Developing a new eye-tracking tool for assessing multiple sclerosis

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

This study is trying to create a new eye-tracking tool to help understand how multiple sclerosis affects eye movements and thinking in people with the condition.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: McGill University (Academic / other)
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT05277740 on ClinicalTrials.gov

What this trial studies

This observational study aims to create and validate a non-invasive eye-tracking software application that measures eye movements in response to visual stimuli. Participants will undergo cognitive tests and eye movement assessments to gather data on clinically isolated syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS). The collected data will be used to develop machine learning algorithms to identify reliable biomarkers for disease progression and cognitive status in these conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 65 with a confirmed diagnosis of clinically isolated syndrome or relapsing-remitting multiple sclerosis.

Not a fit: Patients with significant psychiatric issues, other neurological conditions, or severe ocular disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, sensitive method for monitoring disease progression and cognitive impairment in multiple sclerosis patients.

How similar studies have performed: Other studies utilizing eye-tracking technology have shown promise in assessing neurological conditions, suggesting potential success for this novel approach.

Eligibility criteria

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)

Where this trial is running

Montréal, Quebec

• Montreal Neurological Institute and Hospital — Montréal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Paul S Giacomini, MD — McGill University
• Study coordinator: Paul S Giacomini, MD

Conditions Clinically Isolated Syndrome; Relapsing Remitting Multiple Sclerosis; multiple sclerosis; clinically isolated syndrome; eye-tracking