Blood Flow Regulation and Neuromuscular Function Post-Stroke
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ClinicalTrials.gov Identifier: NCT06027294 |
Recruitment Status :
Not yet recruiting
First Posted : September 7, 2023
Last Update Posted : September 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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Stroke | Procedure: Ischemic Conditioning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Blood Flow Regulation and Neuromuscular Function Post-Stroke |
Estimated Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | June 30, 2028 |
Estimated Study Completion Date : | June 30, 2028 |
Arm | Intervention/treatment |
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Experimental: 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 six sessions of ischemic conditioning over the course of two weeks.
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Procedure: Ischemic Conditioning
A cuff will be inflated to a pressure of 225 mmHg. |
Sham Comparator: Ischemic Conditioning Sham
There will also be an IC Sham group which is identical to the IC intervention, except the cuff will only be inflated to 10 mmHg, which is not a high enough pressure to occlude arterial blood flow.
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Procedure: Ischemic Conditioning
A cuff will be inflated to a pressure of 225 mmHg. |
- Functional Sympatholysis Magnitude [ Time Frame: Years 3-5 ]Functional sympatholysis will be measured as a change in leg vascular conductance (in ml/min/mmHg) from the exercise control condition to the exercise + cold pressor test condition.
- Time to muscle fatigue [ Time Frame: Years 3-5 ]The time (in seconds) it takes the knee extensor muscles to fatigue in response to a sustained, isometric muscle contraction will be measured, in seconds.
- Change in motor unit firing rates [ Time Frame: Years 3-5 ]The change in motor unit firing rates (in Hz) from the beginning to end of a fatiguing muscle contraction will be measured, in pulses per second, using surface EMG.
- Change in muscle metabolite accumulation will include muscle pH [ Time Frame: Years 3-5 ]Changes in muscle metabolite accumulation during fatiguing knee extensor exercise will be measured.
- Change in muscle metabolite accumulation [ Time Frame: Years 3-5 ]Changes in muscle metabolite accumulation during fatiguing knee extensor exercise will be measured. These metabolites and markers of muscle fatigue will include inorganic phosphate concentration (in mM), and diprotonated phosphate concentration (in mM).
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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:
- Be between 18-85 years of age
- Able to give informed consent
- ≥6 months post diagnosis of unilateral cortical or sub-cortical stroke
- English speaking
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
- Low back or hip pain that interferes with lower extremity motor testing
- History of head trauma
- Comorbid neurological disorder
- Peripheral vascular disease
- Myocardial infarction in the previous year
- Inability to follow 2 step commands
- Condition where fatiguing contractions or resisted leg contractions are contraindicated
- Resting SBP ≥160 mmHg or DBP ≥ 110 mmHg
- Pregnancy or breastfeeding.
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): NCT06027294
Contact: Matthew Durand, Ph.D. | 4149555619 | mdurand@mcw.edu | |
Contact: Jennifer Nguyen, BS | jnguyen@mcw.edu |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Marquette University | |
Milwaukee, Wisconsin, United States, 53233 |
Responsible Party: | Matthew J. Durand, Associate Professor, Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT06027294 |
Other Study ID Numbers: |
PRO00046423 |
First Posted: | September 7, 2023 Key Record Dates |
Last Update Posted: | September 7, 2023 |
Last Verified: | September 2023 |
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 |