A Longitudinal Evaluation of Oculometric Measures and Clinical Assessment Over Time in PD Patients

October 28, 2024 updated by: NeuraLight

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Tel Aviv, Israel, 6423906
        • Movement Disorders Unit, Sourasky Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PD patients
Men and women with idiopathic PD (Hoehn & Yahr scale 1-3) aged 18-85 years
Other: NeuraLight
NeuraLight software-based platform

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of saccadic latency over time as evaluated during visits
Time Frame: 12 months
Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p>0.05) over time during study period
12 months
Change of anti-saccadic error rates over time as evaluated during visits
Time Frame: 12 months
Difference between anti-saccadic error rates (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p>0.05) over time during study period
12 months
Change of smooth pursuit speed over time as evaluated during visits
Time Frame: 12 months
Difference between smooth pursuit speed (ms)as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p>0.05) over time during study period
12 months
Correlation between MDS-UPDRS score and its parts with saccadic latency
Time Frame: 12 months
The correlation between MDS-UPDRS score and its parts with saccadic latency (ms) measured using R-Square (high correlation>0.5, moderate correlation 0.2-0.5, low correlation<0.2), p<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
12 months
Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates
Time Frame: 12 months
The correlation between MDS-UPDRS score and its parts with anti-saccadic error rates (%), measured using R-Square (high correlation>0.5, moderate correlation 0.2-0.5, low correlation<0.2), p<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
12 months
Correlation between MDS-UPDRS score and its parts with smooth pursuit
Time Frame: 12 months
The correlation between MDS-UPDRS score and its parts with smooth pursuit speed (ms) measured using R-Square (high correlation>0.5, moderate correlation 0.2-0.5, low correlation<0.2), p<0.05) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NeuraLight

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tanya Gurevich, MD, Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL/PD/2022-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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