Multiple SclerosisNCT05061953
Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Innodem Neurosciences at 2 sites in Canada.
Trial 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 MS and non-invasive eye movement measurements in response to visually… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Eye-Tracking
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 168 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Oct 2021to 18 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target sample size for the MS group is 120. Eligible patients will be stratified based on their EDSS score. Based on the known distribution of EDSS scores, we will recruit 46 MS patients with a score between 0-2, 46 patients with a score between 2.5-4, 23 patients with a score between 4.5-6.0, and 23 patients with a score between 6.5-8. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
The Neuro
Montreal, Quebec, H3A 2B4
Julian Santorelli, M.Eng, 514-398-6191, julian.santorelli@mcgill.ca
Pascale Patenaude, MSc., 514-398-7324, pascale.patenaude@mcgill.ca
- Recruiting
Genge Partners, Inc.
Montreal, Quebec, H4A 3T4
Adrien Poulin, 438-874-8334, apoulin@gengepartners.com
Alex Savariano, MD
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Eye-Tracking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-TrackingDevice
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
| Study group | Role | What they receive |
|---|---|---|
| EDSS 0-2.0 | Confirmed diagnosis of MS with an EDSS score between 0 and 2.0. Receives: Device: Eye-Tracking | |
| EDSS 2.5-4.0 | Confirmed diagnosis of MS with an EDSS score between 2.5 and 4.0. Receives: Device: Eye-Tracking | |
| EDSS 4.5-6.0 | Confirmed diagnosis of MS with an EDSS score between 4.5 and 6.0. Receives: Device: Eye-Tracking | |
| EDSS 6.5-8.0 | Confirmed diagnosis of MS with an EDSS score between 6.5 and 8.0. Receives: Device: Eye-Tracking | |
| Healthy Control | Participant with no evidence or history of significant neurodegenerative disorder affecting brain function. Receives: Device: Eye-Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48
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.
Measured: Baseline and Month 48
Secondary outcomes (3)
Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 48
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.
Measured: Baseline and Month 48
Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 48
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)
Measured: Baseline and Month 48
Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 48
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.
Measured: Baseline and Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start18 Oct 2021
- Primary completion18 Oct 2027 (estimated)
- Study completion18 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innodem Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061953
- Sponsor's protocol ID
- ETNA-ProgMS
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05061953
- Acronym / sponsor ID
- ETNA-ProgMS
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Innodem NeurosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 Oct 2027 (estimated)
- Study completion
- 18 Oct 2027 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EDSS 0-2.0 | – | Device: Eye-TrackingConfirmed diagnosis of MS with an EDSS score between 0 and 2.0. |
| EDSS 2.5-4.0 | – | Device: Eye-TrackingConfirmed diagnosis of MS with an EDSS score between 2.5 and 4.0. |
| EDSS 4.5-6.0 | – | Device: Eye-TrackingConfirmed diagnosis of MS with an EDSS score between 4.5 and 6.0. |
| EDSS 6.5-8.0 | – | Device: Eye-TrackingConfirmed diagnosis of MS with an EDSS score between 6.5 and 8.0. |
| Healthy Control | – | Device: Eye-TrackingParticipant with no evidence or history of significant neurodegenerative disorder affecting brain function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target sample size for the MS group is 120. Eligible patients will be stratified based on their EDSS score. Based on the known distribution of EDSS scores, we will recruit 46 MS patients with a score between 0-2, 46 patients with a score between 2.5-4, 23 patients with a score between 4.5-6.0, and 23 patients with a score between 6.5-8. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
- Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-TrackingEye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device. | Device | EDSS 0-2.0, EDSS 2.5-4.0, EDSS 4.5-6.0, EDSS 6.5-8.0, Healthy Control |
Primary outcome
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48
Time frame: Baseline and Month 48
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.
3 secondary outcomes
Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 48
Time frame: Baseline and Month 48
Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 48
Time frame: Baseline and Month 48
Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 48
Time frame: Baseline and Month 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Innodem Neurosciences at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48 (time frame: Baseline and Month 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.