Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2019-02-01
2022-09-30
Brief Summary
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Aim of the study was to evaluate the role of immunosuppression in the neurorehabilitation pathway in patients with stroke.
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Detailed Description
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In the acute phase, inflammatory mediators are responsible of central nervous system inflammation, associated to tissue repair at the expense of possible secondary brain injury or damage expansions.
In the mean time, activation of hypothalamic-pituitary-adrenal axis and the autonomic nervous system determine downregulation of innate and adaptive immunity, with decreased circulating T cell count and reduced lymphocytic response. The degree of these changes is linked to the severity of brain damage and inevitably lead to higher vulnerability to infections, representing a negative prognostic factor in the acute phase.
Association between immunosuppression and functional outcome in the neurorehabilitation setting are missing.
Aim of this study was to evaluate the role of immunosuppression in the neurorehabilitation journey in patients with stroke.
We analyzed the neutrophil-to-lymphocyte ratio, a useful tool to investigate alterations in both the innate and adaptive immune systems. We correlated it to clinical and neurorehabilitation scales, investigating disability, functional status, as well as gait analysis and occurrence of infectious complications. All outcomes were measured on admission in Neurorehabilitation setting and at hospital discharge.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Stroke patients with immunosuppression
Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio \>= 5 at hospital admission
Neurorehabilitation
Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
Stroke patients without immunosuppression
Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio \< 5 at hospital admission
Neurorehabilitation
Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
Interventions
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Neurorehabilitation
Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
Eligibility Criteria
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Inclusion Criteria
* admission to the Neurorehabilitation ward within 30 days from the index event
Exclusion Criteria
* immunosuppressive or immunomodulating therapy in the year before the index event
* systemic steroids in the six months before the index event
* Glasgow Coma Scale \< 8 at hospital admission
* other diagnosis of neurological diseases
* missing clinical/demographic data
18 Years
95 Years
ALL
No
Sponsors
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IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Responsible Party
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Locations
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Headache Science & Neurorehabilitation Center
Pavia, , Italy
Countries
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References
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Meisel C, Schwab JM, Prass K, Meisel A, Dirnagl U. Central nervous system injury-induced immune deficiency syndrome. Nat Rev Neurosci. 2005 Oct;6(10):775-86. doi: 10.1038/nrn1765.
Shi K, Wood K, Shi FD, Wang X, Liu Q. Stroke-induced immunosuppression and poststroke infection. Stroke Vasc Neurol. 2018 Jan 12;3(1):34-41. doi: 10.1136/svn-2017-000123. eCollection 2018 Mar.
Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.
Morotti A, Marini S, Jessel MJ, Schwab K, Kourkoulis C, Ayres AM, Gurol ME, Viswanathan A, Greenberg SM, Anderson CD, Goldstein JN, Rosand J. Lymphopenia, Infectious Complications, and Outcome in Spontaneous Intracerebral Hemorrhage. Neurocrit Care. 2017 Apr;26(2):160-166. doi: 10.1007/s12028-016-0367-2.
Wartenberg KE, Stoll A, Funk A, Meyer A, Schmidt JM, Berrouschot J. Infection after acute ischemic stroke: risk factors, biomarkers, and outcome. Stroke Res Treat. 2011;2011:830614. doi: 10.4061/2011/830614. Epub 2011 Jun 12.
Vaghi G, Morotti A, Piella EM, Avenali M, Martinelli D, Cristina S, Allena M, Grillo V, Corrado M, Bighiani F, Cammarota F, Antoniazzi A, Ferrari F, Mazzacane F, Cavallini A, Pichiecchio A, Rognone E, Martinis L, Correale L, Castiglia SF, Trabassi D, Serrao M, Tassorelli C, De Icco R. The role of stroke-induced immunosuppression as a predictor of functional outcome in the neurorehabilitation setting. Sci Rep. 2024 Apr 9;14(1):8320. doi: 10.1038/s41598-024-58562-1.
Other Identifiers
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NeuroLympho
Identifier Type: -
Identifier Source: org_study_id
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