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

Parkinson Disease Clinical Trial

— PALOMA  

Official title:

A Multicenter Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and Clinical Assessment in Patients With Idiopathic Parkinson's Disease (PALOMA Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862649
• Other study ID #: NL/PD/2023-1
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: November 2023
• Source: NeuraLight
• Contact: Eitan Raveh, PhD
• Phone: 00972586277944
• Email: eitan[@]neuralight.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• NeuraLight
NeuraLight software-based platform

Locations

Country	Name	City	State
Portugal	AIBILI research center	Coimbra
Spain	Instituto de Biomedicina de Sevilla (IBiS)	Sevilla
Switzerland	University Hospital Zürich	Zürich
United Kingdom	The VCTC	Oxford
United States	Rush University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NeuraLight	European Clinical Research Infrastructure Network

Countries where clinical trial is conducted

United States,  Portugal,  Spain,  Switzerland,  United Kingdom, 

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 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	12 months
Primary	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	12 months
Primary	Correlation between MDS-UPDRS score and its parts with smooth pursuit	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 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	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	12 months
Secondary	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	12 months
Secondary	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	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 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	12 months
Secondary	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	12 months