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This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial stage, participants are required to travel to the study site one day a week for three weeks to complete the MSFC. They are also required to complete the MSFC at home once weekly for three weeks using remote sensing technology and video conferencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 2. |
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| Group 2 | Active Comparator | Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Sclerosis Functional Composite | Procedure | The MSFC is a diagnostic test that measures multiple sclerosis symptoms. It includes a timed walk test, 9-hole peg test, and paced auditory serial addition test. The MSFC is administered in-person at the study site. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of mMSFC Tally | Safety of remote video administration of the mMSFC will be calculated at the end of the study by calculating and comparing the instances of balance-related safety issues. | Week 6 |
| MSFC Score Comparison | mMSFC scores will be compared to MSFC scores for proof of calibration. | Week 6 |
| Mobile Timed Walk Test Value Comparison | Mobile timed walk times will be compared to 25-foot timed walk test times for proof of calibration. | Week 6 |
| Mobile 9-hole Peg Test Time Comparison | Mobile 9HPT time will be compared to 9 HPT time for proof of calibration. | Week 6 |
| Mobile Paced Auditory Serial Addition Test Score Comparison | Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration. | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruthie Perez | Contact | ruthie.perez@mssm.edu | ||
| Tarah Gustafson | Contact | tarah.gustafson@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Sablinski, MD, PhD | Transparency Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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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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| Mobile Multiple Sclerosis Functional Composite | Procedure | The mMSFC is a diagnostic test that measures multiple sclerosis symptoms from. It includes a timed walk test, 9-hole peg test, and paced auditory serial addition test. All aspects of this exam are completed from a participant's home using remote sensing technology and video conferencing. |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |