Stroke-induced Immunodepression in Neurorehabilitation

NCT05889169 | Completed

• 1 other identifier: NeuroLympho
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Lymphopenia; Immunosuppression

Keywords

Ischemic stroke; Intracerebral hemorrage; Neurological rehabilitation; Neurorehabilitation; Cerebrovascular disorders; Immunodepression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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

• 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 infectious complication during rehabilitation

  After four to eight weeks from NRB admission

Study Arms (2)

Stroke patients with immunosuppression

Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio \>= 5 at hospital admission

Other: Neurorehabilitation

Stroke patients without immunosuppression

Patients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio \< 5 at hospital admission

Other: Neurorehabilitation

Interventions

Neurorehabilitation OTHER

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

Stroke patients with immunosuppression; Stroke patients without immunosuppression

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from a single centre cohort admitted for stroke rehabilitation at the Neurorehabilitation Unit of the IRCCS Mondino Foundation (Pavia, Italy).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Headache Science & Neurorehabilitation Center

Pavia, 27100, Italy

Location

Related Publications (6)

• 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.

  PMID: 16163382 RESULT

• 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.

  PMID: 29600006 RESULT

• 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.

  PMID: 22664787 RESULT

• 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.

  PMID: 28004330 RESULT

• 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.

  PMID: 21789273 RESULT

• Vaghi G, Morotti A, Piella EM, Avenali M, Martinelli D, Cristina S, Allena M, Grillo V, Corrado M, Bighiani F, Cammarota F, Antoniazzi A, Ferrari F, Mazzacane F, Cavallini A, Pichiecchio A, Rognone E, Martinis L, Correale L, Castiglia SF, Trabassi D, Serrao M, Tassorelli C, De Icco R. The role of stroke-induced immunosuppression as a predictor of functional outcome in the neurorehabilitation setting. Sci Rep. 2024 Apr 9;14(1):8320. doi: 10.1038/s41598-024-58562-1.

  PMID: 38594322 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Stroke; Lymphopenia; Ischemic Stroke; Cerebrovascular Disorders

Interventions

Neurological Rehabilitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: June 5, 2023
• Study Start: February 1, 2019
• Primary Completion: May 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

IT (1)