Oculomotor-Pupillary AI Biomarkers in Parkinson's

NCT07886450 — Not yet recruiting, 128 participants, The Hong Kong Polytechnic University

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Applied Database Study of Oculomotor-Pupillary Biomarkers Using Edge AI for Clinical Evaluation and Prediction in Parkinson's Disease

RegistryNCT07886450
StatusNot yet recruiting
Study typeObservational
Enrollment128 (Estimated)
SponsorThe Hong Kong Polytechnic University (Other)
ConditionsPARKINSON DISEASE (Disorder)
InterventionsEdge-AI Eye-Tracking Assessment (Device)
Datesstart 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
Locations2 sites in China, Hong Kong

Related Papers Related Patents Related Grants Related Experts
All trials for PARKINSON DISEASE (Disorder) All trials of Edge-AI Eye-Tracking Assessment

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Parkinson's Disease GroupDevice: Edge-AI Eye-Tracking Assessment
Healthy Control GroupDevice: Edge-AI Eye-Tracking Assessment
  • Edge-AI Eye-Tracking Assessment (Device): Participants will undergo standardized oculomotor and pupillary assessments using the study-developed edge-AI eye-tracking device. The assessment includes standardized visual tasks designed to evaluate fixation, saccadic eye movements, smooth pursuit, and pupillary responses. Eye movement and pupil data will be recorded and analyzed to identify oculomotor-pupillary biomarkers associated with Parkinson's disease. The device is used for research assessment only and does not alter participants' routine clinical treatment.

+Outcome measures

Primary outcomes

  • Differences in mean prosaccade gain between early-to-moderate PD patients and healthy controls. [Baseline]: Prosaccade gain is defined as the ratio of the primary saccade amplitude to the target displacement amplitude, measured using a head-mounted infrared eye-tracking device. The mean gain across valid trials will be calculated for each participant. Mean prosaccade gain will be compared between patients with early-to-moderate PD and healthy controls.
  • Differences in antisaccade directional error rate between early-to-moderate PD patients and healthy controls. [Baseline]: Antisaccade directional error rate is defined as the percentage of valid antisaccade trials in which the initial saccade is incorrectly directed toward the visual target rather than in the opposite direction, measured using a head-mounted infrared eye-tracking device. The error rate will be calculated for each participant as the number of directional error trials divided by the total number of valid antisaccade trials, multiplied by 100. Antisaccade directional error rate will be compared between patients with early-to-moderate PD and healthy controls.
  • Differences in mean prosaccade peak velocity between early-to-moderate PD patients and healthy controls. [Baseline]: Prosaccade peak velocity is defined as the maximum angular eye velocity during the primary prosaccade, measured in degrees per second (°/s) using a head-mounted infrared eye-tracking device. The mean peak velocity across valid trials will be calculated for each participant. Mean prosaccade peak velocity will be compared between patients with early-to-moderate PD and healthy controls.

Secondary outcomes

  • Correlation Between Changes in Prosaccade Gain and MDS-UPDRS Part III Scores Over 12 Months [Baseline to 12 months]: The correlation between changes in mean prosaccade gain and changes in motor symptom severity will be assessed in patients with PD over 12 months. Mean prosaccade gain will be measured using a head-mounted infrared eye-tracking device, while motor symptom severity will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). Changes in both measures will be calculated from baseline to 12 months, and their association will be quantified using a correlation coefficient (r).
  • Correlation Between Changes in Antisaccade Directional Error Rate and MoCA Scores Over 12 Months [Baseline to 12 months]: The correlation between changes in antisaccade directional error rate and changes in cognitive function will be assessed in patients with PD over 12 months. Antisaccade directional error rate is defined as the percentage of valid antisaccade trials in which the initial saccade is incorrectly directed toward the visual target, measured using a head-mounted infrared eye-tracking device. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Changes in both measures from baseline to 12 months will be calculated, and their association will be quantified using a correlation coefficient (r).
  • Area Under the Receiver Operating Characteristic Curve (AUC) for PD Classification [Baseline]: The diagnostic performance of an edge-AI model based on oculomotor-pupillary features measured using a head-mounted infrared eye-tracking device will be evaluated for distinguishing patients with PD from healthy controls. Model performance will be assessed using AUC, with values ranging from 0 to 1, where higher values indicate better discriminative performance.

+Eligibility

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.

+Locations (2)

FacilityCityCountryStatus
First affiliated hospital of Henan University of Chinese MedicineZhengzhou, HenanChina
Hong Kong Polytechnic UniversityHong Kong, Hong KongHong Kong