Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis

NCT ID: NCT06283524

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2026-03-18

Brief Summary

The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in MS patients to train machine learning algorithms that will support the development and performance assessment of a sensitive and non-invasive eye-tracking software application. The training of our 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Single cohort of MS patients with EDSS 1.0-8.0

Confirmed diagnosis of MS with an EDSS score ranging from 1.0 and 8.0.

Eye-Tracking

Intervention Type: DEVICE

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

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.

Intervention Type: DEVICE

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
• Able to read the oculomotor task on-screen instructions at the testing distance (45cm) with or without corrective lenses
• Confirmed diagnosis of MS as per the Macdonald criteria, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS))
• Neurologist-determined EDSS score between 1.0-8.0

Exclusion Criteria

• Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control
• Presence of comorbid 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
• Having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics and anticonvulsants) within the past three months
• Participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innodem Neurosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Genge Partners, Inc.

Montreal, Quebec, Canada

Countries

Canada

Facility Contacts

Yousri Benchaar

Role: primary

YBenchaar@gengepartners.com

514-906-3876 ext. 6026

Other Identifiers

ETNA-TrainMS

Identifier Type: -

Identifier Source: org_study_id