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临床试验/NCT05889169
NCT05889169已完成不适用

Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting

IRCCS National Neurological Institute "C. Mondino" Foundation1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Difference between group 1 and group 2 in FIM score (Functional Independence Measure) after rehabilitation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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