Stroke-induced Immunodepression in Neurorehabilitation

NCT ID: NCT05889169

Last Updated: 2023-06-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-09-30

Brief Summary

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The close interconnection between nervous system and the immune system is well known. Brain injuries lead to homeostasis disruption. On the one hand they result in increased brain inflammation contributing to tissue repair, at the expense of a possible extension of tissue damage. On the other hand, they lead to systemic down-regulation of innate and adaptive immunity, determining higher vulnerability to infections, responsible of death and comorbidities in the acute and subacute setting.

Aim of the study was to evaluate the role of immunosuppression in the neurorehabilitation pathway in patients with stroke.

Detailed Description

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The perfect balance between nervous and immune system could be severely impaired after brain injuries, such as strokes.

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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Stroke Lymphopenia Immunosuppression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of first episode of ischemic stroke or primary spontaneous intracerebral haemorrhage (both confirmed by proper neuroimaging)
* admission to the Neurorehabilitation ward within 30 days from the index event

Exclusion Criteria

* medical history of immunodeficiency or immunoproliferative disease
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Headache Science & Neurorehabilitation Center

Pavia, , Italy

Site Status

Countries

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Italy

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.

Reference Type RESULT
PMID: 16163382 (View on PubMed)

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.

Reference Type RESULT
PMID: 29600006 (View on PubMed)

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.

Reference Type RESULT
PMID: 22664787 (View on PubMed)

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.

Reference Type RESULT
PMID: 28004330 (View on PubMed)

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.

Reference Type RESULT
PMID: 21789273 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38594322 (View on PubMed)

Other Identifiers

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NeuroLympho

Identifier Type: -

Identifier Source: org_study_id

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