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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: NeuraLight

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eitan Raveh, PhD; Phone Number: 00972586277944; Email: eitan@neuralight.ai

Study Locations

• Portugal
  • Coimbra, Portugal
    • Recruiting
    • AIBILI research center
• Spain
  • Sevilla, Spain
    • Recruiting
    • Instituto de Biomedicina de Sevilla (IBiS)
• Switzerland
  • Zürich, Switzerland
    • Not yet recruiting
    • University Hospital Zurich
• United Kingdom
  • Oxford, United Kingdom
    • Recruiting
    • The VCTC
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University
      • Contact: Michelle Tosin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD patients; Men and women with idiopathic PD (Hoehn & Yahr scale 1-2) aged 40-85 years	Other: NeuraLight; NeuraLight software-based platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: NeuraLight
• Collaborators: European Clinical Research Infrastructure Network
• Investigators: Principal Investigator: Christina Januário, MD, University of Coimbra; Principal Investigator: Richard Armstrong, MD, The VCTC; Principal Investigator: Pablo Mir, MD, Instituto de Biomedicina de Sevilla (IBiS; Principal Investigator: Michelle Tosin, PhD, Rush Medical University Center; Principal Investigator: Bettina Balint, MD, University Hospital, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NL/PD/2023-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No