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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 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. | Baseline and Month 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
are permitted)
For patients only:
Exclusion Criteria:
For healthy controls only:
For MS patients only
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Neuro | Recruiting | Montreal | Quebec | H3A 2B4 | Canada |
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| ID | Term |
|---|---|
| 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 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) | 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. | Baseline and Month 48 |
| Genge Partners, Inc. | Recruiting | Montreal | Quebec | H4A 3T4 | Canada |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004568 | Electrodiagnosis |