- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039399
Ischemic Conditioning Chronic Stroke Study
August 23, 2023 updated by: Matthew J. Durand, Medical College of Wisconsin
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
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
- Name: Matthew J Durand, Ph.D.
- Phone Number: 4149555619
- Email: mdurand@mcw.edu
Study Contact Backup
- Name: Jennifer Nguyen, BS
- Phone Number: 4147791317
- Email: jnguyen@mcw.edu
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
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
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Study participants must be between 18-85 years of age, able to give informed consent, >1 year post diagnosis of unilateral cortical or sub-cortical stroke, have residual lower limb paresis.
Exclusion Criteria:
- History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. wounds in the leg), chronic pain syndrome, history of head trauma, comorbid neurological disorder, any uncontrolled hypertension (>160/100 mmHg), peripheral vascular disease, a myocardial infarction in the previous year, inability to follow 2 step commands, or history of multiple strokes.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ischemic Conditioning
Study participants will receive one session of ischemic conditioning on their affected leg with cuff inflation to 225 mmHg.
|
Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times.
In our study, participants will receive one session of the intervention (45 minutes total).
|
Sham Comparator: Sham Ischemic Conditioning
Study participants will receive one session of sham ischemic conditioning on their affected leg with cuff inflation to 10 mmHg.
|
There will also be an IC Sham group which is identical to the IC intervention, except the cuff is only inflated to 10 mmHg, which is a high enough pressure to perceive cuff tightness but not high enough to have any physiological effects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plasma Norepinephrine Concentration
Time Frame: Through study completion, an average of 1 year
|
We will compare the absolute change in plasma norepinephrine from immediately after IC or IC Sham to immediately after the cold pressor test (i.e. the change in concentration from rest to immediately after the cold pressor test; comparison is deltaIC vs. deltaIC Sham).
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plasma Epinephrine Concentration
Time Frame: Through study completion, an average of 1 year
|
We will compare the absolute change in plasma epinephrine from immediately after IC or IC Sham to immediately after the cold pressor test (i.e. the change in concentration from rest to immediately after the cold pressor test; comparison is deltaIC vs. deltaIC Sham).
|
Through study completion, an average of 1 year
|
Change in Systolic Blood Pressure
Time Frame: Through study completion, an average of 1 year
|
We will compare the absolute change in systolic blood pressure from immediately after IC or IC Sham to immediately after the cold pressor test (i.e. the change in systolic blood pressure from rest to immediately after the cold pressor test; comparison is deltaIC vs. deltaIC Sham).
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2019
Primary Completion (Actual)
August 23, 2023
Study Completion (Actual)
August 23, 2023
Study Registration Dates
First Submitted
July 25, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 31, 2019
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00033275
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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