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

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Healthy subjects:

Inclusion Criteria:

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Healthy subjects	NeuraLight software-based platform	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.
PD patients visiting clinic	NeuraLight software-based platform	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.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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