Stroke Clinical Trial
— NeuroLymphoOfficial title:
Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting
Verified date | June 2023 |
Source | IRCCS National Neurological Institute "C. Mondino" Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 30, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Headache Science & Neurorehabilitation Center | Pavia |
Lead Sponsor | Collaborator |
---|---|
IRCCS National Neurological Institute "C. Mondino" Foundation |
Italy,
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between group 1 and group 2 in FIM score (Functional Independence Measure) after rehabilitation | To evaluate if stroke-induced immunosuppression is a predictor of functional independence at the end of neurorehabilitation as measured by FIM score. | After four to eight weeks from NRB admission | |
Secondary | Difference between group 1 and group 2 in NIHSS score (National Institutes of Health Stroke Scale) after rehabilitation | To evaluate if stroke-induced immunosuppression is a predictor of neurological function at the end of neurorehabilitation as measured by NIHSS score. | After four to eight weeks from NRB admission | |
Secondary | Difference between group 1 and group 2 in Barthel Index after rehabilitation | 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 | After four to eight weeks from NRB admission | |
Secondary | Difference between group 1 and group 2 in Tinetti score after rehabilitation | To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Tinetti score | After four to eight weeks from NRB admission | |
Secondary | Difference between group 1 and group 2 in Hauser Ambulation Index score after rehabilitation | To evaluate if stroke-induced immunosuppression is a predictor of motor performances at the end of neurorehabilitation as measured by Hauser Ambulatory Index | After four to eight weeks from NRB admission | |
Secondary | Difference between group 1 and group 2 in infectious complication during rehabilitation | 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) | After four to eight weeks from NRB admission |
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