Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis

McGill University

Status: Enrolling

Conditions: Relapsing Remitting Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Device: Eye-tracking

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05277740

ETNA-CIS (Other Identifier)

2021-7045

Details and patient eligibility

About

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 CIS and RRMS 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 identify which metrics-or combination thereof-can serve as reliable biomarker of CIS and RRMS disease progression and cognitive status.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• For all participants

  1. Able to provide informed consent
  2. Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)

• For patients only

  1. Confirmed diagnosis of CIS with abnormal MRI or RRMS
  2. Neurological condition is medically stable during the study visit

Exclusion criteria

• For all participants:

  1. Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
  2. Aged above 65 or less than 18 years of age.
  3. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  4. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent from performing the eye movement assessments.

• For healthy controls only:

  1. Evidence or history of significant neurological disorder (Multiple Sclerosis, Parkinson's Disease, Amyotrophic Lateral Sclerosis, Dementia)

Trial design

120 participants in 3 patient groups

CIS

Description:

Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI.

Treatment:

Device: Eye-tracking

RRMS

Description:

Diagnosis of Relapsing-Remitting MS (RRMS).

Treatment:

Device: Eye-tracking

Healthy Control

Description:

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

Treatment:

Device: Eye-tracking