Post-stroke Immunological Changes in Young Stroke Patients

December 2, 2019 updated by: University Medicine Greifswald

Role of Th1-lymphocytes in the Development of Vascular Cognitive Impairment in Young Stroke Patients

In the present study, the investigators aim to elucidate the role of T-cells on cognitive decline in younger stroke patients, using repeated cognitive testing, brain imaging, and immunological analyses in the first 6 month after stroke. The examiners will investigate (i) the extent and duration of stroke-induced changes in T cell function within the peripheral blood of patients; and (ii) post-stroke cognitive functions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Demands from society on stroke patients of younger age are in most cases higher than for elderly stroke patients, because of occupational obligations and often their role as a caregiver for a young family. For example, return to their former workplace may be impossible even if cognitive deficits, e.g., in the memory domain, are only "minor" according to standardized tests. Thus, cognitive function after stroke is of utmost importance for activities of daily life and quality of life in young stroke patients. In order to prevent or at least reduce post-stroke cognitive decline, the mechanisms underlying the decline need to be further elucidated, to eventually develop new preventive and therapeutic approaches.

T-cell activation is associated with destruction of brain tissue. In neurodegenerative diseases that primarily impair cognitive functions, e. g., Alzheimers Disease, T-cells were identified as important mediators of disease pathology. Activation of cells of the adaptive immune system, most importantly T-cells, has been also investigated in experimental stroke. Here, these cells significantly contribute to secondary brain tissue damage. Stroke is associated with massive changes of the central and peripheral immune response. The investigators and other groups demonstrated that despite an overall lymphopenia, T-cells are functionally intact and pro-inflammatorily polarized, for at least two weeks post-stroke. Depletion of T cells has been shown to reduce infarct volume and to improve outcome in mice post-experimental stroke.

Study Type

Observational

Enrollment (Anticipated)

77

Contacts and Locations

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

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Baseline visit: Patients will be recruited into the study within the first 72 hours after stroke onset. Only patients who are able to give their informed consent will be included in the study.

Follow-up investigations: Follow-up investigations are scheduled for the 4th week post-stroke and after six months.

Description

Inclusion criteria

  • Acute stroke that occurred within the last 72 hours as defined by acute neurological deficit in combination with an acute ischaemic infarct as documented by either a "Diffusion weighted imaging" (DWI)-positive lesion on MR imaging or a new lesion on a CT scan; only cortical/subcortical infarcts will be included
  • Age > 18; ≤ 55
  • Provision of written informed consent or through a surrogate as appropriate
  • Willingness to participate in follow-up
  • National Institute of Health Stroke Scale Score (NIHSS) ≥ 4
  • German as first language (neuropsychological tests and cut-offs developed for native speakers)

Exclusion criteria

  • Patients are excluded if they are not able to give informed consent due to severe cognitive deficits
  • Signs of infection on admission (C-reactive protein ≥ 50 mg/L)
  • Patients receiving immunosuppressive drugs or diagnosed with a malignancy or severe neurological diseases other than stroke (e.g., neurodegenerative movement disorders, motoneuron diseases)

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
Group A (young stroke)
Young stroke patients (≤ 55); Analysis of T-lymphocytes regarding: post-stroke t-cell priming (activation marker, polarization), cognitive tests; structural MRI
Other: Analysis of T-lymphocytes
Analysis of T-lymphocytes regarding the development of cognitive function after stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune alterations, as determined via T-cell subtypes and function in comparison to cognitive outcome after stroke
Time Frame: 3 years
The pro-inflammatorily primed T-cell response after stroke is associated with post-stroke cognitive decline, cognitive decline over time in young stroke patients
3 years

Collaborators and Investigators

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

Sponsor

University Medicine Greifswald

Investigators

  • Study Director: Agnes Flöel, Prof.Dr.med., University Medicine Greifswald

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • immuno_stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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