NCT06871800Recruiting
Blood Extracellular Vesicles as Predictive Recovery Biomarker 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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 7 Mar 2025
- Start date
- 9 Sept 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT06871800
What you commit to
- Study type: Observational
- Planned participants: 60
- From 9 Sept 2024 to the primary completion date, Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other previous neurological or psychiatric conditions
- Previous severe and chronic infections conditions (e.g. tuberculosis, HIV/AIDS)
- Immunomodulatory medications (immunosuppressants).
Other illness
- Subarachnoid haemorrhage
- Cerebral venous thrombosis
- Autoimmune diseases
- Neoplasms or other malignant conditions
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS "S. Maria Nascente", Fondazione Don Gnocchi Onlus Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| "S. Maria ai Colli - Presidio Ausiliatrice", Fondazione Don Gnocchi Onlus Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.