Early clinical studies

Work package (WP5)
Start Month:
13
End Month:
48
Lead Beneficiary:
UKE
Objectives:

The objective of this WP is to use the established prototype device for AxoSense from WP3 and protocol from WP4 and conduct a mechanistic study through an early clinical trial for data collection with stroke patients from the early stages post-stroke to the chronic stage.

Description:

Early clinical studies

Task 5.1:

Design and conduct the prospective clinical data collection study for biomarker evaluation on stroke patients

Task 5.2:

Clinical Review of eCRF and ePRO concepts with WP3

Task 5.3:

Clinical trial Coordination, Management, Safety and Data Management

Task 5.4:

Outline Clinical Investigation Plan (CIP) for identified biomarkers