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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05437003
Other study ID # NL/PD/2022-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2022
Est. completion date February 15, 2024

Study information

Verified date February 2024
Source NeuraLight
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 465
Est. completion date February 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Rabin Medical Center Petach Tikva

Sponsors (1)

Lead Sponsor Collaborator
NeuraLight

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Primary 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 12 months
Primary 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 12 months
Secondary 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 12 months
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