Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease

NeuraLight300 enrolled

Overview

This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinson's disease, who will be evaluated in several clinical centers with a clinical assessment and an oculometric examination during a time period with specific intervals. This study aims to evaluate the correlation between oculometric measures and clinical assessment over time, as well as the potential to detect early change in clinical status using an oculometric assessment.

This is an multicenter longitudinal study, in about 300 patients with idiopathic PD in several centers. The aim of this study is to evaluate the correlations between oculometric measures and clinical assessment, e.g. the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the MoCA score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. In addition, the investigators aim to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. All patients will be assessed over a period of 12 months (5 assessments, at 0, 3, 6, 9, 12 months). During this time period, every subject who consents will undergo a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye- tracking system (Tobii, CE-marked class B approved device) (approx. 30 minutes). The oculometric evaluation will occur for every patient every 3 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

300

Conditions

Parkinson Disease

Interventions

NeuraLightOTHER

NeuraLight software-based platform

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2) * Age between 40 and 85 years old * 0 to 5 years' time since diagnosis * Normal or corrected vision * Ability to follow instructions * Willing and able to sign an informed consent form * No anticipated changes in PD medications from baseline throughout the study duration based on clinical status during screening * If treated, stable on treatment for at least 3 months Exclusion Criteria: * Inability to sit for 40 minutes on a chair in a calm manner * Personal or 1st degree relative history of epilepsy * Additional neurological diseases * Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date) * Pregnancy or a potential pregnancy (self-declaration)

Locations (5)

Rush University

Chicago, Illinois, United States

AIBILI research center

Coimbra, Portugal

Instituto de Biomedicina de Sevilla (IBiS)

Seville, Spain

University Hospital Zürich

Zurich, Switzerland

The VCTC

Outcomes

Primary Outcomes

Change of saccadic latency over time as evaluated during visits

Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period

Time frame: 12 months

Change of anti-saccadic error rates over time as evaluated during visits

Difference between anti-saccadic error rates (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period

Time frame: 12 months

Change of smooth pursuit speed over time as evaluated during visits

Difference between smooth pursuit speed (ms)as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period

Time frame: 12 months

Correlation between MDS-UPDRS score and its parts with saccadic latency

The correlation between the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to MDS-UPDRS scores at visits

Time frame: 12 months

Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates

The correlation between Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with anti-saccadic error rates (%), measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the MDS-UPDRS scores at visits

Data from ClinicalTrials.gov

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Secondary Outcomes

Correlation between MoCA score and its parts with saccadic latency

The correlation between MoCA score and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation

Time frame: 12 months

Correlation between MoCA score and its parts with anti-saccadic error rates

The correlation between the Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with anti-saccadic error rates (%), measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Montreal Cognitive Assessment (MoCA) at visits

Time frame: 12 months

Correlation between MoCA score and its parts with smooth pursuit

The correlation between Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with smooth pursuit speed (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Montreal Cognitive Assessment (MoCA) at visits

Time frame: 12 months

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 Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating ScaleMDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with a relative root mean square error (RMSE) of \<0.1

Time frame: 12 months

Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MoCA 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 Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with a relative root mean square error (RMSE) of \<0.1

Time frame: 12 months