A Longitudinal Evaluation of Oculometric Measures and Clinical Assessment Over Time in PD Patients

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: NeuraLight

• Registration Number: NCT05795023
• Lead Sponsor: NeuraLight

Brief Summary

This is a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated 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.

Detailed Description

This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 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 during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). 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 Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-03
• Study Start: 2023-05-08
• Status Verified: 2024-10
• Primary Completion: 2024-10-28
• Study Completion: 2024-10-28
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men and women with idiopathic PD (Hoehn & Yahr scale 1-3)
• Age between 18 and 85 years old
• Normal or corrected vision
• Ability to follow instructions
• Willing and able to sign an informed consent form

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Exclusion Criteria

• Inability to sit for 30 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD patients	NeuraLight	Men and women with idiopathic PD (Hoehn \& Yahr scale 1-3) aged 18-85 years

Primary Outcome Measures

Name	Time	Method
Change of anti-saccadic error rates over time as evaluated during visits	12 months	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
Correlation between MDS-UPDRS score and its parts with smooth pursuit	12 months	The correlation between MDS-UPDRS score and its parts 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Change of saccadic latency over time as evaluated during visits	12 months	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
Change of smooth pursuit speed over time as evaluated during visits	12 months	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
Correlation between MDS-UPDRS score and its parts with saccadic latency	12 months	The correlation between MDS-UPDRS score 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 the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates	12 months	The correlation between MDS-UPDRS score 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits

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

Trial Locations

Locations (1)

Movement Disorders Unit, Sourasky Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel