Clinically Isolated SyndromeNCT05277740
Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
An observational study of Clinically Isolated Syndrome and Relapsing Remitting Multiple Sclerosis, run by McGill University at 1 site 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 CIS and RRMS and non-invasive eye movement measurements in response to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Eye-tracking
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target sample size for the CIS group is 45. The target sample size for the RRMS group is 45. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Paul Giacomini, MD, 514-244-5060, paul.giacomini@mcgill.ca
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 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.
- Being tested
- Eye-tracking
- Keywords
- multiple sclerosis, clinically isolated syndrome, eye-tracking
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, 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 |
|---|---|---|
| CIS | Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI. Receives: Device: Eye-tracking | |
| RRMS | Diagnosis of Relapsing-Remitting MS (RRMS). 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 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.
Measured: Baseline and Month 12
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Sep 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Isolated SyndromeStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Innodem Neurosciences
- Responsible party
- Sponsor
- Investigators
- Paul S Giacomini, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277740
- Sponsor's protocol ID
- 2021-7045
- Other IDs
- ETNA-CIS
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified metrics (e.g. age, medication intake, cognitive scores) will be uploaded onto a secure could-based server of collaborator (Innodem) for data analysis purposes, and will not be shared with anyone other than the collaborator.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05277740
- Acronym / sponsor ID
- 2021-7045
- Keywords
- multiple sclerosis, clinically isolated syndrome, eye-tracking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Innodem Neurosciences
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 14 Mar 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CIS | – | Device: Eye-trackingDiagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI. |
| RRMS | – | Device: Eye-trackingDiagnosis of Relapsing-Remitting MS (RRMS). |
| Healthy Control | – | Device: Eye-trackingParticipant with no evidence or history of significant neurodegenerative disorder affecting brain function. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target sample size for the CIS group is 45. The target sample size for the RRMS group is 45. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.
Key inclusion criteria (6 listed)
- For all participants
- For patients only
Key exclusion criteria (7 listed)
- For all participants:
- For healthy controls only:
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 | CIS, Healthy Control, RRMS |
Primary outcome
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12
Time frame: Baseline and 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.
3 secondary outcomes
Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 12
Time frame: Baseline and Month 12
Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 12
Time frame: Baseline and Month 12
Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12
Time frame: Baseline and Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided. De-identified metrics (e.g. age, medication intake, cognitive scores) will be uploaded onto a secure could-based server of collaborator (Innodem) for data analysis purposes, and will not be shared with anyone other than the collaborator.
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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. This study is not recruiting at the moment.
Paul S Giacomini, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Isolated Syndrome and Relapsing Remitting Multiple Sclerosis, run by McGill University at 1 site 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul S Giacomini, MD (514-244-5060, paul.giacomini@mcgill.ca), or a site near the patient. 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 12 (time frame: Baseline and Month 12). 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 9 Nov 2023.