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Completed

NCT Number: NCT05889169

Stroke-induced Immunodepression in Neurorehabilitation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurorehabilitation

Other

Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)

Primary outcomes

  1. 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

  1. Difference between group 1 and group 2 in NIHSS score (National Institutes of Health Stroke Scale) after rehabilitation

    Time frame: After four to eight weeks from NRB admission

    To evaluate if stroke-induced immunosuppression is a predictor of neurological function at the end of neurorehabilitation as measured by NIHSS score.

  2. Difference between group 1 and group 2 in Barthel Index after rehabilitation

    Time frame: After four to eight weeks from NRB admission

    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

  3. Difference between group 1 and group 2 in Tinetti score after rehabilitation

    Time frame: After four to eight weeks from NRB admission

    To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Tinetti score

  4. Difference between group 1 and group 2 in Hauser Ambulation Index score after rehabilitation

    Time frame: After four to eight weeks from NRB admission

    To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Hauser Ambulatory Index

  5. Difference between group 1 and group 2 in infectious complication during rehabilitation

    Time frame: After four to eight weeks from NRB admission

    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)

Sponsors and collaborators

Lead sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Other

Registry information

Official study title

Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting

Acronym: NeuroLympho

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2023
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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