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NCT Number: NCT05437003

A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients

This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's disease, examined routinely in the neurological outpatient clinic.

This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated following a physician examination.The evaluations will include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In addition, 500 healthy subjects will be evaluated.

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Key information

Conditions

Idiopathic Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center

Petah Tikva, 4941492, Israel

About this study

This is a prospective study in a cohort of patients with idiopathic PD who are visiting the Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

This study is designed to evaluate the correlation between oculometric measures and the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a NeuraLight session for oculometric evaluation along with eye-tracking recordings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

PD patients:

Inclusion criteria

  • Men and women with idiopathic PD (Hoehn & Yahr scale 1-5)
  • 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 20 minutes on a chair in a calm manner
  • Personal or 1st degree relative history of epilepsy
  • Additional neurological diseases
  • Drug or alcohol abuse

Healthy subjects:

Inclusion criteria

  • 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 20 minutes on a chair in a calm manner
  • Personal or 1st degree relative history of epilepsy
  • Neurological diseases
  • Drug or alcohol abuse

Treatment and study plan

NeuraLight software-based platform

Other

NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients

Primary outcomes

  1. Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements

    Time frame: 12 months

    The correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements (R-Square>0.5, p<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at every visit

  2. Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects

    Time frame: 12 months

    Capturing >50 different oculometric measures in >95% of a cohort of about 1000 patients

  3. Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system

    Time frame: 12 months

    Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1

Secondary outcomes

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

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

NeuraLight

Industry

Registry information

Official study title

A Cross-Sectional Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS in Patients With Idiopathic Parkinson's Disease (PD) and Evaluation of Oculometric Measures in Healthy Participants

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2022
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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