Actively Recruiting

Age: 18Years +
All Genders
NCT06871800

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

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-03-12

60

Participants Needed

3

Research Sites

64 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Disability from first ischemic or hemorrhagic stroke confirmed by MRI or CT scan
  • Stroke onset or rehabilitation admission less than 1 month ago for stroke patients
  • Stroke onset or rehabilitation admission less than 3 months ago for vascular severe brain injury patients
  • Need for inpatient rehabilitation
  • Signed informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • Subarachnoid hemorrhage
  • Cerebral venous thrombosis
  • Previous neurological or psychiatric conditions
  • Autoimmune diseases
  • Previous severe or chronic infections such as tuberculosis or HIV/AIDS
  • Cancer or other malignant conditions
  • Use of immunosuppressant medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus

Florence, Italy, 50143

Actively Recruiting

2

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

Milan, Italy, 20148

Actively Recruiting

3

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

Torino, Italy, 10133

Actively Recruiting

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Research Team

A

Alice Gualerzi, PhD

CONTACT

A

Alessandro Viganò, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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