Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clinically Isolated Syndrome
- Sponsor
- McGill University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12
Time Frame: Baseline and 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.
Secondary Outcomes
- Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12(Baseline and Month 12)
- 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)