Clinical trial Recruiting at 3 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations3 sites (Florence and 2 other locations)
StatusRecruiting
StartedSeptember 9, 2024
Main results expectedJune 2025
Study endsDecember 2025
Registry record updatedMarch 12, 2025
Trial IDNCT06871800 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.