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Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis

Study Purpose

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 MS 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 track the progressive component of multiple sclerosis and associated cognitive changes.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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) For patients only: - 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.

- Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit.

Exclusion Criteria:

- Evidence or medical history of psychiatric issues that are known to also affect movements and oculomotor control.

- Presence of co-morbid 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. For healthy controls only:

- Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia.

For MS patients only.

- 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 (McDonald et al. 2001). 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05061953
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Innodem Neurosciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

: EDSS 0-2.0

Confirmed diagnosis of MS with an EDSS score between 0 and 2.0.

: EDSS 2.5-4.0

Confirmed diagnosis of MS with an EDSS score between 2.5 and 4.0.

: EDSS 4.5-6.0

Confirmed diagnosis of MS with an EDSS score between 4.5 and 6.0.

: EDSS 6.5-8.0

Confirmed diagnosis of MS with an EDSS score between 6.5 and 8.0.

: Healthy Control

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

Interventions

Device: - Eye-Tracking

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.