Extracellular Vesicles in Regeneration and Rehabilitation Recovery after Stroke.
Alice Gualerzi, Silvia Picciolini, Francesca Rodà...
https://pubmed.ncbi.nlm.nih.gov/34571720Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-03-12
60
Participants Needed
3
Research Sites
26 weeks
Total Duration
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
Blood Extracellular Vesicles as Predictive Recovery Biomarker After Stroke and Brain Injury
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
A
Alice Gualerzi, PhD
A
Alessandro Viganò, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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