Adult ADHD Digital Biomarker Feasibility Assessment: Charité Universitätsmedizin Berlin

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Bibliographische Detailangaben
1. Verfasser: Koroma, Martha Wuya
Format: Recurso digital
Sprache:Englisch
Veröffentlicht: Zenodo 2026
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author Koroma, Martha Wuya
author_facet Koroma, Martha Wuya
contents <p>There is no validated digital endpoint for adult ADHD in Europe. This document is a Phase II site feasibility assessment for a digital biomarker-aided diagnostic protocol at Charité Universitätsmedizin Berlin, targeting adult women with suspected or unrecognised ADHD and West African heritage. The proposed battery spans three evidence tiers: actigraphy and rest-activity rhythm (established, adult validation gap), continuous performance testing (validated, existing Charité infrastructure), and smartphone passive monitoring (novel, pilot-stage with large effect sizes). The framework includes community-anchored site feasibility, GDPR Article 9 privacy-by-design architecture, and EU MDR Class IIa regulatory pathway analysis.</p>
format Recurso digital
id zenodo_https___doi_org_10_5281_zenodo_20270533
institution Zenodo
language eng
publishDate 2026
publisher Zenodo
record_format zenodo
spellingShingle Adult ADHD Digital Biomarker Feasibility Assessment: Charité Universitätsmedizin Berlin
Koroma, Martha Wuya
Digital Biomarker
ADHD
Actigraphy
Smartphone/statistics & numerical data
Site Feasibility
Neurodevelopmental Disorders
GDPR
Charité Berlin
<p>There is no validated digital endpoint for adult ADHD in Europe. This document is a Phase II site feasibility assessment for a digital biomarker-aided diagnostic protocol at Charité Universitätsmedizin Berlin, targeting adult women with suspected or unrecognised ADHD and West African heritage. The proposed battery spans three evidence tiers: actigraphy and rest-activity rhythm (established, adult validation gap), continuous performance testing (validated, existing Charité infrastructure), and smartphone passive monitoring (novel, pilot-stage with large effect sizes). The framework includes community-anchored site feasibility, GDPR Article 9 privacy-by-design architecture, and EU MDR Class IIa regulatory pathway analysis.</p>
title Adult ADHD Digital Biomarker Feasibility Assessment: Charité Universitätsmedizin Berlin
topic Digital Biomarker
ADHD
Actigraphy
Smartphone/statistics & numerical data
Site Feasibility
Neurodevelopmental Disorders
GDPR
Charité Berlin
url https://doi.org/10.5281/zenodo.20270533