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NCT04039399 · ClinicalTrials.gov registry record · NA
Ischemic Conditioning Chronic Stroke Study
A NA study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT04039399 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 17 participants.
The verdict
NCT04039399, a NA study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
Stroke is the leading cause of disability in adults in the United States. Despite advances in hyperacute stroke care, advancements in stroke rehabilitation are lagging. We have previously shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic conditioning (IC), can improve paretic leg strength, reduce muscle fatigue, and increase walking speed in chronic stroke survivors (\>1 year post-stroke). The IC procedure makes the paretic leg transiently ischemic (5 minutes) using a cuff inflated to 225 mmHg, and repeats the occlusion 5 times with 5 minute periods of rest between cycles (45 total minutes). It is well accepted that the response to IC is complex and involves local, humoral and neural factors. The mechanism by which IC can confer motor benefit in stroke survivors is unknown. The aim of this study is to examine if IC can increase sympathetic nervous system (SNS) activity, which would promote an increased cardiovascular response to exercise and increased muscle strength. We hypothesize that plasma epinephrine and norepinephrine levels will increase more during a cold pressor test (a well-tolerated test to induce a sympathetic response) in chronic stroke survivors who undergo a single session of IC vs. IC-Sham. To accomplish the goals of this study, 15 chronic stroke survivors will each make two visits to the adult translational research unit at Medical College of Wisconsin (MCW) to have either IC or IC-Sham performed on their paretic leg in a counterbalanced order. Venous blood will be drawn before and after the IC or IC-Sham procedure and after a two-minute cold pressor test where the study participants submerge their hand into a bucket of ice water. This will cause an increased sympathetic response, which will be assessed by measuring blood pressure and the relative increase in the levels of circulating catecholamines (epinephrine and norepinephrine, assessed by high performance liquid chromatography).
Interventions
- PROCEDURE Ischemic Conditioning
- PROCEDURE Sham Ischemic Conditioning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-08-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04039399
The ClinicalTrials.gov registry entry for NCT04039399 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ischemic Conditioning is the first listed.
NCT04039399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04039399 about?
NCT04039399 is a clinical study titled "Ischemic Conditioning Chronic Stroke Study". Stroke is the leading cause of disability in adults in the United States. Despite advances in hyperacute stroke care, advancements in stroke rehabilitation are lagging. We have previously shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic conditioning (IC), can ...
What is the current status of trial NCT04039399?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2019-07-01. Estimated completion is 2023-08-23.
What interventions are being tested in trial NCT04039399?
The interventions under investigation include: Ischemic Conditioning (PROCEDURE), Sham Ischemic Conditioning (PROCEDURE).
Who is sponsoring clinical trial NCT04039399?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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