Identifying Challenges to MSCopilot® 's Integration into Multiple Sclerosis Standard Clinical Practice: Methodology of MS-FLOWER, An Ongoing U.S. Multicenter Pilot Study
Leorah Freeman1, Gabriel Pardo2, Jenny Feng3, Theodore Brown4, Térence Brochu5, Loïc Carment5, Clarissa Gorin5, Lissandra Klaeylé5, Saad Zinaï5, Jennifer Graves6, Robert Naismith7
1Department of Neurology, Dell Medical School, The University of Texas at Austin, Austin, TX, USA, 2Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK 73104, USA; Multiple Sclerosis Center of Excellence, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA, 3The Desi Roth Harrison Center for Multiple Sclerosis, Ochsner Medical Center, New Orleans, LA, USA, 4EvergreenHealth Medical Center, Kirkland, WA, USA, 5Ad Scientiam, Paris, France, 6Department of Neurosciences, University of California, San Diego, CA, USA, 7Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA
Objective:
MS-FLOWER (NCT06922942) is a U.S. multicenter pilot study evaluating the feasibility, usability, and workflow integration of MSCopilot® in routine care, identifying optimization opportunities.
Background:
MSCopilot®, a clinically validated software-as-medical-device (SaMD), and its digital biomarkers measure key Multiple Sclerosis (MS) functions (walking, vision, cognition, and dexterity) enabling people MS (PwMS) to remotely assess symptom progression. While prior studies confirmed that MSCopilot® scores correlate with the Expanded Disability Status Scale (EDSS) and revised MS Functional Composite (MSFC) scores, integrating the tool into routine clinical practice remains challenging.
Design/Methods:
This 6-month prospective study follows PwMS and their HCPs. PwMS complete MSCopilot® monthly digital tests and self-reported questionnaires, Patient Health Questionnaire (PHQ-8) and Modified Fatigue Impact Scale-5 (MFIS-5) at home. HCPs review results through a dedicated web dashboard. User experience and satisfaction questionnaires evaluating HCP training, onboarding process, ease of use of MSCopilot® at-home and clinical workflows integration are administered to both patients and HCPs at baseline and months 1, 3 and 6.
Results:
Four U.S. MS centers, 8 MS specialists, additional nurses and healthcare providers participate in this study. Started in August 2025, a record 6-week enrollment registered 62 patients with EDSS ranging from 0-6.5. Study completion is projected for March 2026. Analyses will focus on the SaMD readiness, patient adherence, user experience/behaviour and the integration of the MSCopilot® app and dashboard into clinical workflows. Understanding workflow dynamics and technical support needs is critical for seamless at-home use of MSCopilot®, patients and HCPs’ onboarding, and integration into clinical practice. Interim results will be available for the annual meeting.
Conclusions:
Clinical integration of MSCopilot® could enhance disease monitoring, optimize clinical workflows, and improve patient engagement in Multiple Sclerosis management. This study paves the way for broader adoption of digital biomarkers in routine care, supporting personalized, data-driven management of PwMS in the U.S.
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