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

NCT ID: NCT05277740

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-07-31

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 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.

Conditions

Clinically Isolated Syndrome; Relapsing Remitting Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CIS

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

Eye-tracking

Intervention Type: 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.

RRMS

Diagnosis of Relapsing-Remitting MS (RRMS).

Eye-tracking

Intervention Type: 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.

Healthy Control

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

Eye-tracking

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innodem Neurosciences

INDUSTRY

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul S Giacomini, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Paul S Giacomini, MD

Role: CONTACT

paul.giacomini@mcgill.ca

514-244-5060

Facility Contacts

Paul Giacomini, MD

Role: primary

paul.giacomini@mcgill.ca

514-244-5060

Other Identifiers

ETNA-CIS

Identifier Type: OTHER

Identifier Source: secondary_id

2021-7045

Identifier Type: -

Identifier Source: org_study_id