A Multicenter Longitudinal Study to Evaluate the Correlation between Oculometric Measures and Clinical Assessment in Patients with Idiopathic Parkinson's Disease (PALOMA trial)

Study ID: 56797
Short Title: PALOMA
Organisation: Hampshire Hospitals NHS Foundation Trust
Location: Basingstoke and North Hampshire Hospital
Condition: Parkinson's disease
Main Specialty: Neurological disorders
Expected End Date: 30/11/2023
Postcode: RG24 9NA, SO22 5DG
Contact Name: R&D department
Contact Email: research.team@hhft.nhs.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

• Men and women with idiopathic PD (Hoehn & Yahr scale 1-2) • Age between 40 and 85 years old • 0-5 years 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 current treatment for at least 3 months.

• 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 (except for using medical cannabis during 24 hours prior NL examination date) • Pregnancy or a potential pregnancy (self-declaration).

This is an observational prospective longitudinal multicenter study, in a population of up to 300 patients with idiopathic PD. All patients will be assessed using MDS-UPDRS and MoCA test over a period of 12 months (5 assessments, at 0, 3, 6, 9, 12 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. No randomisation is applicable.

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