score ≤ 24.
干预措施: video recording (Other)
Progressive Supranuclear Palsy (PSP) Group
Participants diagnosed with PSP according to the 2016 Chinese clinical diagnostic criteria, aged 18-75. For unified motor assessment, MDS-UPDRS I-IV and Hoehn-Yahr staging are used. All provide informed consent for data collection. Exclusion criteria: history of stroke, head trauma, hydrocephalus, brain tumors, intracranial surgery, metal implants, pacemakers, or MMSE score ≤ 24.
干预措施: video recording (Other)
Healthy Control Group
Age- and sex-matched healthy volunteers with no neurological diseases. MMSE score ≥ 24. All participants provide informed consent and undergo the same standardized facial video and speech audio recording tasks as the patient groups. Exclusion criteria: history of any neurological or psychiatric disorders.
干预措施: video recording (Other)
结局指标
主要结局
Diagnostic Accuracy of the AI Model in Assessing [ Disease/Condition ] Severity
时间窗: Baseline
The effectiveness of the model was demonstrated through a comparison between model-predicted scores and human expert ratings.
次要结局
未报告次要终点