Rethinking Digital Outcome Measures for Amyotrophic Lateral Sclerosis Trials: Consensus Priorities for Actigraphy Harmonization, Validation, and Regulatory Readiness

Frederik Steyn   ¹ , MSc, PhD ;   Rakesh Pilkar   ² , PhD ;   Nadia Sethi   ³ , DDS, MS ;   Lori Heller   ³ ;   Cory Holdom   ⁴ , PhD ;   Ruben P A van Eijk   ⁵ , MD, PhD ;   Marcin Straczkiewicz   ⁶ , PhD ;   Katherine M Burke   ⁷ , PT, DPT ;   James D Berry   ⁷ , MD, MPH ;   Sanjay Chandriani   ⁸ , PhD ;   Gordon Jewett   ⁹ , MD, MSc ;   Emma Hodson-Tole   ¹⁰ , MSc, PhD ;   Collin Hovinga   ¹¹ , PharmD, MS, FCCP ;   Fernando Vieira   ^{12 *} , MD ;   Christine Guo   ^{2 *} , PhD

¹ UQ Centre for MND Research, School of Biomedical Sciences, The University of Queensland, Brisbane, Queensland, Australia

² Ametris, Pensacola, FL, United States

³ North Star ALS, Santa Barbara, CA, United States

⁴ Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, England, United Kingdom

⁵ Department of Neurology & Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands

⁶ AGH University of Krakow, Krakow, Poland

⁷ Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA, United States

⁸ Trace Neuroscience, South San Francisco, CA, United States

⁹ Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada

¹⁰ Department of Life Science, Manchester Metropolitan University, Manchester, England, United Kingdom

¹¹ Critical Path Institute, Tucson, AZ, United States

¹² ALS Therapy Development Institute, Watertown, MA, United States

*these authors contributed equally