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

NCT06871800 | Recruiting

• 2 other identifiers: PRISMACET 65/24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stroke; Vascular Severe Brain Injury; Rehabilitation

Keywords

stroke; brain injury; biomarkers; biosensor; response to treatment

Outcome Measures

Primary Outcomes (1)

• Change in modified Barthel index after rehabilitation

  Modified Barthel index (Shah et al., 1989) validated in the literature and already proposed in the PMIC 2020 and PMGCA 2020 by SIMFER, will be used for accurate patient profiling and assessment of functional recovery (for all groups).

  From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)

Secondary Outcomes (8)

• Extracellular vesicles characterization by SPRi

  From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)

• Change in National Institute of Health Stroke Scale (NIHSS) (for stroke)

  From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)

• Change in Coma Recovery Scale (for vSBI)

  From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)

• Change in Level of Cognitive Functioning (LCF) (for vSBI)

  From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)

• Change in Glasgow Outcome Scale - Extended (GOSE) (for vSBI)

  From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)

Study Arms (2)

Stroke patients

30 post-stroke patients will be enrolled at IRCCS S. Maria Nascente (Milan), S. Maria ai Colli (Turin) and IRCCS Don Gnocchi (Florence) of Fondazione Don Gnocchi.

Other: blood withdrawal

Patients with vascular severe brain injury

30 patients with vascular severe brain injury (vSBI) will be enrolled at IRCCS S. Maria Nascente (Milan), and S. Maria ai Colli (Turin) of Fondazione Don Gnocchi.

Interventions

blood withdrawal OTHER

10 ml of blood, two 5 ml tubes suitable for serum isolation. Blood collection will be done at admission in the rehabilitation department (T0), after completing 50% of their rehabilitation program (T1), and at discharge (T2)

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at Fondazione Don Gnocchi (IRCCS S. Maria Nascente/Milan, S. Maria ai Colli/Turin, and IRCCS Don Gnocchi/Florence) after stroke injury or with vascular severe brain injury and undergoing an intensive rehabilitation program.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (3)

IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus

Florence, 50143, Italy

RECRUITING

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

Milan, 20148, Italy

RECRUITING

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

Torino, 10133, Italy

RECRUITING

Related Publications (4)

• Gualerzi A, Picciolini S, Roda F, Bedoni M. Extracellular Vesicles in Regeneration and Rehabilitation Recovery after Stroke. Biology (Basel). 2021 Aug 30;10(9):843. doi: 10.3390/biology10090843.

  PMID: 34571720 BACKGROUND

• Picciolini S, Gualerzi A, Carlomagno C, Cabinio M, Sorrentino S, Baglio F, Bedoni M. An SPRi-based biosensor pilot study: Analysis of multiple circulating extracellular vesicles and hippocampal volume in Alzheimer's disease. J Pharm Biomed Anal. 2021 Jan 5;192:113649. doi: 10.1016/j.jpba.2020.113649. Epub 2020 Sep 23.

  PMID: 33038641 BACKGROUND

• Picciolini S, Gualerzi A, Vanna R, Sguassero A, Gramatica F, Bedoni M, Masserini M, Morasso C. Detection and Characterization of Different Brain-Derived Subpopulations of Plasma Exosomes by Surface Plasmon Resonance Imaging. Anal Chem. 2018 Aug 7;90(15):8873-8880. doi: 10.1021/acs.analchem.8b00941. Epub 2018 Jul 17.

  PMID: 29972017 BACKGROUND

• Picciolini S, Mangolini V, Roda F, Montesano A, Arnaboldi F, Liuzzi P, Mannini A, Bedoni M, Gualerzi A. Multiplexing Biosensor for the Detection of Extracellular Vesicles as Biomarkers of Tissue Damage and Recovery after Ischemic Stroke. Int J Mol Sci. 2023 Apr 27;24(9):7937. doi: 10.3390/ijms24097937.

  PMID: 37175644 BACKGROUND

Related Links

• Laboratory of Nanomedicine and Clinical Biophotonics, Fondazione Don Carlo Gnocchi

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples used for extracellular vesicles isolation. DNA content will be not considered

MeSH Terms

Conditions

Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Alice Gualerzi, PhD

  Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Gualerzi, PhD

CONTACT

+390240308533; agualerzi@dongnocchi.it

Alessandro Viganò, MD, PhD

CONTACT

+390240308381; avigano@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: September 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)