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

NCT05277740 | Unknown

• 2 other identifiers: 2021-7045ETNA-CIS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

multiple sclerosis; clinically isolated syndrome; eye-tracking

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12

  The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval. The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval. The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.

  Baseline and Month 12

Secondary Outcomes (3)

• Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 12

  Baseline and Month 12

• Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 12

  Baseline and Month 12

• Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12

  Baseline and Month 12

Study Arms (3)

CIS

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

Device: Eye-tracking

RRMS

Diagnosis of Relapsing-Remitting MS (RRMS).

Device: Eye-tracking

Healthy Control

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

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.

CIS; Healthy Control; RRMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target sample size for the CIS group is 45. The target sample size for the RRMS group is 45. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.

You may qualify if:

• For all participants
• Able to provide informed consent
• Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)
• For patients only
• Confirmed diagnosis of CIS with abnormal MRI or RRMS
• Neurological condition is medically stable during the study visit

You may not qualify if:

• For all participants:
• Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
• Aged above 65 or less than 18 years of age.
• 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 from performing the eye movement assessments.
• For healthy controls only:
• Evidence or history of significant neurological disorder (Multiple Sclerosis, Parkinson's Disease, Amyotrophic Lateral Sclerosis, Dementia)

Sponsors & Collaborators

• McGill University: lead
• Innodem Neurosciences: collaborator

Study Sites (1)

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; 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 Officials

• Paul S Giacomini, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul S Giacomini, MD

CONTACT

514-244-5060; paul.giacomini@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CA (1)