NCT06871800 Blood Extracellular Vesicles as Predictive Recovery Biomarker After Stroke and Brain Injury
| NCT ID | NCT06871800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-09-09 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Contact & Investigator
Alice Gualerzi, PhD
PRINCIPAL INVESTIGATOR
Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics
Frequently Asked Questions
Who can join the NCT06871800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06871800 currently recruiting?
Yes, NCT06871800 is actively recruiting participants. Contact the research team at agualerzi@dongnocchi.it for enrollment information.
Where is the NCT06871800 trial being conducted?
This trial is being conducted at Florence, Italy, Milan, Italy, Torino, Italy.
Who is sponsoring the NCT06871800 clinical trial?
NCT06871800 is sponsored by Fondazione Don Carlo Gnocchi Onlus. The principal investigator is Alice Gualerzi, PhD at Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics. The trial plans to enroll 60 participants.
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