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

Parkinson Disease Clinical Trial

Official title:

A Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS Over Time in a Cohort of Patients With Idiopathic Parkinson's Disease (PD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795023
• Other study ID #: NL/PD/2022-3
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: NeuraLight
• Contact: Adi Ezra, Msc
• Phone: +972-6974909
• Email: adil[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• NeuraLight
NeuraLight software-based platform

Locations

Country	Name	City	State
Israel	Movement Disorders Unit, Sourasky Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
NeuraLight

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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	12 months
Primary	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	12 months
Primary	Correlation between MDS-UPDRS score and its parts with saccadic latency	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	12 months
Primary	Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates	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	12 months
Primary	Correlation between MDS-UPDRS score and its parts with smooth pursuit	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	12 months
Secondary	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