Recruiting

Eye-Tracking Software

Sponsor:

Innodem Neurosciences

Code:

NCT05061953

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Eye-Tracking

Study Details

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

Study ID

NCT05061953

Start date

Oct 18, 2021

Status verified date

Mar, 2026

Completion date

Oct 18, 2027

Anticipated

Primary completion date

Oct 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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)

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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

168 participants

Anticipated

Interventions and Outcome Measures

Arms

EDSS 0-2.0

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

EDSS 2.5-4.0

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

EDSS 4.5-6.0

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

EDSS 6.5-8.0

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

Healthy Control

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

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

  • Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48 [ Time Frame: Baseline and Month 48 ]

Central Contacts and Locations

Locations

The Neuro

Recruiting

Montreal, Quebec, Canada, H3A 2B4

Contacts

Julian Santorelli, M.Eng

514-398-6191julian.santorelli@mcgill.ca

Pascale Patenaude, MSc.

514-398-7324pascale.patenaude@mcgill.ca

Principal Investigator:

Paul Giacomini, MD

Genge Partners, Inc.

Recruiting

Montreal, Quebec, Canada, H4A 3T4

Contacts

Adrien Poulin

438-874-8334apoulin@gengepartners.com

Principal Investigator:

Alex Savariano, MD

More Information

Sponsor

Innodem Neurosciences

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innodem Neurosciences on 2026-04-01.