Clinical trial NCT05277740: Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Official title: Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinically Isolated Syndrome
Relapsing Remitting Multiple Sclerosis
Keywords: multiple sclerosis
clinically isolated syndrome
eye-tracking
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Innodem Neurosciences
First posted: 2022-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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)

Primary outcomes:
measure: Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 12
timeFrame: Baseline and Month 12
measure: Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 12
timeFrame: Baseline and Month 12
measure: Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Paul S Giacomini, MD
role: PRINCIPAL_INVESTIGATOR
References: