NCT05661266

Investigating Eye-Movement Biomarkers of Disease Severity and Cognition in Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Innodem Neurosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in multiple sclerosis (MS) patients to further build up a database of MS patients and train a machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status.

Detailed description

This study will use a single group design in a cohort of MS patients. Eligible patients with MS will be selected and categorized based on their Expanded Disability Status Scale (EDSS) score. Patients eye movements will be captured using the patented eye-tracking technology at one single time point. In addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the EDSS, Brief International Cognitive Assessment for MS (BICAMS) and Multiple Sclerosis Functional Composite (MSFC). All patients will be required to participate in a single session.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-16
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-12-22
• Last updated: 2026-04-01

Locations

1 site across 1 country: Canada