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

NCT05862649 · NeuraLight
In plain English

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Official title
A Multicenter Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and Clinical Assessment in Patients With Idiopathic Parkinson's Disease (PALOMA Trial)
About this study
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.
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)
Study design
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-08-21
Estimated completion: 2025-11-15
Last updated: 2025-05-20
Interventions
Other: NeuraLight
Primary outcomes
  • Change of saccadic latency over time as evaluated during visits (12 months)
  • Change of anti-saccadic error rates over time as evaluated during visits (12 months)
  • Change of smooth pursuit speed over time as evaluated during visits (12 months)
Sponsor
NeuraLight · industry
With: European Clinical Research Infrastructure Network
Contacts & investigators
ContactEitan Raveh, PhD · contact · eitan@neuralight.ai · 00972586277944
InvestigatorChristina Januário, MD · principal_investigator, University of Coimbra
InvestigatorRichard Armstrong, MD · principal_investigator, The VCTC
InvestigatorPablo Mir, MD · principal_investigator, Instituto de Biomedicina de Sevilla (IBiS
All locations (5)
Rush UniversityRecruiting
Chicago, Illinois, United States
AIBILI research centerRecruiting
Coimbra, Portugal
Instituto de Biomedicina de Sevilla (IBiS)Recruiting
Seville, Spain
University Hospital ZürichNot Yet Recruiting
Zurich, Switzerland
The VCTCRecruiting
Oxford, United Kingdom
Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease · TrialPath