Skip to main content
Clinical Trials/NCT05889169
NCT05889169
Completed
Not Applicable

Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting

IRCCS National Neurological Institute "C. Mondino" Foundation1 site in 1 country90 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Enrollment
90
Locations
1
Primary Endpoint
Difference between group 1 and group 2 in FIM score (Functional Independence Measure) after rehabilitation
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
September 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference between group 1 and group 2 in FIM score (Functional Independence Measure) after rehabilitation

Time Frame: After four to eight weeks from NRB admission

To evaluate if stroke-induced immunosuppression is a predictor of functional independence at the end of neurorehabilitation as measured by FIM score.

Secondary Outcomes

  • Difference between group 1 and group 2 in infectious complication during rehabilitation(After four to eight weeks from NRB admission)
  • Difference between group 1 and group 2 in NIHSS score (National Institutes of Health Stroke Scale) after rehabilitation(After four to eight weeks from NRB admission)
  • Difference between group 1 and group 2 in Hauser Ambulation Index score after rehabilitation(After four to eight weeks from NRB admission)
  • Difference between group 1 and group 2 in Barthel Index after rehabilitation(After four to eight weeks from NRB admission)
  • Difference between group 1 and group 2 in Tinetti score after rehabilitation(After four to eight weeks from NRB admission)

Study Sites (1)

Loading locations...

Similar Trials