Oculomotor-Pupillary AI Biomarkers in Parkinson's

NCT07886450 | Not Yet Recruiting

• 1 other identifier: HSEARS20251219006
• Study Type: observational
• Target: 128
• Locations: 2 countries
• Sites: 2

Brief 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. 1.Complete standardized eye-tracking tasks to assess oculomotor and pupillary function using the study eye-tracking device.
2. 2.Undergo clinical assessments of motor function, cognitive function, and non-motor symptoms.
3. 3.For participants with PD, attend follow-up assessments over 12 months to evaluate changes in eye-tracking and clinical measures.

Conditions

PARKINSON DISEASE (Disorder)

Outcome Measures

Primary Outcomes (3)

• Differences in mean prosaccade gain between early-to-moderate PD patients and healthy controls.

  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.

  Baseline

• Differences in antisaccade directional error rate between early-to-moderate PD patients and healthy controls.

  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.

  Baseline

• Differences in mean prosaccade peak velocity between early-to-moderate PD patients and healthy controls.

  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.

  Baseline

Secondary Outcomes (3)

• Correlation Between Changes in Prosaccade Gain and MDS-UPDRS Part III Scores Over 12 Months

  Baseline to 12 months

• Correlation Between Changes in Antisaccade Directional Error Rate and MoCA Scores Over 12 Months

  Baseline to 12 months

• Area Under the Receiver Operating Characteristic Curve (AUC) for PD Classification

  Baseline

Study Arms (2)

Parkinson's Disease Group

Device: Edge-AI Eye-Tracking Assessment

Healthy Control Group

Device: Edge-AI Eye-Tracking Assessment

Interventions

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.

Healthy Control Group; Parkinson's Disease Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 45 years or older, including participants with early-to-moderate Parkinson's disease and age-comparable healthy controls. Participants with Parkinson's disease will be recruited from clinical populations and will undergo baseline eye-tracking and clinical assessments followed by longitudinal assessments over 12 months. Healthy controls without Parkinson's disease or other major neurological disorders will undergo baseline assessments for comparison with the Parkinson's disease group. All participants must be able to complete the required eye-tracking tasks and clinical assessments.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

First affiliated hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-09

Locations

HK (1); CN (1)