A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2024-02-15

Brief Summary

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This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's disease, examined routinely in the neurological outpatient clinic.

This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated following a physician examination.The evaluations will include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In addition, 500 healthy subjects will be evaluated.

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Detailed Description

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This is a prospective study in a cohort of patients with idiopathic PD who are visiting the Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

This study is designed to evaluate the correlation between oculometric measures and the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a NeuraLight session for oculometric evaluation along with eye-tracking recordings.

Conditions

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Idiopathic Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PD patients visiting clinic

All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.

Group Type EXPERIMENTAL

NeuraLight software-based platform

Intervention Type OTHER

NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients

Healthy subjects

All patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a visit unless authorized to be conducted remotely.

Group Type EXPERIMENTAL

NeuraLight software-based platform

Intervention Type OTHER

NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients

Interventions

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NeuraLight software-based platform

NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women with idiopathic PD (Hoehn \& Yahr scale 1-5)
* Age between 18 and 85 years old
* Normal or corrected vision
* Ability to follow instructions
* Willing and able to sign an informed consent form

* 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 20 minutes on a chair in a calm manner
* Personal or 1st degree relative history of epilepsy
* Additional neurological diseases
* Drug or alcohol abuse

Healthy subjects:

* Inability to sit for 20 minutes on a chair in a calm manner
* Personal or 1st degree relative history of epilepsy
* Neurological diseases
* Drug or alcohol abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes