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| ID | Type | Description | Link |
|---|---|---|---|
| ETNA-CIS | Other Identifier | McGill University |
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| Name | Class |
|---|---|
| Innodem Neurosciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIS | Diagnosis of Clinically Isolated Syndrome (CIS) with abnormal MRI. |
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| RRMS | Diagnosis of Relapsing-Remitting MS (RRMS). |
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| Healthy Control | Participant with no evidence or history of significant neurodegenerative disorder affecting brain function. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye-tracking | Device | Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For all participants
For patients only
Exclusion Criteria:
For all participants:
For healthy controls only:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul S Giacomini, MD | Contact | 514-244-5060 | paul.giacomini@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Paul S Giacomini, MD | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Neurological Institute and Hospital | Recruiting | Montreal | Quebec | H3A 2B4 | Canada |
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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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000084542 | Eye-Tracking Technology |
| ID | Term |
|---|---|
| D053483 | Eye Movement Measurements |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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) | 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. | Baseline and Month 12 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004568 | Electrodiagnosis |