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Currently submitted to: Journal of Medical Internet Research

Date Submitted: Jul 9, 2026
Open Peer Review Period: Jul 10, 2026 - Sep 4, 2026
(currently open for review)
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Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

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

  • Frederik Steyn; 
  • Rakesh Pilkar; 
  • Nadia Sethi; 
  • Lori Heller; 
  • Cory Holdom; 
  • Ruben P.A. van Eijk; 
  • Marcin Straczkiewicz; 
  • Katherine M. Burke; 
  • James D. Berry; 
  • Sanjay Chandriani; 
  • Gordon Jewett; 
  • Emma Hodson-Tole; 
  • Collin Hovinga; 
  • Fernando Vieira; 
  • Christine Guo

ABSTRACT

Amyotrophic lateral sclerosis (ALS) clinical trials need outcome measures that complement established endpoints while capturing how people function in daily life. We synthesized stakeholder perspectives, patient input, and multisite actigraphy experiences to propose a roadmap for advancing actigraphy as a digitally derived clinical outcome measure in ALS. Priorities include patient-centered protocol design, harmonized data collection, fit-for-purpose validation, and staged adoption across observational research, clinical trials, industry, and regulatory contexts.


 Citation

Please cite as:

Steyn F, Pilkar R, Sethi N, Heller L, Holdom C, van Eijk RP, Straczkiewicz M, Burke KM, Berry JD, Chandriani S, Jewett G, Hodson-Tole E, Hovinga C, Vieira F, Guo C

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

JMIR Preprints. 09/07/2026:106677

DOI: 10.2196/preprints.106677

URL: https://preprints.jmir.org/preprint/106677

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