Abstract Details

Title NMOSDCopilot: Feasibility of Smartphone-Based Digital Biomarkers for the Self-Assessment of Vision, Motor and Cognitive Functions in Neuromyelitis Optica Spectrum Disorder

Topic Autoimmune Neurology

Presentation(s) S50 - Autoimmune Neurology: NMOSD (3:42 PM-3:54 PM)

Poster/Presentation
Number 002

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.

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.

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.

Authors/Disclosures
Michael Levy, MD, PhD, FAAN (Massachusetts General Hospital/Harvard Medical School) PRESENTER	Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Pharma. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Levy has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Various law firms. The institution of Dr. Levy has received research support from National Institutes Health.
Elias S. Sotirchos, MD (Johns Hopkins University)	Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Sotirchos has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Sotirchos has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Sotirchos has received research support from National Institutes of Health. The institution of Dr. Sotirchos has received research support from National Multiple Sclerosis Society. The institution of Dr. Sotirchos has received research support from Sumaira Foundation. The institution of Dr. Sotirchos has received research support from Genentech. The institution of Dr. Sotirchos has received research support from UCB. The institution of Dr. Sotirchos has received research support from Astoria Biologica. The institution of Dr. Sotirchos has received research support from Ad Scientiam. The institution of Dr. Sotirchos has received research support from Alexion. The institution of Dr. Sotirchos has received research support from Corevitas. Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving as a Ad Hoc Reviewer with National Institutes of Health.
Helene Zephir (Hospital Roger Salengro)	Helene Zephir has received personal compensation in the range of $0-$499 for serving as a Consultant for BIogen Idec. Helene Zephir has received personal compensation in the range of $0-$499 for serving as a Consultant for novartis. Helene Zephir has received personal compensation in the range of $0-$499 for serving as a Consultant for BMS. Helene Zephir has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion.
	No disclosure on file
Loic Carment	No disclosure on file
Clarissa Gorin, Other (Ad Scientiam)	Dr. Gorin has received personal compensation for serving as an employee of Ad Scientiam.
	No disclosure on file
Dellini Ravindra (Ad Scientiam)	No disclosure on file
Emma Touré Cuq (Ad Scientiam)	No disclosure on file
Sami Fam	Sami Fam has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Sami Fam has stock in Astra Zeneca.
Adrian Kielhorn	Adrian Kielhorn has received personal compensation for serving as an employee of Alexion. Adrian Kielhorn has stock in Alexion.
Emrah Aras (Alexion Pharmaceuticals Inc.)	No disclosure on file
Jerome De Seze	Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma.