Stroke-induced Immunodepression in Neurorehabilitation (NeuroLympho)

June 1, 2023 updated by: IRCCS National Neurological Institute "C. Mondino" Foundation

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

Completed

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

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Headache Science & Neurorehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)

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
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 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
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
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
After four to eight weeks from NRB admission
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
After four to eight weeks from NRB admission
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
After four to eight weeks from NRB admission
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)
After four to eight weeks from NRB admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

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)?

UNDECIDED

IPD Plan Description

Raw data will be uploaded in the online Zenodo platform and available to other Researches upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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