StrokePRISMANCT06871800
Blood Extracellular Vesicles as Predictive Recovery Biomarker After Stroke and Brain Injury
An observational study of Stroke and Vascular Severe Brain Injury, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Vascular Severe Brain Injury, Rehabilitation
- What is being tested?
- blood withdrawal
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- 9 Sep 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS "Don Gnocchi", Fondazione Don Gnocchi Onlus
Florence, 50143
Francesca Cecchi, MD, +3905573931, fcecchi@dongnocchi.it
Francesca Cecchi
- Recruiting
IRCCS "S. Maria Nascente", Fondazione Don Gnocchi Onlus
Milan, 20148
Alice Gualerzi, PhD, +390240308533, agualerzi@dongnocchi.it
Alessandro Viganò, MD, PhD, +390240308381, avigano@dongnocchi.it
- Recruiting
"S. Maria ai Colli - Presidio Ausiliatrice", Fondazione Don Gnocchi Onlus
Torino, 10133
Annalisa Coppo, MD, acoppo@dongnocchi.it
Annalisa Coppo
About this study
Official title: Evaluation of Predictive Circulating Biomarkers for Rehabilitation Recovery in Ischemic and Haemorrhagic Stroke Patients: From Lacunar Stroke to Vascular Severe Brain Injury
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.
Read the detailed description
OBJECTIVE: The main objective of the present project is to assess the predictive capacity of biomarkers associated to extracellular vesicles (EVs) for anticipating patients' recovery after stroke and vSBI.
The characterization by SPRi of different cell-derived families of EVs (endothelium, neurons, microglia, muscle, and neutrophil) will allow to evaluate the activation status of the processes of neuroinflammation, neuronal regeneration, and angiogenesis to provide a picture of the mechanisms of response to the damage taking place in the brain of patients and enhanced by the rehabilitation treatment. The selected markers are expected to be released in the brain, but they can be monitored in the periphery taking advantage of the ability of EVs to cross the blood-brain barrier.
Due to the weight of HAIs on patients' prognosis, inflammation and infections will represent the main covariate of the analysis in the search for predictive rehabilitation biomarkers.
Specific objectives are as follows:
- Evaluation of the SPRi biosensor's ability to detect EV-associated biomarkers correlating with stroke severity.
- Evaluation of the ability of EV-associated biomarkers to represent a recovery biomarker by their changes according to the patient's outcome.
- Evaluation of the ability of EV-associated biomarkers to identify infection-prone patients to help develop valuable prevention strategies for infections.
These data will be correlated with the outcome of the rehabilitation evaluated with specific functional and neurological scales that allow accurate profiling of the patient and the evaluation of functional recovery.
IMPACT: The primary impact of the present project is the clinical management of the neurorehabilitation department for stroke and vSBI patients. The identification of measurable biomarkers that could predict the response to rehabilitation of patients and group them into responders or non-responders would significantly modify the everyday activity of physiatrists. In the long term, patients will take advantage of a personalized treatment that will lead to optimal recovery. Optimal intervention and recovery imply amelioration of the quality of life of patients and their families and reduced time and costs of the intervention.
SAMPLE COLLECTION: 30 stroke patients will be recruited at IRCCS S. Maria Nascente (Milan), S. Maria ai Colli (Turin), and IRCCS Don Gnocchi (Florence), while 30 subjects with vSBI will be recruited at IRCCS S. Maria Nascente (Milan) and S. Maria ai Colli (Turin) of Fondazione Don Gnocchi. Recruited patients will undergo blood withdrawal (10 ml of blood for serum separation) at 3 time points: at admission in the rehabilitation department (T0), after completing 50% of their rehabilitation program (T1), and at discharge (T2).
EV ISOLATION: EVs isolation will be perfomed at the Laboratory of Nanomedicine and Clinical Biophotonics of IRCCS S. Maria Nascente (Milan). EVs will be isolated from serum by size exclusion chromatography. To evaluate the size distribution and the concentration of the isolated EVs, the Nanoparticle Tracking Analysis (NTA) will be carried out. Reported markers of small EVs will be evaluated by Western blot to verify the successful isolation.
SPRi BIOSENSOR: The functionalization of the SPRi chip will be optimized for marker of endothelial EVs (CD31), neuronal EVs (CD171/L1CAM), microglia Evs (IB4), muscle EVs (Irisin), and neutrophil EVs (CD15 or CD66b).
Correlation analysis will be performed between SPRi-data and clinical measures at admission (T0), T1 and T2, separately. Correlation analysis will be performed also between the biomolecular markers measured at T0 and the change scores obtained from clinical assessments to test their ability to predict the outcome measure.
- Conditions
- Stroke, Vascular Severe Brain Injury, Rehabilitation
- Being tested
- blood withdrawal
- Keywords
- stroke, brain injury, biomarkers, biosensor, response to treatment
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood withdrawalOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Secondary outcomes (8)
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).
Measured: 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)
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).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
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).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
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).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Glasgow Outcome Scale - Extended (GOSE) (for vSBI)
Glasgow Outcome Scale Extended (J Neurotrauma, 1998) 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).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Rehabilitation Complexity Scale (for all groups)
Rehabilitation Complexity Scale (Lynne Turner-Stokes, 2007) 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 all groups).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Mini Mental State Evaluation (MMSE) (for stroke)
MMSE (T Nissen, 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.
Changes between baseline (T0) and samples at T1 (15-20days after T0) and T2 (after rehabilitation, max 2 months) will be evaluated (for stroke).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Modified RANKIN scale (mRS) (for all groups)
Modified RANKIN scale (G Popa, 1992) 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.
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).
Measured: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start9 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice Gualerzi, PhD, Principal investigator, Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871800
- Sponsor's protocol ID
- PRISMA
- Other IDs
- CET 65/24
- Acronym
- PRISMA
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personal data will be pseudoanonimized upon collection and reported in publications and scientific presentations only as anonymous and/or aggregated data that do not allow to trace the identity of the involved subjects.
Publications
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.
PubMed 34571720Picciolini 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.
PubMed 33038641Picciolini 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.
PubMed 29972017Picciolini 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.
PubMed 37175644
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Circulating Biomarkers for Rehabilitation Recovery in Ischemic and Haemorrhagic Stroke Patients: From Lacunar Stroke to Vascular Severe Brain Injury
- ClinicalTrials.gov ID
- NCT06871800
- Acronym / sponsor ID
- PRISMA / PRISMA
- Conditions
- Stroke, Vascular Severe Brain Injury, Rehabilitation
- Keywords
- stroke, brain injury, biomarkers, biosensor, response to treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVE: The main objective of the present project is to assess the predictive capacity of biomarkers associated to extracellular vesicles (EVs) for anticipating patients' recovery after stroke and vSBI.
The characterization by SPRi of different cell-derived families of EVs (endothelium, neurons, microglia, muscle, and neutrophil) will allow to evaluate the activation status of the processes of neuroinflammation, neuronal regeneration, and angiogenesis to provide a picture of the mechanisms of response to the damage taking place in the brain of patients and enhanced by the rehabilitation treatment. The selected markers are expected to be released in the brain, but they can be monitored in the periphery taking advantage of the ability of EVs to cross the blood-brain barrier.
Due to the weight of HAIs on patients' prognosis, inflammation and infections will represent the main covariate of the analysis in the search for predictive rehabilitation biomarkers.
Specific objectives are as follows:
- Evaluation of the SPRi biosensor's ability to detect EV-associated biomarkers correlating with stroke severity.
- Evaluation of the ability of EV-associated biomarkers to represent a recovery biomarker by their changes according to the patient's outcome.
- Evaluation of the ability of EV-associated biomarkers to identify infection-prone patients to help develop valuable prevention strategies for infections.
These data will be correlated with the outcome of the rehabilitation evaluated with specific functional and neurological scales that allow accurate profiling of the patient and the evaluation of functional recovery.
IMPACT: The primary impact of the present project is the clinical management of the neurorehabilitation department for stroke and vSBI patients. The identification of measurable biomarkers that could predict the response to rehabilitation of patients and group them into responders or non-responders would significantly modify the everyday activity of physiatrists. In the long term, patients will take advantage of a personalized treatment that will lead to optimal recovery. Optimal intervention and recovery imply amelioration of the quality of life of patients and their families and reduced time and costs of the intervention.
SAMPLE COLLECTION: 30 stroke patients will be recruited at IRCCS S. Maria Nascente (Milan), S. Maria ai Colli (Turin), and IRCCS Don Gnocchi (Florence), while 30 subjects with vSBI will be recruited at IRCCS S. Maria Nascente (Milan) and S. Maria ai Colli (Turin) of Fondazione Don Gnocchi. Recruited patients will undergo blood withdrawal (10 ml of blood for serum separation) at 3 time points: at admission in the rehabilitation department (T0), after completing 50% of their rehabilitation program (T1), and at discharge (T2).
EV ISOLATION: EVs isolation will be perfomed at the Laboratory of Nanomedicine and Clinical Biophotonics of IRCCS S. Maria Nascente (Milan). EVs will be isolated from serum by size exclusion chromatography. To evaluate the size distribution and the concentration of the isolated EVs, the Nanoparticle Tracking Analysis (NTA) will be carried out. Reported markers of small EVs will be evaluated by Western blot to verify the successful isolation.
SPRi BIOSENSOR: The functionalization of the SPRi chip will be optimized for marker of endothelial EVs (CD31), neuronal EVs (CD171/L1CAM), microglia Evs (IB4), muscle EVs (Irisin), and neutrophil EVs (CD15 or CD66b).
Correlation analysis will be performed between SPRi-data and clinical measures at admission (T0), T1 and T2, separately. Correlation analysis will be performed also between the biomolecular markers measured at T0 and the change scores obtained from clinical assessments to test their ability to predict the outcome measure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: blood withdrawal30 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Subarachnoid haemorrhage
- Cerebral venous thrombosis
- Other previous neurological or psychiatric conditions
- Autoimmune diseases
- Previous severe and chronic infections conditions (e.g. tuberculosis, HIV/AIDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood withdrawal10 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) | Other | Stroke patients |
Primary outcome
Change in modified Barthel index after rehabilitation
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
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).
8 secondary outcomes
Extracellular vesicles characterization by SPRi
Time frame: 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)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Coma Recovery Scale (for vSBI)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Level of Cognitive Functioning (LCF) (for vSBI)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Glasgow Outcome Scale - Extended (GOSE) (for vSBI)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Rehabilitation Complexity Scale (for all groups)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Mini Mental State Evaluation (MMSE) (for stroke)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Change in Modified RANKIN scale (mRS) (for all groups)
Time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 34571720Gualerzi 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.
- Background: PubMed 33038641Picciolini 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.
- Background: PubMed 29972017Picciolini 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.
- Background: PubMed 37175644Picciolini 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.
- Laboratory of Nanomedicine and Clinical Biophotonics, Fondazione Don Carlo GnocchiLink provided by the sponsor.
- Individual participant dataSharing planned: No. All personal data will be pseudoanonimized upon collection and reported in publications and scientific presentations only as anonymous and/or aggregated data that do not allow to trace the identity of the involved subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Gualerzi, PhD principal investigator
Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Vascular Severe Brain Injury, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Gualerzi, PhD (+390240308533, agualerzi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Barthel index after rehabilitation (time frame: From admission in the rehabilitation department (T0) to discharge (T2; max 2 months from enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06871800, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.