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Implementation of a Novel Functional Eye-Tracking Biomarker 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 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.

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 - 65 Years
Gender	All

More Inclusion & Exclusion 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)

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.	NCT05277740
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.	McGill University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Paul S Giacomini, MD
Principal Investigator Affiliation	McGill University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis

Arms & Interventions

Arms

: CIS

Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI.

: RRMS

Diagnosis of Relapsing-Remitting MS (RRMS).

: 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.

International Sites

Montréal, Quebec, Canada

Status

Recruiting

Address

Montreal Neurological Institute and Hospital

Montréal, Quebec, H3A 2B4

Site Contact

Paul Giacomini, MD

[email protected]

514-244-5060

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