Blood Extracellular Vesicles as Predictive Recovery Biomarker After Stroke and Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subarachnoid haemorrhage
Cerebral venous thrombosis
Other previous neurological or psychiatric conditions
Autoimmune diseases
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood withdrawal
Other intervention10 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)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Stroke patients1 intervention
Group B: Patients with vascular severe brain injury0 interventions
Trial outcomes
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).
Time frame
From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)Secondary outcomes
1
Extracellular vesicles characterization by SPRi
Changes in biomarkers expression associated to EVs (CD9, CD31, CD171, IB4, CD11b, IRISIN, CD15/CD66b) from serum, by SPRi biosensor. Changes between baseline (T0) and samples at T1 (15-20days after T0) and T2 (after rehabilitation, max 2 months) will be evaluated (for all groups).
Time frame
From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)2
Change in National Institute of Health Stroke Scale (NIHSS) (for stroke)
NIHSS scale (Brott et al. 1989) , validated in the literature and already proposed in the PMIC 2020 by SIMFER, will be used for accurate patient profiling and assessment of functional recovery . Changes between baseline (T0) and samples at T1 (15-20days after T0) and T2 (after rehabilitation, max 2 months) will be evaluated (for stroke).
Time frame
From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)3
Change in Coma Recovery Scale (for vSBI)
Coma Recovery Scale (Giacino \& Kalmar, 2004) validated in the literature and already proposed in the PMGCA 2020 by SIMFER, will be used for accurate patient profiling and assessment of functional recovery. Changes between baseline (T0) and samples at T1 (15-20days after T0) and T2 (after rehabilitation, max 2 months) will be evaluated (for vSBI).
Time frame
From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)4
Change in Level of Cognitive Functioning (LCF) (for vSBI)
Level of Cognitive Functioning (Francesco Lombardi, 2002) validated in the literature and already proposed in the PMGCA 2020 by SIMFER, will be used for accurate patient profiling and assessment of functional recovery. Changes between baseline (T0) and samples at T1 (15-20days after T0) and T2 (after rehabilitation, max 2 months) will be evaluated (for vSBI).
Time frame
From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)Sponsors and contacts
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Source ClinicalTrials.gov