Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
Study NCT ID:
NCT05889169
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2023-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stroke-induced Immunodepression in Neurorehabilitation
Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Organization:
Study Overview
Official Title:
Stroke-induced Immunodepression: Role in the Neurorehabilitation Setting
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeuroLympho
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.
Aim of the study was to evaluate the role of immunosuppression in the neurorehabilitation pathway in patients with stroke.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: