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Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. The Digital self-Assessment for Multiple sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and clinically validated remote monitoring platform for MS patients and clinicians. The correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30 subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test had a poor reproducibility and clinicians expressed the wish to measure a walking range rather than a walking speed. Even though vision is the main sense impacting all other tests, particularly when interacting with a mobile, visual tests are rarely performed in real life. A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).
The hypothesis is that systematic and prospective multi-dimensional data collection of MS disabilities through the DAMS mobile application will refine the quality and accuracy of both clinicians and patients' knowledge of the disease progression and will ultimately improve the current care of patients.
To test this assumption, the statistician will analyze:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Multiple Sclerosis | Experimental | Patients will perform one or two visits at 15 days interval. Patients will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits. |
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| Healthy volunteer | Active Comparator | Healthy volunteers will only perform one visit. Healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Assessment on mobile | Other | The digital assessment is composed on 4 tests:
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of DAMS 3 test measured with digital assessment versus MSFC measured with traditional tests. | Determine the diagnostic performance of DAMS 3 tests (not included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDDSS) score [0;7]) compared to the traditional tests (MSFC) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of DAMS 4 tests measured with digital assessment versus MSFC (with vision test) measured with traditional tests | Determine the diagnostic performance of DAMS 4 tests (included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDSS) score [0;7]) compared to the conventional MSFC + Sloan low contrast letter acuity test |
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Inclusion Criteria:
MS patients:
Healthy volunteers:
Non-Inclusion Criteria:
MS patients and Healthy volunteers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth MAILLART, MD | Pitié-Salpêtrière Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital le Bocage | Dijon | France | ||||
| Hôpital Saint-Phllibert |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 7, 2021 | |
| Reset | Jan 27, 2021 | |
| Release | Jun 24, 2021 | |
| Reset | Jul 13, 2021 | |
| Release | Jun 17, 2024 | |
| Reset | Oct 2, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2021 | Jan 27, 2021 | |||
| Jun 24, 2021 |
| 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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Patients will perform one or two visits at 15 days interval. Healthy volunteers will only perform one visit. Patients and healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits.
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| Day 0 |
| Diagnostic performance of DAMS 3 tests measured with digital assessment versus MSFC revised measured with traditional tests | Determine the diagnostic performance of DAMS 3 tests for the detection of MS patients in a population of healthy volunteers and MS patients (with EDSS score [0;7]) compared to a revised form of MSFC in which PASAT has been replaced by SDMT | Day 0 |
| Diagnostic performance of DAMS 4 test measured with digital assessment versus MSFC revised with vision test measured with traditional tests | Determine the diagnostic performance of DAMS 4 tests for the detection of MS patients in a population of healthy volunteers and MS patients (with EDSS score [0;7]) compared to a revised form of MSFC in which PASAT has been replaced by SDMT and SLCLAT added. | Day 0 |
| Correlation between DAMS 3 tests measured with digital assessment and MSFC measured with traditional tests | To assess correlation between DAMS 3 tests and MSFC in MS patients and healthy volunteers | Day 0 |
| Correlation between DAMS 3 tests measured with digital assessment and MSFC revised measured with traditional tests | To assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT in MS patients and healthy volunteers | Day 0 |
| Correlation between DAMS 4 tests measured with digital assessment and MSFC with vision test measured with traditional tests | To assess correlation between DAMS 4 tests and MSFC with vision test result in MS patients and healthy volunteers | Day 0 |
| Correlation between DAMS 3 tests measured with digital assessment and MSFC revised with vision test measured with traditional tests | o assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT with vision test result in MS patients and healthy volunteers | Day 0 |
| Compare scores of digital assessment versus scores of traditional tests | To compare the scores obtained with each DAMS' evaluation test [mobile walking test, coordination test, attention test, vision test ] to those obtained with traditional tests (T25FW, 9-HPT, PASAT, SDMT, SLCLAT) in MS patients and healthy volunteers | Day 0 |
| Compare scores of digital assessment at day 0 versus 15 days later | To assess the test-retest reliability of DAMS 3 and 4 tests during the study in MS patients with EDSS score [0;7] | Day 15 |
| Safety of Mobile assessment with the collect of all the adverse events | Day 15 |
| Lille |
| France |
| Hôpital La Timone Adulte | Marseille | France |
| Hôpital Gui de Chauliac | Montpellier | France |
| Hôpital Pasteur | Nice | France |
| Hôpital Pitié Salpêtrière | Paris | France |
| Hôpital Maison Blanche | Reims | France |
| Hôpital Saint Hélier | Rennes | France |
| Hôpital Charles Nicolle | Rouen | France |
| Hôpital Hautepierre | Strasbourg | France |
| Jul 13, 2021 |
| Jun 17, 2024 | Oct 2, 2024 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |