StrokeEXO4STROKENCT05370105
Extracellular Vesicles as Stroke Biomarkers
An observational study of Stroke and Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
Trial summary
The combination of rehabilitation protocols and regenerative therapies offers the outstanding opportunity to promote and enhance the endogenous regenerative and repair processes occurring in tissues damaged or lost due to injury, disease, or age. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- blood withdrawal
- How many people
- 88 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Jun 2018to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients hospitalized at Fondazione Don Gnocchi after stroke injury and undergoing an intensive rehabilitation program.
Who may be able to join
- Diagnosis of ischemic or haemorrhagic stroke related to intensive post-stroke rehabilitation hospitalization
- within 15 days of the ictal event
Who cannot join
- Previous head injuries/traumas
- Oncological diseases
- Diseases of the immune and haematological system
- Neurodegenerative diseases
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Don Gnocchi, Fondazione Don Carlo Gnocchi ONLUS
Florence
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
Milan, 20148
About this study
Official title: Characterization of Circulating Extracellular Vesicles/Exosomes as New Predictive Biomarkers in Stroke Patients
The combination of rehabilitation protocols and regenerative therapies offers the outstanding opportunity to promote and enhance the endogenous regenerative and repair processes occurring in tissues damaged or lost due to injury, disease, or age. Still, one of the main hurdles in the clinical approach to regenerative rehabilitation is the lack of easily accessible and sensitive biomarkers for the evaluation of rehabilitation and therapy efficacy. Extracellular vesicles (EVs) are nanoscaled vesicles that mediate intercellular communication among organs. EVs were shown to be involved in the onset, progression and resolution of many disorders, being also used as valuable tool in the regenerative medicine field. However, the initial enthusiastic approach to EVs has been hindered in its transfer to clinics because of technological obstacles related to their dimensions and to their limited amount. The present project proposes the application of a Surface Plasmon Resonance imaging (SPRi)-based biosensor for the detection and characterization of blood EVs from stroke patients, before and after rehabilitation. After the successful SPRi detection of EVs of different cellular origin (brain and non-brain cells), the quantification of specific surface molecules related to pathological or regeneration processes will be accomplished. 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 in their cargo during disease progression and rehabilitation induced recovery, 2) provide support for using the proposed SPRi-based biosensor for the detection and characterization of circulating EVs in order to evaluate the efficacy of rehabilitation protocols and regenerative therapies, 3) identify new biomarkers for the profiling of stroke patients to personalize the rehabilitation therapies.
Read the detailed description
OBJECTIVE: The aim of the project will be the evaluation of the prognostic power of circulating extracellular vesicles (EVs) in the serum of stroke patients. The characterization by SPRi of different families of EVs will allow to evaluate the activation status of the processes of neuroinflammation, neuronal regeneration, angiogenesis and cellular damage to provide a picture of the mechanisms of response to the damage taking place in the patient. These data will be correlated with emerging prognostic markers derived from the literature (Gandolfi et al, 2017) and 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, according to what recently validated in the "Minimum rehabilitation evaluation protocol of the person with Cerebral Stroke Version 2020 - PMIC 2020" by the Italian Society of Physical and Rehabilitative Medicine (SIMFER) (https://springerhealthcare.it/mr/numero/volume-34-n- 2-June-2020 /).
The PMIC 2020 aims to provide each physiatrist / Rehabilitation Team with a uniform tool for the assessment of the person with stroke in the different phases of the disease, from acute hospital to territorial rehabilitation.
Specific objectives will be:
- optimization of the SPRi method for the identification of different families of EVs in the serum of healthy subjects; ii) evaluation of the feasibility of the SPRi based method for the characterization of EVs from the serum of stroke patients; iii) preliminary study of the correlation between SPRi data, soluble markers of inflammation and regeneration, patient profiling and rehabilitation outcome at discharge.
IMPACT: The personalization of the rehabilitation plan in relation to the injury suffered and the patient's active response would lead to an increased probability of functional recovery, with benefits in terms of quality of life for the patient and family members, and a reduction in the management costs of the for the National Health System.
SAMPLE COLLECTION: 80 post-stroke patients will be asked to undergo three samples of biological material (10 ml of blood, two 5 ml tubes suitable for serum isolation): the first collection on the second day of hospitalization (t0) at IRCCS S. Maria Nascente (Mialno) or IRCCS Don Gnocchi (Florence) of Fondazioen Don Gnocchi; a second withdrawal at discharge (t1), or approximately 2 months after the first withdrawal. Where possible, a third sampling (t2 - follow up) will be performed 6 months after the event at the IRCCS S. Maria Nascente or at the IRCCS in Florence. 20 healthy subjects will be asked to undergo a single sample of biological material (10 ml of blood, two 5 ml tubes suitable for serum isolation).
EV ISOLATION: The blood sample will be processed for serum separation. The samples will be coded, sterile aliquoted and stored at -80°C at the Laboratory of Nanomedicine and Clinical Biophotonics of IRCCS S. Maria Nascente (Milan) until used.
EVs will be isolated from serum by size exclusion chromatography (qEV; Izon). The actual isolation will be verified with standard techniques, including for example western blot for specific protein markers (CD63, Flotillin 1), Nanoparticle Tracking Analysis or Transmission Electron Microscopy.
SPRi BIOSENSOR: The functionalization of the SPRi chip will be optimized for known markers of apoptotic bodies (Annexin V; index of extent of brain damage) and of EVs from neurons (Ephrin), microglia (IB4 or CD11b), astrocytes (GLAST) and endothelial cells ( CD31). The chip will be also functionalized for the recognition of the Klotho protein (Sahu et al, 2018).
Immobilized EVs will be tested also for the presence on the surface of receptors related to neuronal regeneration (TGFbR1 / 2), microglial activation (TSPO) and angiogenesis (VEGFR-2).
RAMAN ANALYSIS: EVs isolated from patient serum will also be analyzed by Raman spectroscopy according to a protocol already optimized for patients with Parkinson's disease(Gualerzi et al., 2019). Raman analysis will provide information on the biochemical characteristics of the EVs, which can be correlated with the molecular data obtained in SPRi.
ELISA: known markers of inflammation and neuronal activation will be quantified in serum by ELISA assays: inflammatory cytokines (IL6 and TNFa), adipokines (leptin), soluble adhesion molecules (sICAM, sFAS) and growth factors (BDNF).
Correlation between SPRi data, soluble inflammatory and neurotrophic factors will be performed to identify new rehabilitation markers for stroke patients
- Conditions
- Stroke, Rehabilitation
- Being tested
- blood withdrawal
- Keywords
- brain remodeling, extracellular vesicles, biosensor, biophotonics, rehabilitation markers, regeneration, neuroinflammation, stroke biomarkers
- Medical subject headings
- Stroke, Neuroinflammatory Diseases
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. Given the nature and objectives of the study, there are no risks and / o inconveniences of particular importance for the patient since the blood samples will be performed according to the common procedure used in all analysis laboratories. At the end of the collection, in the area where the blood sample was taken, a small bruise may form which will disappear in the following hours, in any case during the collection particular attention will be paid to the subjects being treated with antiplatelet and anticoagulants.
The study does not include the execution of interventional treatments or therapies.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | 80 post-stroke patients will be asked to undergo three samples of biological material (10 ml of blood): the first collection on the second day of hospitalization at IRCCS S. Maria Nascente (Milano) or at IRCCS Don Gnocchi (Florence) of Fondazioen Don Gnocchi (t0) and a second withdrawal at discharge (t1), or approximately 2 months after the first withdrawal. Where possible, a third sampling (t2 - follow up) will be performed 6 months after the event. Receives: Other: blood withdrawal | |
| Healthy Controls | The healthy controls will be volunteers recruited at Fondazione Don Gnocchi, who are not affected by neurodegenerative and cardiovascular diseases and who have not taken anti-inflammatory drugs in the week prior to recruitment. Receives: Other: blood withdrawal |
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)
Measured: 01/11/2020 - 30/03/2022
Secondary outcomes (11)
Extracellular vesicles characterization by SPRi
EVs will be isolated from serum, characterized by standard procedures and injected on the SPRi biosensor for the differential quantification of multiple EV subfamilies. Secondary antigens will be evaluated on the surface of immobilized EVs.
Changes in biomarkers expression will be assessed after rehabilitation
Measured: 25/06/2018 - 30/09/2022
Change in Numeric Rating Scale (NRS) PAIN or PAINAD for non-verbal patient after rehabilitation
Numeric Rating Scale (NRS) PAIN or PAINAD for non-verbal patient, 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.
Measured: 25/06/2018 - 30/09/2022
Change in anamnestic and current modified RANKIN scale after rehabilitation
anamnestic and current modified RANKIN scale, 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.
Measured: 25/06/2018 - 30/09/2022
Change in NIH-STROKE SCALE after rehabilitation
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.
Measured: 25/06/2018 - 30/09/2022
Change in Fugl-Meyer Assessment (FMA) scale after rehabilitation
Fugl-Meyer Assessment (FMA) scale (Fugl-Meyer et al., 1975; Cecchi et al., 2020) , 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.
Measured: 25/06/2018 - 30/09/2022
Change in Trunk control test after rehabilitation
Trunk control test (Franchignoni et al, 1997), 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.
Measured: 25/06/2018 - 30/09/2022
Change in Short Physical Performance Battery (SPPB) after rehabilitation
SPPB (Guralnik et al, 1994) , 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.
Measured: 25/06/2018 - 30/09/2022
Change in Functional ambulation classification
Functional ambulation classification (Jan Mehrholz et al., 2007), 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.
Measured: 25/06/2018 - 30/09/2022
Change in Addenbrooke's Cognitive Examination scale after rehabilitation
Addenbrooke's Cognitive Examination (Mathuranath et al., 2000), 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.
Measured: 25/06/2018 - 30/09/2022
Change in Hospital Anxiety and Depression Scale (HADS) after rehabilitation
HADS, 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.
Measured: 25/06/2018 - 30/09/2022
Change in Cumulative illness rating scale (CIRS) after rehabilitation
CIRS (Linn et al., 1968), 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.
Measured: 25/06/2018 - 30/09/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start25 Jun 2018
- Primary completion30 Sep 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
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
- NCT05370105
- Sponsor's protocol ID
- EXO4STROKE
- Acronym
- EXO4STROKE
- Status last verified
- Jan 2025
- First submitted
- 22 Mar 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29972017Gualerzi A, Picciolini S, Carlomagno C, Terenzi F, Ramat S, Sorbi S, Bedoni M. Raman profiling of circulating extracellular vesicles for the stratification of Parkinson's patients. Nanomedicine. 2019 Nov;22:102097. doi: 10.1016/j.nano.2019.102097. Epub 2019 Oct 21.
PubMed 31648040Picciolini 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 33038641Gualerzi A, Picciolini S, Carlomagno C, Roda F, Bedoni M. Biophotonics for diagnostic detection of extracellular vesicles. Adv Drug Deliv Rev. 2021 Jul;174:229-249. doi: 10.1016/j.addr.2021.04.014. Epub 2021 Apr 19.
PubMed 33887403Gualerzi 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, 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Circulating Extracellular Vesicles/Exosomes as New Predictive Biomarkers in Stroke Patients
- ClinicalTrials.gov ID
- NCT05370105
- Acronym / sponsor ID
- EXO4STROKE / EXO4STROKE
- Conditions
- Stroke, Rehabilitation
- Keywords
- brain remodeling, extracellular vesicles, biosensor, biophotonics, rehabilitation markers, regeneration, neuroinflammation, stroke biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 May 2022 (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 combination of rehabilitation protocols and regenerative therapies offers the outstanding opportunity to promote and enhance the endogenous regenerative and repair processes occurring in tissues damaged or lost due to injury, disease, or age. Still, one of the main hurdles in the clinical approach to regenerative rehabilitation is the lack of easily accessible and sensitive biomarkers for the evaluation of rehabilitation and therapy efficacy. Extracellular vesicles (EVs) are nanoscaled vesicles that mediate intercellular communication among organs. EVs were shown to be involved in the onset, progression and resolution of many disorders, being also used as valuable tool in the regenerative medicine field. However, the initial enthusiastic approach to EVs has been hindered in its transfer to clinics because of technological obstacles related to their dimensions and to their limited amount. The present project proposes the application of a Surface Plasmon Resonance imaging (SPRi)-based biosensor for the detection and characterization of blood EVs from stroke patients, before and after rehabilitation. After the successful SPRi detection of EVs of different cellular origin (brain and non-brain cells), the quantification of specific surface molecules related to pathological or regeneration processes will be accomplished. 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 in their cargo during disease progression and rehabilitation induced recovery, 2) provide support for using the proposed SPRi-based biosensor for the detection and characterization of circulating EVs in order to evaluate the efficacy of rehabilitation protocols and regenerative therapies, 3) identify new biomarkers for the profiling of stroke patients to personalize the rehabilitation therapies.
Detailed description
OBJECTIVE: The aim of the project will be the evaluation of the prognostic power of circulating extracellular vesicles (EVs) in the serum of stroke patients. The characterization by SPRi of different families of EVs will allow to evaluate the activation status of the processes of neuroinflammation, neuronal regeneration, angiogenesis and cellular damage to provide a picture of the mechanisms of response to the damage taking place in the patient. These data will be correlated with emerging prognostic markers derived from the literature (Gandolfi et al, 2017) and 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, according to what recently validated in the "Minimum rehabilitation evaluation protocol of the person with Cerebral Stroke Version 2020 - PMIC 2020" by the Italian Society of Physical and Rehabilitative Medicine (SIMFER) (https://springerhealthcare.it/mr/numero/volume-34-n- 2-June-2020 /).
The PMIC 2020 aims to provide each physiatrist / Rehabilitation Team with a uniform tool for the assessment of the person with stroke in the different phases of the disease, from acute hospital to territorial rehabilitation.
Specific objectives will be:
- optimization of the SPRi method for the identification of different families of EVs in the serum of healthy subjects; ii) evaluation of the feasibility of the SPRi based method for the characterization of EVs from the serum of stroke patients; iii) preliminary study of the correlation between SPRi data, soluble markers of inflammation and regeneration, patient profiling and rehabilitation outcome at discharge.
IMPACT: The personalization of the rehabilitation plan in relation to the injury suffered and the patient's active response would lead to an increased probability of functional recovery, with benefits in terms of quality of life for the patient and family members, and a reduction in the management costs of the for the National Health System.
SAMPLE COLLECTION: 80 post-stroke patients will be asked to undergo three samples of biological material (10 ml of blood, two 5 ml tubes suitable for serum isolation): the first collection on the second day of hospitalization (t0) at IRCCS S. Maria Nascente (Mialno) or IRCCS Don Gnocchi (Florence) of Fondazioen Don Gnocchi; a second withdrawal at discharge (t1), or approximately 2 months after the first withdrawal. Where possible, a third sampling (t2 - follow up) will be performed 6 months after the event at the IRCCS S. Maria Nascente or at the IRCCS in Florence. 20 healthy subjects will be asked to undergo a single sample of biological material (10 ml of blood, two 5 ml tubes suitable for serum isolation).
EV ISOLATION: The blood sample will be processed for serum separation. The samples will be coded, sterile aliquoted and stored at -80°C at the Laboratory of Nanomedicine and Clinical Biophotonics of IRCCS S. Maria Nascente (Milan) until used.
EVs will be isolated from serum by size exclusion chromatography (qEV; Izon). The actual isolation will be verified with standard techniques, including for example western blot for specific protein markers (CD63, Flotillin 1), Nanoparticle Tracking Analysis or Transmission Electron Microscopy.
SPRi BIOSENSOR: The functionalization of the SPRi chip will be optimized for known markers of apoptotic bodies (Annexin V; index of extent of brain damage) and of EVs from neurons (Ephrin), microglia (IB4 or CD11b), astrocytes (GLAST) and endothelial cells ( CD31). The chip will be also functionalized for the recognition of the Klotho protein (Sahu et al, 2018).
Immobilized EVs will be tested also for the presence on the surface of receptors related to neuronal regeneration (TGFbR1 / 2), microglial activation (TSPO) and angiogenesis (VEGFR-2).
RAMAN ANALYSIS: EVs isolated from patient serum will also be analyzed by Raman spectroscopy according to a protocol already optimized for patients with Parkinson's disease(Gualerzi et al., 2019). Raman analysis will provide information on the biochemical characteristics of the EVs, which can be correlated with the molecular data obtained in SPRi.
ELISA: known markers of inflammation and neuronal activation will be quantified in serum by ELISA assays: inflammatory cytokines (IL6 and TNFa), adipokines (leptin), soluble adhesion molecules (sICAM, sFAS) and growth factors (BDNF).
Correlation between SPRi data, soluble inflammatory and neurotrophic factors will be performed to identify new rehabilitation markers for stroke patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: blood withdrawal80 post-stroke patients will be asked to undergo three samples of biological material (10 ml of blood): the first collection on the second day of hospitalization at IRCCS S. Maria Nascente (Milano) or at IRCCS Don Gnocchi (Florence) of Fondazioen Don Gnocchi (t0) and a second withdrawal at discharge (t1), or approximately 2 months after the first withdrawal. Where possible, a third sampling (t2 - follow up) will be performed 6 months after the event. |
| Healthy Controls | – | Other: blood withdrawalThe healthy controls will be volunteers recruited at Fondazione Don Gnocchi, who are not affected by neurodegenerative and cardiovascular diseases and who have not taken anti-inflammatory drugs in the week prior to recruitment. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at Fondazione Don Gnocchi after stroke injury and undergoing an intensive rehabilitation program.
Key inclusion criteria (2 listed)
- Diagnosis of ischemic or haemorrhagic stroke related to intensive post-stroke rehabilitation hospitalization
- within 15 days of the ictal event
Key exclusion criteria (4 listed)
- Previous head injuries/traumas
- Oncological diseases
- Diseases of the immune and haematological system
- Neurodegenerative diseases
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. Given the nature and objectives of the study, there are no risks and / o inconveniences of particular importance for the patient since the blood samples will be performed according to the common procedure used in all analysis laboratories. At the end of the collection, in the area where the blood sample was taken, a small bruise may form which will disappear in the following hours, in any case during the collection particular attention will be paid to the subjects being treated with antiplatelet and anticoagulants. The study does not include the execution of interventional treatments or therapies. | Other | Healthy Controls, Stroke patients |
Primary outcome
Change in modified Barthel index after rehabilitation
Time frame: 01/11/2020 - 30/03/2022
modified Barthel index (Shah et al., 1989)
11 secondary outcomes
Extracellular vesicles characterization by SPRi
Time frame: 25/06/2018 - 30/09/2022
Change in Numeric Rating Scale (NRS) PAIN or PAINAD for non-verbal patient after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in anamnestic and current modified RANKIN scale after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in NIH-STROKE SCALE after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in Fugl-Meyer Assessment (FMA) scale after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in Trunk control test after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in Short Physical Performance Battery (SPPB) after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in Functional ambulation classification
Time frame: 25/06/2018 - 30/09/2022
Change in Addenbrooke's Cognitive Examination scale after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in Hospital Anxiety and Depression Scale (HADS) after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Change in Cumulative illness rating scale (CIRS) after rehabilitation
Time frame: 25/06/2018 - 30/09/2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- 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 31648040Gualerzi A, Picciolini S, Carlomagno C, Terenzi F, Ramat S, Sorbi S, Bedoni M. Raman profiling of circulating extracellular vesicles for the stratification of Parkinson's patients. Nanomedicine. 2019 Nov;22:102097. doi: 10.1016/j.nano.2019.102097. Epub 2019 Oct 21.
- 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 33887403Gualerzi A, Picciolini S, Carlomagno C, Roda F, Bedoni M. Biophotonics for diagnostic detection of extracellular vesicles. Adv Drug Deliv Rev. 2021 Jul;174:229-249. doi: 10.1016/j.addr.2021.04.014. Epub 2021 Apr 19.
- 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.
- Results publication: 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: Undecided
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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. This study is not recruiting at the moment.
Alice Gualerzi, PhD principal investigator
Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics
2 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 Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 2 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Barthel index after rehabilitation (time frame: 01/11/2020 - 30/03/2022). 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 NCT05370105, which also lists 6 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 3 Feb 2025.