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

Study 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.

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

Conditions
-----------------
Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: Eye-tracking


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CIS<br>Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI. | Device: Eye-tracking<br>* Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.<br>|
| RRMS<br>Diagnosis of Relapsing-Remitting MS (RRMS). | Device: Eye-tracking<br>* Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.<br>|
| Healthy Control<br>Participant with no evidence or history of significant neurodegenerative disorder affecting brain function. | Device: Eye-tracking<br>* Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 12 | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. | Baseline and Month 12 | 
| Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 12 | The BICAMS is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment. It includes the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-2 (CVLT2) and the Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline and Month 12 | 
| Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12 | A clinical trial outcome measure of assessing the severity of multiple sclerosis (MS) primarily. used in research. The score is based on a combination of timed tests of walking, arm function, and cognitive ability. It is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. The MSFC can produce scores for each of the three individual measures as well as a composite score. | Baseline and Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, clinically isolated syndrome, eye-tracking