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

NCT05862649 | Completed

• 1 other identifier: NL/PD/2023-1
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Correlation between MoCA score and its parts with saccadic latency

  12 months

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

  12 months

• Correlation between MoCA score and its parts with smooth pursuit

  12 months

• Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint

  12 months

• Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MoCA clinical endpoint

  12 months

Study Arms (1)

PD patients

EXPERIMENTAL

Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2) aged 40-85 years

Other: NeuraLight

Interventions

NeuraLight OTHER

NeuraLight software-based platform

PD patients

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2)
• Age between 40 and 85 years old
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NeuraLight: lead
• European Clinical Research Infrastructure Network: collaborator

Study Sites (5)

Rush University

Chicago, Illinois, 60612, United States

Location

AIBILI research center

Coimbra, Portugal

Location

Instituto de Biomedicina de Sevilla (IBiS)

Seville, Spain

Location

University Hospital Zürich

Zurich, Switzerland

Location

The VCTC

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: August 21, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1); CH (1); PT (1); ES (1)