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

Idiopathic Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05437003
• Other study ID #: NL/PD/2022-1
• Status: Completed
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: NeuraLight
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
NeuraLight

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint	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	12 months