Clinical trial NCT05795023: A Longitudinal Evaluation of Oculometric Measures and Clinical Assessment Over Time in PD Patients
Official title: A Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS Over Time in a Cohort of Patients With Idiopathic Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: NeuraLight
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will be assessed with MDS-UPDRS and oculometric examination over time
Primary purpose: OTHER

Brief summary: This is a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated 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.

Detailed description: This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 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 during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). 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 1-3)
* Age between 18 and 85 years old
* Normal or corrected vision
* Ability to follow instructions
* Willing and able to sign an informed consent form

Exclusion Criteria:

* Inability to sit for 30 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: Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Movement Disorders Unit, Sourasky Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Tanya Gurevich, MD
role: PRINCIPAL_INVESTIGATOR
References: