A Cross-Sectional Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS in Patients With Idiopathic Parkinson's Disease (PD) and Evaluation of Oculometric Measures in Healthy Participants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic Parkinson Disease
- Sponsor
- NeuraLight
- Enrollment
- 465
- Locations
- 1
- Primary Endpoint
- Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
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:
- •Inclusion Criteria:
- •Age between 18 and 85 years old
- •Normal or corrected vision
- •Ability to follow instructions
- •Willing and able to sign an informed consent form
Outcomes
Primary Outcomes
Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements
Time Frame: 12 months
The correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements (R-Square\>0.5, p\<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at every visit
Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system
Time Frame: 12 months
Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system \<0.1
Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects
Time Frame: 12 months
Capturing \>50 different oculometric measures in \>95% of a cohort of about 1000 patients
Secondary Outcomes
- Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint(12 months)