Using blood extracellular vesicles to predict recovery 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
This study is trying to see if certain markers in blood can help predict how well people will recover after a stroke or serious brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 3 sites (Florence and 2 other locations) |
| Trial ID | NCT06871800 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the predictive capacity of biomarkers associated with blood-derived extracellular vesicles (EVs) for anticipating recovery in patients after stroke and vascular severe brain injury (vSBI). By utilizing an optimized Surface Plasmon Resonance imaging (SPRi) biosensor, the study will assess various cell-derived families of EVs to understand their role in neuroinflammation, neuronal regeneration, and angiogenesis. The research will also investigate the correlation between EV biomarkers and rehabilitation outcomes, as well as their potential to identify patients at risk for healthcare-associated infections. Blood samples will be collected from eligible patients to analyze these biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals with a first ischemic or hemorrhagic stroke or those requiring rehabilitation after vascular severe brain injury within specified timeframes.
Not a fit: Patients with subarachnoid hemorrhage, cerebral venous thrombosis, or other significant neurological or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide early objective biomarkers to better predict recovery trajectories for patients after stroke and brain injury.
How similar studies have performed: While the use of extracellular vesicles as biomarkers is a growing field, this specific approach to predicting recovery after stroke and brain injury is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Florence and 2 other locations
- IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus — Florence, Italy (Recruiting)
- IRCCS "S. Maria Nascente", Fondazione Don Gnocchi Onlus — Milan, Italy (Recruiting)
- "S. Maria ai Colli - Presidio Ausiliatrice", Fondazione Don Gnocchi Onlus — Torino, Italy (Recruiting)
Study contacts
- Principal investigator: Alice Gualerzi, PhD — Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics
- Study coordinator: Alice Gualerzi, PhD
- Email: agualerzi@dongnocchi.it
- Phone: +390240308533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.