- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889169
Stroke-induced Immunodepression in Neurorehabilitation (NeuroLympho)
Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pavia, Italy, 27100
- Headache Science & Neurorehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stroke patients with immunosuppression
Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio >= 5 at hospital admission
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Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
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Stroke patients without immunosuppression
Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio < 5 at hospital admission
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Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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To evaluate if stroke-induced immunosuppression is a predictor of functional independence at the end of neurorehabilitation as measured by FIM score.
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After four to eight weeks from NRB admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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To evaluate if stroke-induced immunosuppression is a predictor of neurological function at the end of neurorehabilitation as measured by NIHSS score.
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After four to eight weeks from NRB admission
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Difference between group 1 and group 2 in Barthel Index after rehabilitation
Time Frame: After four to eight weeks from NRB admission
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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
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After four to eight weeks from NRB admission
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Difference between group 1 and group 2 in Tinetti score after rehabilitation
Time Frame: After four to eight weeks from NRB admission
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To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Tinetti score
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After four to eight weeks from NRB admission
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Difference between group 1 and group 2 in Hauser Ambulation Index score after rehabilitation
Time Frame: After four to eight weeks from NRB admission
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To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Hauser Ambulatory Index
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After four to eight weeks from NRB admission
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Difference between group 1 and group 2 in infectious complication during rehabilitation
Time Frame: After four to eight weeks from NRB admission
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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)
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After four to eight weeks from NRB admission
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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 Apr;26(2):160-166. doi: 10.1007/s12028-016-0367-2.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeuroLympho
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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