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

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Parkinson Disease
• Intervention / Treatment: Other: NeuraLight software-based platform

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eitan Raveh, PhD; Phone Number: +972-58-6277947; Email: eitan@neuralight.ai

Study Locations

• Israel
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD patients visiting clinic; 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; NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients
Experimental: Healthy subjects; 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; NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NeuraLight
• Investigators: Principal Investigator: Johnathan Reiner, MD, Sackler Faculty of Medicine, Tel Aviv University

Publications and helpful links

General Publications

• Anderson TJ, MacAskill MR. Eye movements in patients with neurodegenerative disorders. Nat Rev Neurol. 2013 Feb;9(2):74-85. doi: 10.1038/nrneurol.2012.273. Epub 2013 Jan 22.
• Waldthaler J, Tsitsi P, Svenningsson P. Vertical saccades and antisaccades: complementary markers for motor and cognitive impairment in Parkinson's disease. NPJ Parkinsons Dis. 2019 Jun 24;5:11. doi: 10.1038/s41531-019-0083-7. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NL/PD/2022-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not plan to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No