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

NCT ID: NCT05795023

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2024-10-28

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.

Detailed Description

This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 months). During this time period, every subject who consents will undergo a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye- tracking system (Tobii, CE-marked class B approved device) (approx. 30 minutes). The oculometric evaluation will occur during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PD patients

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

Group Type: EXPERIMENTAL

NeuraLight

Intervention Type: OTHER

NeuraLight software-based platform

Interventions

NeuraLight

NeuraLight software-based platform

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuraLight

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanya Gurevich, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Movement Disorders Unit, Sourasky Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

NL/PD/2022-3

Identifier Type: -

Identifier Source: org_study_id