Clinical Applications of Digital Biomarkers in Multiple Sclerosis: A Systematic Literature Review
Bryan Cobb1, Richard J. Karpowicz, Jr2, Chris Cousin1, Nikki Win1, Tina Boggiano3, David E. Jones1, Licinio Craveiro3, Jessica Priest1, Ami Mac1, Edmond Teng1, E. Ray Dorsey4, Marwan N. Sabbagh5, Mark Gudesblatt6, Bart M. Demaerschalk7, David W. Dodick8
1Genentech Inc., 2Health Interactions, Inc., 3F. Hoffmann-La Roche Ltd, 4Center for Health + Technology and Department of Neurology, University of Rochester, 5Alzheimer's Clinical and Translational Research Lab, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, 6South Shore Neurologic Associates, 7Department of Neurology, Mayo Clinic College of Medicine and Science and Center for Digital Health, 8Department of Psychiatry and Psychology, Mayo Clinic School of Medicine, Mayo Clinic Arizona
Objective:
To evaluate current published literature reporting the clinical utility of digital biomarker measures for gait, voice and cognition in patients with multiple sclerosis (MS).
Background:
A substantial unmet need exists for more sensitive monitoring of MS manifestations and disease trajectories, especially early in the disease process. Digital solutions are emerging that are objective and more easily deployed than traditional measures, with the potential to better represent disease manifestations through multidimensional assessments; however, the maturity of these digital technologies remains unclear.
Design/Methods:
MEDLINE and Embase databases were systematically searched (January 2017 to April 2023) to identify studies that reported clinical applications of digital biomarkers for gait, voice and cognition in patients with MS. Publications in English with ≥50 participants were eligible for inclusion; publications describing studies of cognition were limited to those reporting remotely deployed technologies.
Results:
In total, 74 publications were identified for inclusion after second-level screening (gait, 51; voice, 6; cognition, 17). The number of publications per year increased for all digital solutions from 2017 to 2022 (gait, 5 to 13 publications; voice, 0 to 2; cognition, 0 to 6, respectively). The most commonly reported devices for gait, voice and cognition, respectively, were wearable sensors (27% of gait studies), microphones (83% of voice studies), and smartphones (94% of cognition studies). Digital biomarker results were compared with reference standards in most studies (gait, 86%; voice, 67%; cognition, 82%). Most gait (67%) and all voice studies collected data only in a clinical setting.
Conclusions:
The number of studies evaluating gait, voice and cognitive digital biomarkers to better phenotype and predict disease trajectories in patients with MS is increasing. Substantial opportunity to validate digital solutions in clinical practice remains, especially for those deployed remotely.