Using blood extracellular vesicles to predict recovery after stroke and brain injury
Official title: Evaluation of Predictive Circulating Biomarkers for Rehabilitation Recovery in Ischemic and Haemorrhagic Stroke Patients: From Lacunar Stroke to Vascular Severe Brain Injury
Run by Fondazione Don Carlo Gnocchi ETS · NCT06871800 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 3 sites (Florence and 2 other locations) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | June 2025 |
| Study ends | December 2025 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06871800 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with subarachnoid hemorrhage, cerebral venous thrombosis, or other significant neurological or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
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Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
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In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.