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

NCT05061953 | Recruiting

• 1 other identifier: ETNA-ProgMS
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 2

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 MS 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 track the progressive component of multiple sclerosis and associated cognitive changes.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48

  The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.

  Baseline and Month 48

Secondary Outcomes (3)

• Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 48

  Baseline and Month 48

• Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 48

  Baseline and Month 48

• Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 48

  Baseline and Month 48

Study Arms (5)

EDSS 0-2.0

Confirmed diagnosis of MS with an EDSS score between 0 and 2.0.

Device: Eye-Tracking

EDSS 2.5-4.0

Confirmed diagnosis of MS with an EDSS score between 2.5 and 4.0.

Device: Eye-Tracking

EDSS 4.5-6.0

Confirmed diagnosis of MS with an EDSS score between 4.5 and 6.0.

Device: Eye-Tracking

EDSS 6.5-8.0

Confirmed diagnosis of MS with an EDSS score between 6.5 and 8.0.

Device: Eye-Tracking

Healthy Control

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

Device: Eye-Tracking

Interventions

Eye-Tracking 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.

EDSS 0-2.0; EDSS 2.5-4.0; EDSS 4.5-6.0; EDSS 6.5-8.0; Healthy Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target sample size for the MS group is 120. Eligible patients will be stratified based on their EDSS score. Based on the known distribution of EDSS scores, we will recruit 46 MS patients with a score between 0-2, 46 patients with a score between 2.5-4, 23 patients with a score between 4.5-6.0, and 23 patients with a score between 6.5-8. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Innodem Neurosciences: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (2)

The Neuro

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

Genge Partners, Inc.

Montreal, Quebec, H4A 3T4, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): October 18, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CA (2)