Development of a new eye-tracking software for Multiple Sclerosis

Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis

This study is testing a new eye-tracking software to see if it can help understand how Multiple Sclerosis affects thinking and vision.

Quick facts

• Study type: Observational
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innodem Neurosciences (Industry-sponsored)
• Locations: 2 sites (Montreal, Quebec and 1 other locations)
• Trial ID: NCT05061953 on ClinicalTrials.gov

What this trial studies

This study focuses on creating and validating a non-invasive eye-tracking software application designed to assess cognitive functions affected by Multiple Sclerosis (MS). Participants will undergo brief cognitive tests alongside eye movement measurements in response to visual stimuli during specialized eye-tracking assessments. The collected data will be utilized to develop machine learning algorithms aimed at tracking the progression of MS and related cognitive changes. The study aims to enhance the understanding of MS through innovative technology.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of MS who are stable and have an EDSS score between 0 and 8.0.

Not a fit: Patients with psychiatric issues affecting movement, co-morbid neurological conditions, or significant ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this software could provide a more sensitive and objective method for monitoring cognitive changes in patients with Multiple Sclerosis.

How similar studies have performed: While the approach of using eye-tracking technology in MS is innovative, similar studies have shown promise in utilizing eye movement as a biomarker for cognitive assessment.

Eligibility criteria

Inclusion Criteria:

* Able to provide informed consent.
* Aged 18 years or older at the time of enrollment.
* Able to read in either French or English.
* Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc.

are permitted)

For patients only:

* Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months.
* Neurological condition is medically stable during the study visit.
* Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit.

Exclusion Criteria:

* Evidence or medical history of psychiatric issues that are known to also affect movements and oculomotor control.
* Presence of co-morbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
* Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
* Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.

For healthy controls only:

* Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia.

For MS patients only

* Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS).
* Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event (McDonald et al. 2001). The abnormality must have been present for at least 24 hours and occurred in the absence of fever (\< 37.5°C) or known infection.
* Patients who have been undergoing disease-modifying therapy for less than three months

Where this trial is running

Montreal, Quebec and 1 other locations

• The Neuro — Montreal, Quebec, Canada (Recruiting)
• Genge Partners, Inc. — Montreal, Quebec, Canada (Recruiting)

Conditions Multiple Sclerosis