Ischemic Conditioning Chronic Stroke Study
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ClinicalTrials.gov Identifier: NCT04039399 |
Recruitment Status :
Recruiting
First Posted : July 31, 2019
Last Update Posted : December 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Stroke | Procedure: Ischemic Conditioning Procedure: Sham Ischemic Conditioning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | The study PI will be blinded to the intervention until after all plasma samples have been analyzed. |
Primary Purpose: | Treatment |
Official Title: | Ischemic Conditioning Chronic Stroke Study |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 30, 2025 |
Estimated Study Completion Date : | December 31, 2025 |

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.
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Procedure: Ischemic Conditioning
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.
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Procedure: Sham Ischemic Conditioning
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. |
- 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).
- 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).
- 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).

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039399
Contact: Matthew J Durand, Ph.D. | 4149555619 | mdurand@mcw.edu | |
Contact: Jennifer Nguyen, BS | 4147791317 | jnguyen@mcw.edu |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Matthew J Durand, Ph.D. 414-955-5619 mdurand@mcw.edu |
Documents provided by Matthew Durand, Medical College of Wisconsin:
Responsible Party: | Matthew Durand, Assistant Professor, Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT04039399 |
Other Study ID Numbers: |
PRO00033275 |
First Posted: | July 31, 2019 Key Record Dates |
Last Update Posted: | December 14, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |