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“Evaluation of predictive circulating biomarkers for rehabilitation recovery in ischemic and haemorrhagic stroke patients: from lacunar stroke to vascular severe brain injury “

Bando per la valorizzazione della ricerca interna 2023
Duration: 21 months (01/07/2024 – 31/12/2025)

Within the framework of the 2022–2024 Strategic Research Plan, the Scientific Director of Fondazione Don Gnocchi promoted its first internal competitive call for proposals to fund innovative multidisciplinary projects in support of translational research, with a total allocation of €220,000, partly derived from the “5xMille 2022 – Health Research” funds.

The call was addressed to Fondazione Don Gnocchi researchers, with the aim of supporting innovative multidisciplinary projects, offering professional development pathways for early-career researchers, and investing in studies and analyses focused on proof of concept, as well as on the collection and validation of preliminary data useful for publication and for the future submission of national and international grant applications.

The PRISMA project, presented by Alice Gualerzi, was among the awarded projects, intended to stimulate collaboration among different research groups and between clinical and experimental areas (benchside and bedside), while also encouraging the development of new research fields.

Project overview

Stroke survivors and patients with vascular severe brain injury (vSBI) represent a rehabilitative challenge for healthcare professionals striving for maximizing rehabilitation outcome despite impactful disability, complex clinical conditions and complications occurring during hospitalization. Preliminary data demonstrate that healthcare-associated infections(HAIs) can negatively impact the rehabilitation outcome, but we are currently lacking early objective biomarkers that could predict at admission patients trajectory and recovery, besides clinical data. Our main objective is to assess the predictive capacity of biomarkers associated to blood derived extracellular vesicles for anticipating patients’ recovery after stroke and vSBI.

We will also verify the impact of HAI on patients’ response, the possibility to perform a patient’s stratification and to identify good responders before completing the rehabilitation protocol.

The results of this pilot study should lay the basis for a wider longitudinal study that could take into account different rehabilitation strategies and more specific objectives.

Consortium & Funding

PRISMA is coordinated by Dr. Alice Gualerzi (LABION) and it involves the collaboration of three clinical operative units of Fondazione Don Gnocchi:

  • NeRiM – IRCCS S. Maria Nascente, Milan
  • Promise@lab IRCCS Don Carlo Gnocchi, Florence
  • Centro santa maria ai colli, Turin

The project will be developed in centres of excellence for the management of people with stroke and vSBI. The UdR Nerim, led by Dr Viganò Alessandro first and by Dr. Angelo Bellinvia since July 2025, will be in charge in the patients’ clinical profiling, recruitment and the rehabilitation management.

The key collaborators of UdR2 have long lasting experience in the treatment of people after stroke and vSBI. and the involvement of other clinical research collaborators from Turin (Dr Coppo Annalisa) and Florence (Prof Cecchi Francesca) FDG Centers will contribute to reach the aims of the project from both a clinical and a technological point of view.

Impact

The impact of the present project is mainly on the clinical management of the neurorehabiliation department for stroke and vSBI patients. The identification of measurable biomarkers that could predict the response to rehabilitation of patients and group them in responders or non-responders would significantly modify the everyday activity of physiatrists. With a decision support tool like the proposed biosensor, they could start tailoring the rehabilitation program on patients’ need, hypothesize modifications in the rehabilitation protocol based on biomarkers that could be monitored during the hospitalization.

Main achievements

Currently, the main achievements of the PRISMA project can be summarized as follows:

  • definition of a recruitment protocol with the identification of shared and standardized timelines for the implementation of a longitudinal clinical data and biological sample collection protocol, useful for monitoring the rehabilitation pathway, while taking into account territorial differences in patient management
  • definition of a shared data collection database for stroke and vSBI patients, based on clinical information that is actually available for the selected cohort and without impact on routine clinical practice
  • identification of a procedure for the assessment of biomarkers correlated with the severity of the clinical condition, applicable to the selected patient cohort
  • collection of a uniform and shared database for the homogeneous clinical profiling of subjects recruited at the IRCCS S. Maria Nascente and IRCCS Don Gnocchi centers

Data analysis activities aimed at achieving the following objectives are still ongoing:

  • evaluation of the ability of EV-associated biomarkers to correlate with patient recovery after rehabilitative treatment (changes in the primary outcome)
  • assessment of the ability of EV-associated biomarkers to identify patient risk profiles for the development of infections

Dissemination activities

  • Poster Presentation “Extracellular Vesicles as biomarkers for rehabilitation recovery in stroke patients: the PRISMA study” – Nanoinnovation conference and exhibition 2025, Rome (IT), September 2025
  • “Science together “Biomarcatori predittivi del recupero post-ictus: risultati del progetto PRISMA” UdR LABION/NeRIM –  Science Together webinar organized by the Scientific Director of Fondazione Don Gnocchi, 30th September 2025