Actively Recruiting

Age: 18Years +
All Genders
ID06871800

Evaluation of Predictive Circulating Biomarkers for Rehabilitation Recovery in Stroke and Vascular Severe Brain Injury From Lacunar Stroke to Vascular Severe Brain Injury

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-03-12

60

Participants Needed

3

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of biomarkers found in blood-derived extracellular vesicles (EVs) to predict recovery outcomes in people who have had a stroke or vascular severe brain injury (vSBI). This study focuses on improving clinical management during rehabilitation by identifying early indicators that reflect brain damage, neuroinflammation, neuronal regeneration, and angiogenesis processes. The study also aims to understand how healthcare-associated infections impact patient recovery and to personalize rehabilitation protocols based on patient stratification. Participants include 30 stroke patients and 30 patients with vSBI recruited from specialized rehabilitation centers. Blood samples will be collected at three key points: admission to rehabilitation (T0), halfway through the rehabilitation program (T1), and at discharge (T2). Extracellular vesicles will be isolated and analyzed using an advanced Surface Plasmon Resonance imaging (SPRi) biosensor targeting EVs from different cell types such as endothelial cells, neurons, microglia, muscle, and neutrophils. This allows monitoring of molecular markers relevant to brain injury and recovery. During the study, patients will undergo blood withdrawals and clinical assessments using neurological and functional scales including the modified Barthel index, NIH Stroke Scale, Coma Recovery Scale, and others. The research team will correlate EV biomarker data with patient recovery progress from admission to discharge, typically within two months. The study aims to provide objective measures that could help predict rehabilitation outcomes and support personalized treatment plans to improve quality of life.

CONDITIONS

Brief Title

Blood Extracellular Vesicles as Predictive Recovery Biomarker After Stroke and Brain Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Disability resulting from a first ischemic or haemorrhagic stroke confirmed by MRI or CT scan
  • Time from stroke onset or rehabilitation admission less than 1 month for stroke, less than 3 months for vascular severe brain injury
  • Requirement for inpatient rehabilitation
  • Signed informed consent by the patient or legal representative
Not Eligible

You will not qualify if you...

  • Subarachnoid haemorrhage
  • Cerebral venous thrombosis
  • Previous neurological or psychiatric conditions
  • Autoimmune diseases
  • Severe and chronic infections such as tuberculosis or HIV/AIDS
  • Presence of neoplasms or other malignant conditions
  • Use of immunomodulatory medications such as immunosuppressants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 months

Participants undergo blood withdrawals to monitor extracellular vesicle biomarkers associated with recovery after stroke and brain injury. Blood samples are collected at admission, midway through rehabilitation, and at discharge to evaluate recovery progress.

3 visits (in-person) at admission, mid-rehabilitation, and discharge

Trial Site Locations

Total: 3 locations

1

IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus

Florence, Italy, 50143

Actively Recruiting

2

IRCCS "S. Maria Nascente", Fondazione Don Gnocchi Onlus

Milan, Italy, 20148

Actively Recruiting

3

"S. Maria ai Colli - Presidio Ausiliatrice", Fondazione Don Gnocchi Onlus

Torino, Italy, 10133

Actively Recruiting

Loading map...

Research Team

A

Alice Gualerzi, PhD

A

Alessandro Viganò, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

Efficacy and Target Engagement of a Digital Intervention to ...

Executive Dysfunction

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

An SPRi-based biosensor pilot study: Analysis of multiple circulating extracellular vesicles and hippocampal volume in Alzheimer's disease.

Silvia Picciolini, Alice Gualerzi, Cristiano Carlomagno...

https://pubmed.ncbi.nlm.nih.gov/33038641

Detection and Characterization of Different Brain-Derived Subpopulations of Plasma Exosomes by Surface Plasmon Resonance Imaging.

Silvia Picciolini, Alice Gualerzi, Renzo Vanna...

https://pubmed.ncbi.nlm.nih.gov/29972017

Multiplexing Biosensor for the Detection of Extracellular Vesicles as Biomarkers of Tissue Damage and Recovery after Ischemic Stroke.

Silvia Picciolini, Valentina Mangolini, Francesca Rodà...

https://pubmed.ncbi.nlm.nih.gov/37175644