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

NCT05437003 | Completed

• 1 other identifier: NL/PD/2022-1
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (3)

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

  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

  12 months

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

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

  12 months

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

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

  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 (2)

PD patients visiting clinic

EXPERIMENTAL

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.

Other: NeuraLight software-based platform

Healthy subjects

EXPERIMENTAL

All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a visit unless authorized to be conducted remotely.

Other: NeuraLight software-based platform

Interventions

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

Healthy subjects; PD patients visiting clinic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NeuraLight: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Related Publications (2)

• Anderson TJ, MacAskill MR. Eye movements in patients with neurodegenerative disorders. Nat Rev Neurol. 2013 Feb;9(2):74-85. doi: 10.1038/nrneurol.2012.273. Epub 2013 Jan 22.

  PMID: 23338283 BACKGROUND

• Waldthaler J, Tsitsi P, Svenningsson P. Vertical saccades and antisaccades: complementary markers for motor and cognitive impairment in Parkinson's disease. NPJ Parkinsons Dis. 2019 Jun 24;5:11. doi: 10.1038/s41531-019-0083-7. eCollection 2019.

  PMID: 31263745 BACKGROUND

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

• Johnathan Reiner, MD

  Sackler Faculty of Medicine, Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: August 20, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)