Recruiting

Eye-Tracking Biomarker

Sponsor:

McGill University

Code:

NCT05277740

Conditions

Clinically Isolated Syndrome

Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Eye-tracking

Study Details

Brief summary:

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.

Conditions

Clinically Isolated Syndrome

Relapsing Remitting Multiple Sclerosis

Study ID

NCT05277740

Start date

Sep 1, 2022

Status verified date

Nov, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

CIS

Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI.

RRMS

Diagnosis of Relapsing-Remitting MS (RRMS).

Healthy Control

Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.

Interventions

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.

Primary outcome measure

  • Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12 [ Time Frame: Baseline and Month 12 ]

Central Contacts and Locations

Central contacts

Paul S Giacomini, MD

514-244-5060paul.giacomini@mcgill.ca

Locations

Montreal Neurological Institute and Hospital

Recruiting

Montréal, Quebec, Canada, H3A 2B4

Contacts

Paul Giacomini, MD

514-244-5060paul.giacomini@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Nov 9, 2023

Last verified

Nov, 2023

Keywords

  • multiple sclerosis
  • clinically isolated syndrome
  • eye-tracking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2023-11-09.