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Microcirculation and Plasticity After Stroke

The Interplay of Microcirculation and Plasticity After Ischemic Stroke

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04035746
Acronym
IMPreST
Enrollment
49
Registered
2019-07-29
Start date
2019-10-07
Completion date
2022-01-31
Last updated
2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

Keywords

Microcirculation, Plasticity, Cohort studies

Brief summary

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.

Interventions

OTHERObservation of microcirculation and plasticity of the brain

Assessment of microcirculation, brain plasticity and clinical function

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in brain microcirculation<72 hours; 7, 45 and 90 days after stroke onsetChange in microcirculation of the brain as measured by magnetic resonance imaging (MRI)
Change in brain plasticity7, 45 and 90 days after stroke onsetChange in plasticity of the brain as measured by transcranial magnetic stimulation (TMS)

Secondary

MeasureTime frameDescription
Fugl-Meyer Motor Assessment - Lower Extremity Subscale7, 45 and 90 days after stroke onsetLower limb motor function (scale range 0-34, higher values represent a better outcome)
Finger extension 1<72 hours; 7, 45 and 90 days after stroke onsetAbility to extend the fingers (scale range 0-2, higher values represent a better outcome)
Finger extension 2<72 hours; 7, 45 and 90 days after stroke onsetAbility to extend the fingers (scale range 0-10, higher values represent a better outcome)
Finger extension 3<72 hours; 7, 45 and 90 days after stroke onsetAbility to extend the fingers (scale range 0-3, higher values represent a worse outcome)
Trunk Control Test7 and 90 days after stroke onsetTrunk ability (scale range 0-100, higher values represent a better outcome)
National Institutes of Health Stroke Scale<72 hours; 7, 45 and 90 days after stroke onsetNeurological impairments (scale range 0-42, higher values represent a worse outcome)
Ten-Meter Walk Test7, 45 and 90 days after stroke onsetGait speed and cadence (scale range is time in seconds, higher values represent a worse outcome)
Modified Rankin Scale<72 hours; 7, 45 and 90 days after stroke onsetGlobal disability (scale range 0-5, higher values represent a worse outcome)
Mobilization<72 hours; 7 daysAmount of mobilization (scale range is time in minutes, higher values represent a better outcome)
Concomitant movement therapy<72 hours; 7, 45 and 90 days after stroke onsetIntensity of therapy based on charts (scale range is time in minutes, higher values represent a better outcome)
Related Serious Events<72 hours; 7, 45 and 90 days after stroke onsetSerious 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)
Functional Ambulation Categories<72 hours; 7, 45 and 90 days after stroke onsetWalking ability (independence) (scale range 0-5, higher values represent a better outcome)
Fugl-Meyer Motor Assessment - Upper Extremity Subscale7, 45 and 90 days after stroke onsetUpper limb motor function (scale range 0-66, higher values represent a better outcome)

Countries

Switzerland

Contacts

Primary ContactAndreas R Luft, Prof. MD
andreas.luft@uzh.ch+41 (0)44 255 54 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026