Abstract Details

Title Clinical Evaluation of a Software Medical Device for the Self-Assessment of Patients Living with Multiple Sclerosis: Results of the MSCopilot Study

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-012

Objective To evaluate the ability of MSCopilot to discriminate patients with multiple sclerosis (PwMS) with Expanded Disability Status Scale (EDSS) score ranging from 0 to 7 from healthy controls (HC) versus Multiple Sclerosis Functional Composite (MSFC) and the correlation between MSCopilot and MSFC z-scores.

Background Assessing patients’ disability in MS requires to perform time-consuming and expensive batteries of tests at the hospital. MSCopilot is a software medical device designed for the self-assessment of PwMS, consisting of 4 tests: walking, dexterity, cognition and low contrast vision.

Design/Methods In this multi-center, open-label, randomized, case-control, crossover study, 141 PwMS and 76 HC paired for age, sex, body mass index (BMI) and education were enrolled. Participants performed standard {25-foot walk test (T25FW), 9-hole peg test (9HPT), paced auditory serial addition task (PASAT), symbol digit modalities test (SDMT), Sloan Low-contrast letter acuity test (SLCLAT)} and digital tests: {mobile walking test (MWT), mobile coordination tests (MCT), mobile attention tests (MAT), mobile vision tests (MVT)}.

Results 116 PwMS (61% female, 74% relapsing-remitting MS, 26% progressive MS) and 69 HC were analyzed. The discriminative power of MSCopilot, quantified using area under the receiver operating characteristic curve (AUC), was non-inferior to that of MSFC (0.92 and 0.89 respectively) with no significant differences (ΔAUC=0.03, p=0.3). MSCopilot and MSFC combined z-scores correctly discriminated PwMS and HC with 81% and 76% sensitivity respectively and 82% and 88% specificity respectively. Pearson’s correlation coefficients for MSCopilot and MSFC were as follows: MSCopilot vs MSFC: r=0.81, p< 0.001; MSCopilot vs revised MSFC (SDMT): r=0.83, p< 0.001; MSCopilot vs MSFC4 (SDMT, SLCLAT): r=0.85, p< 0.001.

Conclusions Non-inferiority of MSCopilot ability to discriminate PwMS from HC versus MSFC was demonstrated. Strong correlations between digital and standard scores were found. These results suggest that MSCopilot could be used in clinical practice for the monitoring of MS disability progression.

Authors/Disclosures
Elisabeth Maillart PRESENTER	No disclosure on file
Pierre Labauge, MD	Dr. Labauge has nothing to disclose.
Mikael Cohen (Hopital Pasteur)	Mikael Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen, Roche, Merck, Ad scientiam, Novartis, Alexion, BMS.
Adil Maarouf	Adil Maarouf has nothing to disclose.
Sandra Vukusic, MD (Hopital Neurologique Pierre Wertheimer)	The institution of Dr. Vukusic has received research support from Biogen. The institution of Dr. Vukusic has received research support from Janssen. The institution of Dr. Vukusic has received research support from Merck. The institution of Dr. Vukusic has received research support from Novartis. The institution of Dr. Vukusic has received research support from Roche.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Bertrand Bourre	Bertrand Bourre has nothing to disclose.
Thibault Moreau	Thibault Moreau has nothing to disclose.
Séverine Bieuvelet	Séverine Bieuvelet has received personal compensation for serving as an employee of Ad Scientiam.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Saad Zinai	Saad Zinai has received personal compensation for serving as an employee of AD Scientiam. Saad Zinai has stock in Ad Scientiam.
Ayman P. Tourbah (Department of Neurology University Hospital Raymond Poincaré)	No disclosure on file

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