Microcirculation and Plasticity After Stroke (IMPreST)

August 23, 2020 updated by: University of Zurich

The Interplay of Microcirculation and Plasticity After Ischemic Stroke

Reperfusion is the main goal of early medical interventions after stroke, such as thrombolysis and thrombectomy. Recanalization works only if applied early - the earlier the better, but with a statistical cutoff of 4.5 hours where risk of hemorrhage outweighs the benefit. Recently, this cutoff has been put into perspective using standardized perfusion measurements by magnetic resonance imaging (MRI) or computed tomography (CT). Two trials have shown that revascularization is beneficial up to 24 hours after stroke onset if patient selection is based on perfusion imaging. This suggests interindividual differences in the temporal evolution of an infarction. One explanation for interindividual differences is the variability of the collateral blood supply to the brain, which in turn can maintain different perfusion pressures around the infarct core, also called the penumbra region. Insufficient recruitment of these collateral pathways is an independent negative predictor of poor outcome; the insufficiency may in part be explained by insufficient dilatation of arterioles ("low dilator reserve"). So far, interventions to improve collateral perfusion, e.g., induced hypertension, have not demonstrated effectiveness, likely because our understanding of collateral perfusion, demand-dependent dilatation of arteries (cerebrovascular reserve, CVR) and their effect on microcirculation is insufficient.

Functional recovery after a brain lesion is based on plasticity. Plasticity involves the creation of new synapses, fibers (axons and dendrites) and lasting modification to synaptic strength as well as the formation and migration of new neurons. In the cortex surrounding an infarct, plasticity is facilitated by ischemia via modification of gene expression, i.e. a certain time window after stroke, and is stimulated by activity and training. Tissue microcirculatory status and perfusion surrounding the stroke lesion may play a role in the formation of this plasticity. The investigators will analyze the contributions of pre-existing vascular networks, the impact of stroke-affected vessels, timing and degree of recanalization success, brain excitability, and short-term intra-cortical inhibition to better understand how these factors relate to functional recovery after stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

49

Contacts and Locations

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

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutively admitted to the hospital

Description

Inclusion Criteria:

  • ≤72h First-ever clinical ischemic stroke at hospital admission
  • Occlusion of M1-segment of the middle cerebral artery, and/ or intracranial internal carotid artery, and perfusion deficits with cortical involvement
  • 18 years or above
  • Living independent before stroke (mRS ≤3)
  • Written informed consent of the patient or the when the patient is not able to participate in the consenting procedure, the written authorization of an independent doctor who is not involved in the research project to safeguard the interests of the patient; in that case, post-hoc written informed consent of the patient is needed, or when the patient remains unable to participate in the informed consent procedure, written informed consent of a next of kind

Exclusion Criteria:

  • Major cardiac, psychiatric and/ or neurological diseases
  • Early seizures
  • Known or suspected non-compliance, drug and/ or alcohol abuse
  • Contra-indications for Magnetic Resonance Imaging and Transcranial Magnetic Stimulation, such as a history of seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker; neuroleptic medication; known allergic reaction to contrast material
  • Documented evidence that the patient does not want to participate in any scientific study or, in case of lack of documented evidence, no behavior and/or expression(s) that indicate(s) refusal of the patient to participate in research

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
Single-group study
Assessment of microcirculation, brain plasticity and clinical function
Other: Observation of microcirculation and plasticity of the brain
Assessment of microcirculation, brain plasticity and clinical function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain microcirculation
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Change in microcirculation of the brain as measured by magnetic resonance imaging (MRI)
<72 hours; 7, 45 and 90 days after stroke onset
Change in brain plasticity
Time Frame: 7, 45 and 90 days after stroke onset
Change in plasticity of the brain as measured by transcranial magnetic stimulation (TMS)
7, 45 and 90 days after stroke onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Neurological impairments (scale range 0-42, higher values represent a worse outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Fugl-Meyer Motor Assessment - Upper Extremity Subscale
Time Frame: 7, 45 and 90 days after stroke onset
Upper limb motor function (scale range 0-66, higher values represent a better outcome)
7, 45 and 90 days after stroke onset
Fugl-Meyer Motor Assessment - Lower Extremity Subscale
Time Frame: 7, 45 and 90 days after stroke onset
Lower limb motor function (scale range 0-34, higher values represent a better outcome)
7, 45 and 90 days after stroke onset
Finger extension 1
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Ability to extend the fingers (scale range 0-2, higher values represent a better outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Finger extension 2
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Ability to extend the fingers (scale range 0-10, higher values represent a better outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Finger extension 3
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Ability to extend the fingers (scale range 0-3, higher values represent a worse outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Trunk Control Test
Time Frame: 7 and 90 days after stroke onset
Trunk ability (scale range 0-100, higher values represent a better outcome)
7 and 90 days after stroke onset
Functional Ambulation Categories
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Walking ability (independence) (scale range 0-5, higher values represent a better outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Ten-Meter Walk Test
Time Frame: 7, 45 and 90 days after stroke onset
Gait speed and cadence (scale range is time in seconds, higher values represent a worse outcome)
7, 45 and 90 days after stroke onset
Modified Rankin Scale
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Global disability (scale range 0-5, higher values represent a worse outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Mobilization
Time Frame: <72 hours; 7 days
Amount of mobilization (scale range is time in minutes, higher values represent a better outcome)
<72 hours; 7 days
Concomitant movement therapy
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Intensity of therapy based on charts (scale range is time in minutes, higher values represent a better outcome)
<72 hours; 7, 45 and 90 days after stroke onset
Related Serious Events
Time Frame: <72 hours; 7, 45 and 90 days after stroke onset
Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalization; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect)
<72 hours; 7, 45 and 90 days after stroke onset

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Study Chair: Andreas R Luft, Prof. MD, University of Zurich, University Hospital Zurich

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)

October 7, 2019

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr. 2019-00750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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