NeuroLympho: Stroke-induced Immunodepression in Neurorehabilitation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Stroke patients with immunosuppression Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio >= 5 at hospital admission |
Other: Neurorehabilitation
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 |
Other: Neurorehabilitation
Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
|
Outcome Measures
Primary Outcome Measures
- Difference between group 1 and group 2 in FIM score (Functional Independence Measure) after rehabilitation [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 Outcome Measures
- 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]
To evaluate if stroke-induced immunosuppression is a predictor of neurological function at the end of neurorehabilitation as measured by NIHSS score.
- Difference between group 1 and group 2 in Barthel Index after rehabilitation [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
- Difference between group 1 and group 2 in Tinetti score after rehabilitation [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
- Difference between group 1 and group 2 in Hauser Ambulation Index score after rehabilitation [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
- Difference between group 1 and group 2 in infectious complication during rehabilitation [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)
Eligibility Criteria
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:
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medical history of immunodeficiency or immunoproliferative disease
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immunosuppressive or immunomodulating therapy in the year before the index event
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systemic steroids in the six months before the index event
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Glasgow Coma Scale < 8 at hospital admission
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other diagnosis of neurological diseases
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missing clinical/demographic data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Headache Science & Neurorehabilitation Center | Pavia | Italy | 27100 |
Sponsors and Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NeuroLympho