Decentralized seizure monitoring in adult epilepsy
An academic decentralized clinical trial in adult epilepsy, evaluating wearable-derived seizure markers alongside patient-reported events in an ambulatory setting, on the Vitruvian Shield platform.
Trial design
Observational decentralized study collecting continuous physiological signals from a multi-sensor wearable alongside electronic patient-reported seizure events and medication adherence, with structured periodic assessments delivered through the Vitruvian Shield ePRO module and clinician-side review of episodes on the platform dashboard.
- Indication
- Adult epilepsy
- Sponsor
- Investigator-initiated, academic
- Clinical site
- Pending Publication Authorisation
Platform modules deployed
The study uses the following Vitruvian Shield modules in production: EDC, eConsent, ePRO, RPM, AI Analytics. Each module operates within the same audit trail, consent record, and access-control surface, so the study team works against one platform rather than a stitched set of tools.
Study metrics
Data volume captured to date
Recruitment and retention
Preliminary signal quality
Principal investigator
Regulatory framing
Conducted under institutional ethics approval. Informed consent collected electronically through the Vitruvian Shield eConsent module. Data processed in accordance with EU GDPR. The protocol is registered under the identifier PT-EPI-DCT-002.
More on Neurology on Vitruvian Shield
See how Vitruvian Shield supports the full workflow for studies in this therapeutic area, from protocol design through remote monitoring.