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This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: MS Participants | Experimental | MS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks. |
|
| B: Healthy Controls | Other | Healthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone and Smartwatch | Device | Multiple sclerosis participants and healthy controls are required to wear the smartwatch; and to carry smartphone preferably in a median position in a belt bag, or alternatively in their pocket as they go about their daily routine. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks | Week 12 | |
| Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks | Week 24 | |
| Satisfaction Questionnaire Score at Week 12: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities | Week 12 | |
| Satisfaction Questionnaire Score at Week 24: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities | Week 24 |
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Inclusion Criteria:
For MS Participants:
For All Participants:
Exclusion Criteria:
For MS Participants:
For All Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF- Multiple Sclerosis Centre; Department of Neurology | San Francisco | California | CA94158 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37782540 | Derived | Graves JS, Elantkowski M, Zhang YP, Dondelinger F, Lipsmeier F, Bernasconi C, Montalban X, Midaglia L, Lindemann M. Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test. JMIR Form Res. 2023 Oct 2;7:e46521. doi: 10.2196/46521. | |
| 34259588 | Derived | Montalban X, Graves J, Midaglia L, Mulero P, Julian L, Baker M, Schadrack J, Gossens C, Ganzetti M, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M, Hauser SL. A smartphone sensor-based digital outcome assessment of multiple sclerosis. Mult Scler. 2022 Apr;28(4):654-664. doi: 10.1177/13524585211028561. Epub 2021 Jul 14. |
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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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| Hospital Vall d'Hebron; Servicio de NeurologĂa |
| Barcelona |
| 08035 |
| Spain |
| 31471961 | Derived | Midaglia L, Mulero P, Montalban X, Graves J, Hauser SL, Julian L, Baker M, Schadrack J, Gossens C, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study. J Med Internet Res. 2019 Aug 30;21(8):e14863. doi: 10.2196/14863. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |