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

Sponsor

NeuraLight (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05437003

Collaborator

(none)

1,000

Enrollment

Location

Arms

16.4

Anticipated Duration (Months)

61.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson Disease	Other: NeuraLight software-based platform	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2022

Anticipated Primary Completion Date :

Jul 20, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements [12 months]
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
Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects [12 months]
Capturing >50 different oculometric measures in >95% of a cohort of about 1000 patients
Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system [12 months]
Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1

Secondary Outcome Measures

Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tikva		Israel	4941492

Sponsors and Collaborators

NeuraLight

Investigators

Principal Investigator: Johnathan Reiner, MD, Sackler Faculty of Medicine, Tel Aviv University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

NeuraLight

ClinicalTrials.gov Identifier:

NCT05437003

Other Study ID Numbers:

NL/PD/2022-1

First Posted:

Jun 29, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Aug 16, 2022