Stroke-induced Immunodepression in Neurorehabilitation

Stroke Clinical Trial

— NeuroLympho  

Official title:

Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05889169
• Other study ID #: NeuroLympho
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2023
• Source: IRCCS National Neurological Institute "C. Mondino" Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression
• Lymphopenia
• Stroke

Intervention

Other:
• Neurorehabilitation
Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)

Locations

Country	Name	City	State
Italy	Headache Science & Neurorehabilitation Center	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between group 1 and group 2 in FIM score (Functional Independence Measure) after rehabilitation	To evaluate if stroke-induced immunosuppression is a predictor of functional independence at the end of neurorehabilitation as measured by FIM score.	After four to eight weeks from NRB admission
Secondary	Difference between group 1 and group 2 in NIHSS score (National Institutes of Health Stroke Scale) after rehabilitation	To evaluate if stroke-induced immunosuppression is a predictor of neurological function at the end of neurorehabilitation as measured by NIHSS score.	After four to eight weeks from NRB admission
Secondary	Difference between group 1 and group 2 in Barthel Index after rehabilitation	To evaluate if stroke-induced immunosuppression is a predictor of performances in activities of daily living at the end of neurorehabilitation as measured by Barthel Index	After four to eight weeks from NRB admission
Secondary	Difference between group 1 and group 2 in Tinetti score after rehabilitation	To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Tinetti score	After four to eight weeks from NRB admission
Secondary	Difference between group 1 and group 2 in Hauser Ambulation Index score after rehabilitation	To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Hauser Ambulatory Index	After four to eight weeks from NRB admission
Secondary	Difference between group 1 and group 2 in infectious complication during rehabilitation	To evaluate if stroke-induced immunosuppression is a predictor of infectious complications during neurorehabilitation, namely: pneumonia (diagnosed in subjects with typical symptoms of respiratory infection, confirmed by chest X-ray abnormalities), urinary tract infections (diagnosed with a positive urine culture without evidence of contamination), sepsis (defined as acute organ dysfunction with evidence of a clear source of infection and isolation of specific pathogens on blood cultures without evidence of contamination) and other infectious complications (as gastrointestinal and skin infections)	After four to eight weeks from NRB admission