Evaluation of Predictive Circulating Biomarkers for Rehabilitation Recovery in Ischemic and Haemorrhagic Stroke Patients: From Lacunar Stroke to Vascular Severe Brain Injury

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The rehabilitation outcome and recovery, in people after stroke or with vascular severe brain injury(vSBI), are difficult to predict. Moreover, the clinical management of patients during hospitalization is problematic due to complex clinical conditions and complications, e.g. healthcare-associated infections(HAIs). Today we still lack early objective biomarkers that could predict the patient's trajectory at admission. Extracellular vesicles are nanoparticles naturally released by cells in physiological and pathological conditions. As important actors of cellular communication between different organs and body districts, EVs are currently under investigation as an informative tool able to reflect the clinical conditions of patients. Using an optimized Surface Plasmon Resonance imaging (SPRi) based biosensor, 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. If successful, the project will 1) demonstrate the ability of the SPRi biosensor to reveal differences in the relative amount of specific cell-derived EV subpopulations and their molecular cargo during disease progression and rehabilitation-induced recovery, 2) verify the impact of HAI on patients' response, 3) perform a patient's stratification to personalize the rehabilitation protocol.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Disability deriving from first ischemic or haemorrhagic stroke detected by MRI or CT scan

• Time from stroke onset or rehabilitation admission less than 1 month (for stroke) 3 months (for vSBI)

• Need of inward rehabilitation

• Signed informed consent by patient or legal representative

Locations
Other Locations
Italy
IRCCS Don Gnocchi, Fondazione Don Gnocchi Onlus
RECRUITING
Florence
IRCCS S. Maria Nascente, Fondazione Don Gnocchi Onlus
RECRUITING
Milan
S. Maria ai Colli - Presidio Ausiliatrice, Fondazione Don Gnocchi Onlus
RECRUITING
Torino
Contact Information
Primary
Alice Gualerzi, PhD
agualerzi@dongnocchi.it
+390240308533
Backup
Alessandro Viganò, MD, PhD
avigano@dongnocchi.it
+390240308381
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Stroke patients
30 post-stroke patients will be enrolled at IRCCS S. Maria Nascente (Milan), S. Maria ai Colli (Turin) and IRCCS Don Gnocchi (Florence) of Fondazione Don Gnocchi.
Patients with vascular severe brain injury
30 patients with vascular severe brain injury (vSBI) will be enrolled at IRCCS S. Maria Nascente (Milan), and S. Maria ai Colli (Turin) of Fondazione Don Gnocchi.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus

This content was sourced from clinicaltrials.gov