NCT04039399

Ischemic Conditioning Chronic Stroke Study

Completed NA Last updated 25 August 2023

What this trial tests

NA trial testing Ischemic Conditioning in Stroke in 17 participants. Completed in 23 August 2023.

Timeline

1 July 2019

Primary endpoint
23 August 2023

23 August 2023

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	17
Start date	1 July 2019
Primary completion	23 August 2023
Estimated completion	23 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Ischemic Conditioning
• Sham Ischemic Conditioning

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Medical College of Wisconsin

Who can join

Adults 18 to 85, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Remote ischaemic conditioning for stroke: unanswered questions and future directions.
   Baig S, Moyle B, Nair KPS, Redgrave J, et al · · 2021 · cited 15× · PMID 33903181 · DOI 10.1136/svn-2020-000722