A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients

Study Overview
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Brief Summary
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This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's disease, examined routinely in the neurological outpatient clinic. This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated following a physician examination.The evaluations will include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In addition, 500 healthy subjects will be evaluated.

Detailed Description
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This is a prospective study in a cohort of patients with idiopathic PD who are visiting the Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who provide a signed Informed Consent. This study is designed to evaluate the correlation between oculometric measures and the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a NeuraLight session for oculometric evaluation along with eye-tracking recordings.

Official Title
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A Cross-Sectional Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS in Patients With Idiopathic Parkinson's Disease (PD) and Evaluation of Oculometric Measures in Healthy Participants

Conditions
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Idiopathic Parkinson Disease

Intervention / Treatment
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* Other: NeuraLight software-based platform


Participation Criteria
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Eligibility Criteria
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PD patients: Inclusion Criteria: Men and women with idiopathic PD (Hoehn & Yahr scale 1-5) Age between 18 and 85 years old Normal or corrected vision Ability to follow instructions Willing and able to sign an informed consent form Exclusion Criteria: Inability to sit for 20 minutes on a chair in a calm manner Personal or 1st degree relative history of epilepsy Additional neurological diseases Drug or alcohol abuse Healthy subjects: Inclusion Criteria: Age between 18 and 85 years old Normal or corrected vision Ability to follow instructions Willing and able to sign an informed consent form Exclusion Criteria Inability to sit for 20 minutes on a chair in a calm manner Personal or 1st degree relative history of epilepsy Neurological diseases Drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD patients visiting clinic<br>All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. | Other: NeuraLight software-based platform<br>* NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients<br>|
| Experimental: Healthy subjects<br>All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a visit unless authorized to be conducted remotely. | Other: NeuraLight software-based platform<br>* NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements | The correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements (R-Square>0.5, p<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at every visit | 12 months | 
| Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects | Capturing >50 different oculometric measures in >95% of a cohort of about 1000 patients | 12 months | 
| Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system | Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint | Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of MDS-UPDRS with a relative root mean square error (RMSE) of <0.1 | 12 months |