RecruitingNot ApplicableNCT05862649

Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease

A Multicenter Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and Clinical Assessment in Patients With Idiopathic Parkinson's Disease (PALOMA Trial)

Sponsor

NeuraLight

Enrollment

300 participants

Start Date

Aug 21, 2023

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinson's disease, who will be evaluated in several clinical centers 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, as well as the potential to detect early change in clinical status using an oculometric assessment.

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Inclusion Criteria8

Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2)
Age between 40 and 85 years old
to 5 years' time since diagnosis
Normal or corrected vision
Ability to follow instructions
Willing and able to sign an informed consent form
No anticipated changes in PD medications from baseline throughout the study duration based on clinical status during screening
If treated, stable on treatment for at least 3 months

Exclusion Criteria5

Inability to sit for 40 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)