Clinical trial NCT05862649: Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: NeuraLight
Sponsor class: INDUSTRY
Collaborators: name: European Clinical Research Infrastructure Network
First posted: 2023-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Change of saccadic latency over time as evaluated during visits
timeFrame: 12 months
measure: Change of anti-saccadic error rates over time as evaluated during visits
timeFrame: 12 months
measure: Change of smooth pursuit speed over time as evaluated during visits
timeFrame: 12 months
measure: Correlation between MDS-UPDRS score and its parts with saccadic latency
timeFrame: 12 months
measure: Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates
timeFrame: 12 months
measure: Correlation between MDS-UPDRS score and its parts with smooth pursuit
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between MoCA score and its parts with saccadic latency
timeFrame: 12 months
measure: Correlation between MoCA score and its parts with anti-saccadic error rates
timeFrame: 12 months
measure: Correlation between MoCA score and its parts with smooth pursuit
timeFrame: 12 months
measure: Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
timeFrame: 12 months
measure: Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MoCA clinical endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Coimbra
country: Portugal
facility: AIBILI research center
city: Sevilla
country: Spain
facility: Instituto de Biomedicina de Sevilla (IBiS)
city: Zürich
country: Switzerland
facility: University Hospital Zürich
city: Oxford
country: United Kingdom
facility: The VCTC
Study officials:
affiliation: University of Coimbra
name: Christina Januário, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The VCTC
name: Richard Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Biomedicina de Sevilla (IBiS
name: Pablo Mir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush Medical University Center
name: Michelle Tosin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Zürich
name: Bettina Balint, MD
role: PRINCIPAL_INVESTIGATOR
References: