From Entropy to Outcome: Multimodal Digital Biomarkers in Stroke — NEURO-PERSIST Study Protocol (v0.5)

Universidad Independiente

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Abstract

NEURO-PERSIST is a pre-registered clinical study protocol for predicting 90-day functional outcome after ischemic or hemorrhagic stroke using interpretable multimodal digital biomarkers. The proposed biomarker domains include heart-rate-variability entropy, prosody stability, gait and motor microvariability, and baseline imaging/radiomics features. The protocol defines the modified Rankin Scale at 90 days (mRS-90d) as the primary outcome, analysed both ordinally and dichotomously (mRS 0-2 vs. 3-6). It introduces the Persistence Score C (PS_C), a replication-oriented feature robustness framework across centres, devices, time, and missingness. The planned sample size is N=300 with an assumed poor-outcome rate of…

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Topics & keywords

Keywords
  • Overfitting
  • Missing data
  • Clinical trial
  • Protocol (science)
  • Robustness (evolution)
  • Modified Rankin Scale
  • Inference
  • Sample size determination
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