Applied Database Study of Oculomotor-Pupillary Biomarkers Using Edge AI for Clinical Evaluation and Prediction in Parkinson's Disease
| Registry | NCT07886450 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 128 (Estimated) |
| Sponsor | The Hong Kong Polytechnic University (Other) |
| Conditions | PARKINSON DISEASE (Disorder) |
| Interventions | Edge-AI Eye-Tracking Assessment (Device) |
| Dates | start 2026-11-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-10-21, last updated 2026-10-21 |
| Locations | 2 sites in China, Hong Kong |
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All trials for PARKINSON DISEASE (Disorder) All trials of Edge-AI Eye-Tracking Assessment
The goal of this prospective observational study is to investigate whether oculomotor-pupillary abnormalities detected using a novel edge-AI eye-tracking device can serve as objective and quantitative biomarkers for the early screening and clinical evaluation of Parkinson's disease (PD). The study will include individuals with early-to-moderate PD and healthy controls. The main question it aims to answer is:
Can oculomotor-pupillary abnormalities detected by a novel edge-AI eye-tracking device serve as objective and quantitative biomarkers for the early screening of Parkinson's disease?
Researchers will compare oculomotor-pupillary parameters between participants with PD and healthy controls and evaluate the ability of these parameters to distinguish PD from healthy controls. Participants with PD will also be followed for 12 months to assess longitudinal changes in eye-tracking measures and their associations with clinical changes.
Participants will:
1. Complete standardized eye-tracking tasks to assess oculomotor and pupillary function using the study eye-tracking device.
2. Undergo clinical assessments of motor function, cognitive function, and non-motor symptoms.
3. For participants with PD, attend follow-up assessments over 12 months to evaluate changes in eye-tracking and clinical measures.
The study will also evaluate the feasibility and clinical application of the independently developed edge-AI eye-tracking system and develop and validate lightweight real-time models for PD classification and prediction of disease progression.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Parkinson's Disease Group | Device: Edge-AI Eye-Tracking Assessment | ||
| Healthy Control Group | Device: Edge-AI Eye-Tracking Assessment |
Sex: All, ages: 45 Years to any, accepts healthy volunteers
Inclusion Criteria:
PD Group:
* Age ≥ 45 years old.
* Diagnosed with Parkinson's disease (PD) by a neurologist.
* Hoehn-Yahr (H\&Y) is staged as stage 1-3 (early-to-moderate PD).
* Newly diagnosed or drug-naive patients will be given priority, or patients who are already on medication but can stop taking it for at least 12 hours before testing ("Off" status).
* Participants who need to take medication must be accompanied by a caregiver, bring their own medication, and take it immediately after the assessment.
* Informed consent and voluntary participation in this study.
HC Group:
* Age ≥ 45 years old.
* No history of neurological or mental illness or prodromal symptoms.
* No family history of PD or prodromal symptoms of PD.
* Not taking any medications that may affect eye movement or nervous system function.
* Informed consent and voluntary participation in this study.
Exclusion Criteria:
* Habitual visual acuity less than 20/63 (LogMAR 0.5) in either eye.
* Combined with eye diseases that affect eye movement or vision, such as severe cataracts, glaucoma, macular degeneration, oculomotor paralysis, etc.
* Other neurological disorders, such as progressive supranuclear palsy, multiple system atrophy, Huntington's disease, cerebellar disorders, etc.
* Illiteracy or severe cognitive dysfunction.
* Severe mental diseases, such as major depressive disorder or schizophrenia.
* Unable to cooperate in completing the eye-tracking test.| Facility | City | Country | Status |
|---|---|---|---|
| First affiliated hospital of Henan University of Chinese Medicine | Zhengzhou, Henan | China | |
| Hong Kong Polytechnic University | Hong Kong, Hong Kong | Hong Kong |