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StrokeNeuroLymphoNCT05889169

Stroke-induced Immunodepression in Neurorehabilitation

An observational study of Stroke and Lymphopenia, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Stroke, Lymphopenia, Immunosuppression
What is being tested?
Neurorehabilitation
How many people
90 participants
Where
1 siteItaly
Study dates
1 Feb 2019to 30 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Headache Science & Neurorehabilitation Center

    Pavia, 27100

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Neurorehabilitation
Keywords
Ischemic stroke, Intracerebral hemorrage, Neurological rehabilitation, Neurorehabilitation, Cerebrovascular disorders, Immunodepression
Medical subject headings
Stroke, Lymphopenia, Ischemic Stroke, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurorehabilitationOther

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

Study groups in NCT05889169
Study groupRoleWhat they receive
Stroke patients with immunosuppressionPatients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio >= 5 at hospital admission
Receives: Other: Neurorehabilitation
Stroke patients without immunosuppressionPatients with ischemic or hemorrhagic stroke with a neutrophil to lymphocyte ratio < 5 at hospital admission
Receives: Other: Neurorehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After four to eight weeks from NRB admission

Secondary outcomes (5)

  1. 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.

    Measured: After four to eight weeks from NRB admission

  2. 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

    Measured: After four to eight weeks from NRB admission

  3. 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

    Measured: After four to eight weeks from NRB admission

  4. 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

    Measured: After four to eight weeks from NRB admission

  5. 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)

    Measured: After four to eight weeks from NRB admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start1 Feb 2019
  3. Primary completion30 May 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889169
Sponsor's protocol ID
NeuroLympho
Acronym
NeuroLympho
Status last verified
Jun 2023
First submitted
19 Jan 2023
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Raw data will be uploaded in the online Zenodo platform and available to other Researches upon reasonable request.

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.

    PubMed 16163382

  • 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.

    PubMed 29600006

  • 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.

    PubMed 22664787

  • 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.

    PubMed 28004330

  • 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.

    PubMed 21789273

  • 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.

    PubMed 38594322

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Lymphopenia, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889169, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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