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

NCT05795023 | Completed

• 1 other identifier: NL/PD/2022-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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 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

• 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

• 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 Outcomes (1)

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

  12 months

Study Arms (1)

PD patients

EXPERIMENTAL

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

Other: NeuraLight

Interventions

NeuraLight OTHER

NeuraLight software-based platform

PD patients

Eligibility Criteria

• Age: 18 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 1-3)
• Age between 18 and 85 years old
• Normal or corrected vision
• Ability to follow instructions
• Willing and able to sign an informed consent form

You may not qualify if:

• 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)

Sponsors & Collaborators

• NeuraLight: lead

Study Sites (1)

Movement Disorders Unit, Sourasky Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

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

• Tanya Gurevich, MD

  Tel Aviv Medical Center

  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

Model Details: All patients will be assessed with MDS-UPDRS and oculometric examination over time

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: May 8, 2023
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)