A smartphone sensor-based digital outcome assessment of multiple sclerosis.

BACKGROUND

Sensor-based monitoring tools fill a critical gap in multiple sclerosis (MS) research and clinical care.

OBJECTIVE

The aim of this study is to assess performance characteristics of the Floodlight Proof-of-Concept (PoC) app.

METHODS

In a 24-week study (clinicaltrials.gov: NCT02952911), smartphone-based active tests and passive monitoring assessed cognition (electronic Symbol Digit Modalities Test), upper extremity function (Pinching Test, Draw a Shape Test), and gait and balance (Static Balance Test, U-Turn Test, Walk Test, Passive Monitoring). Intraclass correlation coefficients (ICCs) and age- or sex-adjusted Spearman's rank correlation determined test-retest reliability and correlations with clinical and magnetic resonance imaging (MRI) outcome measures, respectively.

RESULTS

Seventy-six people with MS (PwMS) and 25 healthy controls were enrolled. In PwMS, ICCs were moderate-to-good (ICC(2,1) = 0.61-0.85) across tests. Correlations with domain-specific standard clinical disability measures were significant for all tests in the cognitive ( = 0.82, < 0.001), upper extremity function (|r|= 0.40-0.64, all < 0.001), and gait and balance domains ( = -0.25 to -0.52, all < 0.05; except for Static Balance Test: = -0.20, > 0.05). Most tests also correlated with Expanded Disability Status Scale, 29-item Multiple Sclerosis Impact Scale items or subscales, and/or normalized brain volume.

CONCLUSION

The Floodlight PoC app captures reliable and clinically relevant measures of functional impairment in MS, supporting its potential use in clinical research and practice.