RecruitingNCT06871800

Blood Extracellular Vesicles as Predictive Recovery Biomarker After Stroke and Brain Injury

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


Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

60 participants

Start Date

Sep 9, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria7

  • Subarachnoid haemorrhage
  • Cerebral venous thrombosis
  • Other previous neurological or psychiatric conditions
  • Autoimmune diseases
  • Previous severe and chronic infections conditions (e.g. tuberculosis, HIV/AIDS)
  • Neoplasms or other malignant conditions
  • Immunomodulatory medications (immunosuppressants).

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Interventions

OTHERblood withdrawal

10 ml of blood, two 5 ml tubes suitable for serum isolation. Blood collection will be done at admission in the rehabilitation department (T0), after completing 50% of their rehabilitation program (T1), and at discharge (T2)


Locations(3)

IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus

Florence, Italy

IRCCS "S. Maria Nascente", Fondazione Don Gnocchi Onlus

Milan, Italy

"S. Maria ai Colli - Presidio Ausiliatrice", Fondazione Don Gnocchi Onlus

Torino, Italy

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NCT06871800


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