Investigating eye movements in multiple sclerosis patients
Investigating Eye-Movement Biomarkers of Disease Severity and Cognition in Multiple Sclerosis
This study is testing how eye movements can help us understand the severity of multiple sclerosis and cognitive function in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innodem Neurosciences Industry-sponsored |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05661266 on ClinicalTrials.gov |
What this trial studies
This research aims to collect eye-tracking data, cognitive assessments, and disease severity metrics from patients with multiple sclerosis (MS). The study will categorize participants based on their Expanded Disability Status Scale (EDSS) scores and utilize patented eye-tracking technology to capture their eye movements during a single session. Additionally, cognitive performance will be evaluated using standardized assessments like the Brief International Cognitive Assessment for MS (BICAMS) and the Multiple Sclerosis Functional Composite (MSFC). The goal is to develop machine learning algorithms that can identify reliable eye-tracking biomarkers for MS severity and cognitive status.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of multiple sclerosis who are medically stable.
Not a fit: Patients with psychiatric issues or other neurological conditions that could affect eye movements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing disease severity and cognitive function in MS patients.
How similar studies have performed: While the use of eye-tracking in MS is an emerging field, similar studies have shown promise in identifying cognitive and functional impairments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide informed consent. * Aged 18 years or older at the time of enrollment. * Able to read in either French or English. * Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted) * Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months. * Neurological condition is medically stable during the study visit. Exclusion Criteria: * Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control. * 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 a participant from performing the eye movement assessments. * Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment * Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS). * Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must have been present for at least 24 hours and occurred in the absence of fever (\< 37.5°C) or known infection. * Patients who have been undergoing disease-modifying therapy for less than three months
Where this trial is running
Montreal, Quebec
- Genge Partners, Inc. — Montreal, Quebec, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.