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

NeuraLight

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: NeuraLight

Study type

Interventional

Funder types

Industry

Identifiers

NCT05795023

NL/PD/2022-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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)