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

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ClinicalTrials.gov Identifier: NCT05437003
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
NeuraLight

Study Description
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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.


Condition or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Other: NeuraLight software-based platform Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : August 20, 2022
Estimated Primary Completion Date : July 20, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PD patients visiting clinic
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
NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients
Experimental: Healthy subjects
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
NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05437003


Contacts
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Contact: Eitan Raveh, PhD +972-58-6277947 eitan@neuralight.ai

Locations
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Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 4941492
Contact: Yafit Peer         
Contact       Yafitpee@clalit.org.il   
Principal Investigator: Johnathan Reiner, MD         
Sponsors and Collaborators
NeuraLight
Investigators
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Principal Investigator: Johnathan Reiner, MD Sackler Faculty of Medicine, Tel Aviv University
More Information
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Publications:

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Responsible Party: NeuraLight
ClinicalTrials.gov Identifier: NCT05437003    
Other Study ID Numbers: NL/PD/2022-1
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not plan to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases