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

NCT ID: NCT05862649

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2025-11-15

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.

Detailed Description

This is an multicenter longitudinal study, in about 300 patients with idiopathic PD in several centers. The aim of this study is to evaluate the correlations between oculometric measures and clinical assessment, e.g. the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the MoCA score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. In addition, the investigators aim to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. All patients will be assessed 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 (Tobii, CE-marked class B approved device) (approx. 30 minutes). The oculometric evaluation will occur for every patient every 3 months. 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 1-2) aged 40-85 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 1-2)
• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Clinical Research Infrastructure Network

OTHER

Sponsor Role: collaborator

NeuraLight

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Januário, MD

Role: PRINCIPAL_INVESTIGATOR

University of Coimbra

Richard Armstrong, MD

Role: PRINCIPAL_INVESTIGATOR

The VCTC

Pablo Mir, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Biomedicina de Sevilla (IBiS

Michelle Tosin, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush Medical University Center

Bettina Balint, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Locations

Rush University

Chicago, Illinois, United States

Site Status: RECRUITING

AIBILI research center

Coimbra, , Portugal

Site Status: RECRUITING

Instituto de Biomedicina de Sevilla (IBiS)

Seville, , Spain

Site Status: RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status: NOT_YET_RECRUITING

The VCTC

Oxford, , United Kingdom

Site Status: RECRUITING

Countries

United States; Portugal; Spain; Switzerland; United Kingdom

Central Contacts

Eitan Raveh, PhD

Role: CONTACT

eitan@neuralight.ai

00972586277944

Facility Contacts

Michelle Tosin, PhD

Role: primary

Other Identifiers

NL/PD/2023-1

Identifier Type: -

Identifier Source: org_study_id