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Related Experiment Video

Updated: Jun 16, 2026

Dynamic Digital Biomarkers of Motor and Cognitive Function in Parkinson's Disease
10:28

Dynamic Digital Biomarkers of Motor and Cognitive Function in Parkinson's Disease

Published on: July 24, 2019

Essential Tremor and Digital Biomarkers: A Scoping Review Using the TRACE Framework to Map Readiness for Clinical

David Ledingham1,2,3,4, Antonella Macerello5,6, Nicola Pavese1,2,3,7,4

  • 1Clinical Ageing Research Unit, Newcastle University, Campus for Ageing and Vitality, Newcastle upon Tyne, UK.

Tremor and Other Hyperkinetic Movements (New York, N.Y.)
|June 15, 2026
PubMed
Summary

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This summary is machine-generated.

Essential tremor digital biomarkers show basic clinical validity but lack readiness for trials. The TRACE framework reveals only two studies achieved clinical trial readiness, highlighting a translational gap.

Area of Science:

  • Neurology
  • Biomedical Engineering
  • Digital Health

Background:

  • Essential tremor (ET) is a common movement disorder with limited digital biomarker research.
  • A significant translational gap exists due to the lack of validated digital endpoints for ET therapies.
  • The TRACE (Technology Readiness And Clinical Evidence) framework is introduced to assess digital biomarker maturity.

Purpose of the Study:

  • To conduct a scoping review of digital biomarker research in essential tremor.
  • To apply the novel TRACE framework to evaluate the validation status of ET digital biomarkers.
  • To identify gaps in the development and validation of digital tremor outcome measures.

Main Methods:

  • A PRISMA-ScR scoping review of studies from 2000-2025 across four databases.
Keywords:
Clinical trialsDigital biomarkersEssential tremorScoping ReviewTRACE frameworkWearable sensors

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  • Inclusion criteria: quantitative digital tremor measurement in ≥10 ET participants.
  • Studies were categorized using the five-tier TRACE framework (T1-T5).
  • Main Results:

    • 165 studies were reviewed, utilizing modalities like wearables (n=114), handwriting (n=16), and computer vision (n=15).
    • 93% (154 studies) met Tier 2 (referenced clinical validity); 9 studies reached Tier 3, and 2 reached Tier 4 (Cala Health TAPS wristband).
    • Only 11 studies demonstrated ambulatory/longitudinal evidence beyond supervised validation; no studies reached Tier 5.

    Conclusions:

    • Most ET digital biomarkers achieve basic clinical validity but fall short of trial readiness.
    • The Cala Health TAPS wristband is the only platform to reach Tier 4 validation.
    • Further research is needed on home deployment, minimum detectable change, and patient-reported outcomes for digital tremor metrics to serve as reliable endpoints.