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The purpose of the study is to explore association patterns between digital outcome assessments from Konectom and MRI measures of brain tissue damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Konectom | Participants with a diagnosis of MS or clinically isolated syndrome who are enrolled in Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) and who own a smartphone model compatible with the Konectom platform will be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Konectom platform | Device | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage | Konectom tests include cognitive processing speed test (CPST), pinching test, drawing test, static balance test (SBT)/u-turn test (UTT) and 6-minute walking test (6MWT). | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Fluid-attenuated Inversion Recovery (FLAIR) Hyperintense MS Lesions Using 3D-T1 and 3D FLAIR Data | Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT. | Up to 1 year |
| Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Normal Appearing White Matter Using 3D-T1 and 3D FLAIR Data |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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The study population includes participants with a diagnosis of MS who are enrolled in MS PATHS.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Sclerosis Centre | Dresden | 01307 | Germany |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT. |
| Up to 1 year |
| Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Cortex Using 3D-T1 and 3D FLAIR Data | Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT. | Up to 1 year |
| Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Deep Grey Matter Using 3D-T1 and 3D FLAIR Data | Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT. | Up to 1 year |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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