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

NCT05661266 | Completed

• 1 other identifier: ETNA-subMS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Predictive power of eye-movement biomarkers (EMBs) for MS severity in relationship to Expanded Disability Status Scale (EDSS)

  Estimate the extent to which EMBs can accurately predict MS severity (as assessed with the EDSS tool). The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

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Secondary Outcomes (5)

• Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS).

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• Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the the California Verbal Learning Test-2 (CVLT2) as part of the Brief International Cognitive Assessment for MS (BICAMS).

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• Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS).

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• Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC).

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• Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC).

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Study Arms (1)

Single cohort of MS patients with EDSS 0-8.0

Confirmed diagnosis of MS with an EDSS score ranging from 0 and 8.0.

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.

Single cohort of MS patients with EDSS 0-8.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Our target sample size for the MS group is 120. Eligible patients with MS will be selected and categorized based on their EDSS score.

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)
• 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.

You may not qualify if:

• 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.
• 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
• 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. 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

Study Sites (1)

Genge Partners, Inc.

Montreal, Quebec, H4A 3T4, Canada

Location

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
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 22, 2022
• Study Start: August 16, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 1, 2026

Record last verified: 2023-10

Locations

CA (1)