NMOSDCopilot: Feasibility of Smartphone-Based Digital Biomarkers for the Self-Assessment of Vision, Motor and Cognitive Functions in Neuromyelitis Optica Spectrum Disorder
Michael Levy1, Elias Sortichos2, Hélène Zephir3, Julie Pique4, Loïc Carment5, Clarissa Gorin5, Sonia Kapche Kamga5, Dellini Ravindra5, Emma Touré Cuq5, Sami Fam6, Adrian Kielhorn6, Emrah Aras6, Jérôme De Sèze7
1Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, USA, 2Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, USA, 3Department of neurology, University of Lille, U Inserm 1172, CHU of Lille, France, 4Centre de référence des maladies inflammatoires rares du cerveau et de la moelle (MIRCEM), Service de neurologie, sclérose en plaques, Pathologies de la myéline et neuro-inflammation, Hôpital Neurologique Pierre Wertheimer Hospices Civils de Lyon, Lyon, France, 5Ad Scientiam, Paris, France, 6Alexion Pharmaceuticals Inc., Boston, MA 02210, USA, 7Department of Neurology, Hôpital Civil, Strasbourg University, Strasbourg, France
Objective:
To identify clinically relevant digital biomarkers (dBMKs) for the monitoring of patients with neuromyelitis optica spectrum disorder (NMOSD). To assess the feasibility of integrating these dBMKs into a software medical device intended to be used by patients as a self-assessment of disease burden tool.
Background:
NMOSD course is driven by episodes of severe, sequential relapses leading to the accrual of permanent disability. Multiple sclerosis (MS)-related instruments are often utilized for the assessment of NMOSD symptoms. However, NMOSD clinical presentation differs from MS, necessitating NMOSD-specific assessment instruments.
Design/Methods:
MSCopilot is a clinically validated software medical device that collects dBMKs for the self-assessment of patients with MS on their smartphones. We performed a feasibility study, based on interviews with NMOSD experts and patients to identify user-related needs and adaptations to be made on MSCopilot. Prototypes were used to define an appropriate digital device for the monitoring of NMOSD. Potential use-related errors were also investigated.
Results:
Interviews with NMOSD patients in France and the USA (n=19) revealed that the use of the four MSCopilot active tasks assessing cognitive, ambulatory, vision, and dexterity impairment was relevant for NMOSD, and identified additional features specific to NMOSD. Based on interviews with 8 international NMOSD experts, relevant dBMKs for patient self-monitoring were selected. The NMOSDCopilot device will include digital active measures of vision, walking, dexterity, and cognition function relying on the smartphone’s sensors. Patient-reported outcome measures assessing pain, fatigue, bladder and bowel functions, depression, and quality of life will also be included through digital questionnaires.
Conclusions:
Adapting MSCopilot into a digital self-assessment device for NMOSD was deemed feasible and usable by NMOSD clinical experts and patients. NMOSDCopilot will be developed and clinically validated in an international multicenter study in 2023. Its digital functional measures will be compared to clinical standards.