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Recruiting NCT05862649

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

Trial Parameters

Condition Parkinson Disease
Sponsor NeuraLight
Study Type INTERVENTIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 40 Years
Max Age 85 Years
Start Date 2023-08-21
Completion 2025-11-15
Interventions
NeuraLight

Brief 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 Criteria

Inclusion Criteria: * Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2) * Age between 40 and 85 years old * 0 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 Criteria: * 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)

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