A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients
Primary Purpose
Idiopathic Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NeuraLight software-based platform
Sponsored by
About this trial
This is an interventional other trial for Idiopathic Parkinson Disease
Eligibility Criteria
PD patients:
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
Exclusion Criteria
- 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
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PD patients visiting clinic
Healthy subjects
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements
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
Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects
Capturing >50 different oculometric measures in >95% of a cohort of about 1000 patients
Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system
Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1
Secondary Outcome Measures
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of MDS-UPDRS with a relative root mean square error (RMSE) of <0.1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437003
Brief Title
A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuraLight
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD patients visiting clinic
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NeuraLight software-based platform
Intervention Description
NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including PD patients
Primary Outcome Measure Information:
Title
Correlation between MDS-UPDRS score and its parts with NeuraLight oculometric measurements
Description
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
Time Frame
12 months
Title
Feasibility of using NeuraLight system to capture oculometric measures in a cohort of PD patients and healthy subjects
Description
Capturing >50 different oculometric measures in >95% of a cohort of about 1000 patients
Time Frame
12 months
Title
Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system
Description
Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system <0.1
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
Description
Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of MDS-UPDRS with a relative root mean square error (RMSE) of <0.1
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
PD patients:
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
Exclusion Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eitan Raveh, PhD
Phone
+972-58-6277947
Email
eitan@neuralight.ai
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnathan Reiner, MD
Organizational Affiliation
Sackler Faculty of Medicine, Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yafit Peer
Email
Yafitpee@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Johnathan Reiner, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not plan to share IPD with other researchers
Citations:
PubMed Identifier
23338283
Citation
Anderson TJ, MacAskill MR. Eye movements in patients with neurodegenerative disorders. Nat Rev Neurol. 2013 Feb;9(2):74-85. doi: 10.1038/nrneurol.2012.273. Epub 2013 Jan 22.
Results Reference
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PubMed Identifier
31263745
Citation
Waldthaler J, Tsitsi P, Svenningsson P. Vertical saccades and antisaccades: complementary markers for motor and cognitive impairment in Parkinson's disease. NPJ Parkinsons Dis. 2019 Jun 24;5:11. doi: 10.1038/s41531-019-0083-7. eCollection 2019.
Results Reference
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A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients
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