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Eye-Movement Biomarkers

Sponsor:

Innodem Neurosciences

Code:

NCT05661266

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eye-Tracking

Study Details

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

Study ID

NCT05661266

Start date

Aug 16, 2023

Status verified date

Oct, 2023

Completion date

Apr, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)
  • 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.

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.
  • 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Single cohort of MS patients with EDSS 0-8.0

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

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.

Primary outcome measure

  • Predictive power of eye-movement biomarkers (EMBs) for MS severity in relationship to Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 ]

Central Contacts and Locations

Locations

Genge Partners, Inc.

Recruiting

Montreal, Quebec, Canada, H4A 3T4

Contacts

Yousri Benchaar

514-906-3876YBenchaar@gengepartners.com

Principal Investigator:

Alex Savariano, MD

More Information

Sponsor

Innodem Neurosciences

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Innodem Neurosciences on 2023-10-18.