Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by CIS and RRMS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to identify which metrics-or combination thereof-can serve as reliable biomarker of CIS and RRMS disease progression and cognitive status.

Study Overview

• Status: Recruiting
• Conditions: Clinically Isolated Syndrome; Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Device: Eye-tracking

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Paul S Giacomini, MD; Phone Number: 514-244-5060; Email: paul.giacomini@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3A 2B4
      • Recruiting
      • Montreal Neurological Institute and Hospital
      • Contact: Paul Giacomini, MD; Phone Number: 514-244-5060; Email: paul.giacomini@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The target sample size for the CIS group is 45. The target sample size for the RRMS group is 45. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.

Description

Inclusion Criteria:

• For all participants

  1. Able to provide informed consent
  2. Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)

• For patients only

  1. Confirmed diagnosis of CIS with abnormal MRI or RRMS
  2. Neurological condition is medically stable during the study visit

Exclusion Criteria:

• For all participants:

  1. Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
  2. Aged above 65 or less than 18 years of age.
  3. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  4. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent from performing the eye movement assessments.

• For healthy controls only:

  1. Evidence or history of significant neurological disorder (Multiple Sclerosis, Parkinson's Disease, Amyotrophic Lateral Sclerosis, Dementia)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control; Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.	Device: Eye-tracking; Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
CIS; Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI.	Device: Eye-tracking; Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
RRMS; Diagnosis of Relapsing-Remitting MS (RRMS).	Device: Eye-tracking; Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12	The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval. The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval. The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.	Baseline and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 12	The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.	Baseline and Month 12
Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 12	The BICAMS is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment. It includes the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-2 (CVLT2) and the Brief Visuospatial Memory Test-Revised (BVMT-R)	Baseline and Month 12
Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12	A clinical trial outcome measure of assessing the severity of multiple sclerosis (MS) primarily. used in research. The score is based on a combination of timed tests of walking, arm function, and cognitive ability. It is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. The MSFC can produce scores for each of the three individual measures as well as a composite score.	Baseline and Month 12

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Innodem Neurosciences
• Investigators: Principal Investigator: Paul S Giacomini, MD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: multiple sclerosis; eye-tracking; clinically isolated syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 2021-7045; ETNA-CIS (Other Identifier: McGill University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified metrics (e.g. age, medication intake, cognitive scores) will be uploaded onto a secure could-based server of collaborator (Innodem) for data analysis purposes, and will not be shared with anyone other than the collaborator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No