StrokeNCT06027294
Blood Flow Regulation and Neuromuscular Function Post-Stroke
A study testing Ischemic Conditioning in people with Stroke, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
The muscles of stroke survivors can fatigue faster compared to muscles in people who have not had a stroke, which can limit how long a person with stroke can perform tasks such as walking. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ischemic Conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Nguyen, BS contact
United States2 sites, 2 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Matthew J Durand, Ph.D., 414-955-5619, mdurand@mcw.edu
- Recruiting
Marquette University
Milwaukee, Wisconsin, 53233
Allison S. Hyngstrom, PT, PhD, 414-288-4566, allison.hyngstrom@marquette.edu
About this study
The muscles of stroke survivors can fatigue faster compared to muscles in people who have not had a stroke, which can limit how long a person with stroke can perform tasks such as walking. This study will examine how blood flow is regulated to the exercising leg muscle post-stroke, because if the muscle does not receive enough blood flow it will become fatigued. Finally, the investigators will use a safe and simple non-invasive intervention called ischemic conditioning, which has known effects to improve blood flow to exercising muscle and determine the effects on muscle fatigue.
Read the detailed description
This study will examine peripheral blood flow regulation in the exercising muscle of stroke survivors and determine relationships between hyperemic blood flow and the functional sympatholysis magnitude with measures of muscle fatigue. In Aim 3 the investigators will conduct a parallel group, randomized, controlled, double-blinded clinical trial that will examine the effects of ischemic conditioning on the functional sympatholysis response, muscle fatigue resistance and metrics of muscle fatigability. In total the investigators intend to recruit 60 chronic stroke survivors and 20 age- and sex-matched controls. Stroke survivors will be recruited from HIPAA compliant databases and from the outpatient stroke clinics within the Department of Physical Medicine and Rehabilitation at the Medical College of Wisconsin.
In Aim 1 the investigators propose to recruit 20 chronic stroke survivors and 20 age- and sex-matched control participants. Stroke survivors will be asked to make six visits to the laboratories at Marquette University and the Medical College of Wisconsin, and the investigators will perform measurements on both the paretic and non-paretic legs (three test sessions on each leg). Control participants will be asked to make three visits to the laboratories, and the investigators will test the dominant leg. In one visit, the functional sympatholysis response will be assessed by having participants perform single leg, isometric, repeated knee extensor contractions at 40% of the maximum voluntary isometric contraction (MVIC) torque on a Biodex dynamometer for a total of seven minutes. During the final two minutes of the exercise protocol the foot of the non-exercising leg will be placed in an ice bath to increase sympathetic nervous system activity. Blood pressure and blood flow through the superficial femoral artery will be continuously monitored and the magnitude of the functional sympatholysis response will be calculated as a change in leg vascular conductance from the exercise control condition to the exercise + ice condition. In a separate visit the test leg will perform a single, isometric, sustained, fatiguing muscle contraction with the knee extensor muscles equal to 30% of the MVIC. Motor unit firing rates will be continuously measured during the muscle contraction using surface electromyograph (EMG). Finally, in the third test session muscle metabolite accumulation will be measured during isometric knee extensor contractions using 31P magnetic resonance spectroscopy (MRS). After all test sessions are complete, the investigators will compare the functional sympatholysis magnitude between the three test groups (paretic leg, non-paretic leg, control leg) and will examine if there is a relationship between the functional sympatholysis magnitude and 1) the time to muscle fatigue, 2) the change in motor unit firing rates during a fatiguing muscle contraction, and 3) metabolite buildup in the muscle (peak H2PO4- concentration) during fatiguing contractions.
In Aim 2 the investigators will also recruit 20 chronic stroke survivors and 20 age- and sex-matched control participants. Those participants who completed Aim 1 will also be asked to complete Aim 2. Stroke survivors will be asked to make two visits to the Translational Research Unit at the Medical College of Wisconsin, while control participants will be asked to make one visit. During these visits the investigators will separately examine the vasoactive effects of norepinephrine and acetylcholine +/- the endothelial nitric oxide inhibitor L-NAME in the cutaneous microvasculature of the legs using laser Doppler flowmetry with dermal microdialysis. The investigators will calculate the change in cutaneous vascular conductance for each compound that is infused, and the investigators will compare the maximum change between the three groups (paretic leg, non-paretic leg and control leg). The investigators will also examine the relationship between the maximum change in cutaneous vascular conductance during acetylcholine infusion (i.e., the maximum vasodilation) and 1) the functional sympatholysis magnitude, 2) the time to muscle fatigue, 3) the change in motor unit firing rates during a fatiguing muscle contraction, and 4) metabolite buildup in the muscle (peak H2PO4- concentration) during fatiguing contractions.
In Aim 3 the investigators will conduct a parallel group, randomized, controlled, double-blinded clinical trial that will enroll study participants into either an ischemic conditioning (IC) intervention group or an IC-Sham control group. The investigators will enroll a total of 40 chronic stroke survivors (20 individuals split between two groups) and the investigators will only perform testing on the paretic leg. Study participants will be asked to make a total of ten visits to the laboratories at Marquette University and the Medical College of Wisconsin over the course of six weeks. Participants in both groups will receive a handheld sphygmomanometer and blood pressure cuff and the intervention will be performed at home every other day (six total sessions). For the IC group, the cuff be placed around the proximal, paretic thigh and inflated to 225 mmHg for 5 minutes with the participants in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation/recovery will be performed. IC Sham will consist of the same physical set-up as above, but the cuff will only be inflated to 10 mmHg. The same compliment of tests described in Aim 1 will be performed at baseline, immediately after the two-week intervention, and two-weeks after the end of the intervention period. The investigators will determine whether the functional sympatholysis response improved in the IC group vs. the IC-Sham group and examine relationships between the change in functional sympatholysis and 1) the time to muscle fatigue, 2) the change in motor unit firing rates during a fatiguing muscle contraction, and 3) metabolite buildup in the muscle (specifically the peak H2PO4- concentration) during fatiguing contractions.
- Conditions
- Stroke
- Being tested
- Ischemic Conditioning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic ConditioningProcedure or surgery
A cuff will be inflated to a pressure of 225 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning | Experimental | 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. Receives: Procedure: Ischemic Conditioning |
| Ischemic Conditioning Sham | Sham comparator | 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. Receives: Procedure: Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Sympatholysis Magnitude
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.
Measured: Years 3-5
Secondary outcomes (4)
Time to muscle fatigue
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.
Measured: Years 3-5
Change in motor unit firing rates
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.
Measured: Years 3-5
Change in muscle metabolite accumulation will include muscle pH
Changes in muscle metabolite accumulation during fatiguing knee extensor exercise will be measured.
Measured: Years 3-5
Change in muscle metabolite accumulation
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).
Measured: Years 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start11 Jan 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Durand, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027294
- Sponsor's protocol ID
- PRO00046423
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Regulation and Neuromuscular Function Post-Stroke
- ClinicalTrials.gov ID
- NCT06027294
- Acronym / sponsor ID
- PRO00046423
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The muscles of stroke survivors can fatigue faster compared to muscles in people who have not had a stroke, which can limit how long a person with stroke can perform tasks such as walking. This study will examine how blood flow is regulated to the exercising leg muscle post-stroke, because if the muscle does not receive enough blood flow it will become fatigued. Finally, the investigators will use a safe and simple non-invasive intervention called ischemic conditioning, which has known effects to improve blood flow to exercising muscle and determine the effects on muscle fatigue.
Detailed description
This study will examine peripheral blood flow regulation in the exercising muscle of stroke survivors and determine relationships between hyperemic blood flow and the functional sympatholysis magnitude with measures of muscle fatigue. In Aim 3 the investigators will conduct a parallel group, randomized, controlled, double-blinded clinical trial that will examine the effects of ischemic conditioning on the functional sympatholysis response, muscle fatigue resistance and metrics of muscle fatigability. In total the investigators intend to recruit 60 chronic stroke survivors and 20 age- and sex-matched controls. Stroke survivors will be recruited from HIPAA compliant databases and from the outpatient stroke clinics within the Department of Physical Medicine and Rehabilitation at the Medical College of Wisconsin.
In Aim 1 the investigators propose to recruit 20 chronic stroke survivors and 20 age- and sex-matched control participants. Stroke survivors will be asked to make six visits to the laboratories at Marquette University and the Medical College of Wisconsin, and the investigators will perform measurements on both the paretic and non-paretic legs (three test sessions on each leg). Control participants will be asked to make three visits to the laboratories, and the investigators will test the dominant leg. In one visit, the functional sympatholysis response will be assessed by having participants perform single leg, isometric, repeated knee extensor contractions at 40% of the maximum voluntary isometric contraction (MVIC) torque on a Biodex dynamometer for a total of seven minutes. During the final two minutes of the exercise protocol the foot of the non-exercising leg will be placed in an ice bath to increase sympathetic nervous system activity. Blood pressure and blood flow through the superficial femoral artery will be continuously monitored and the magnitude of the functional sympatholysis response will be calculated as a change in leg vascular conductance from the exercise control condition to the exercise + ice condition. In a separate visit the test leg will perform a single, isometric, sustained, fatiguing muscle contraction with the knee extensor muscles equal to 30% of the MVIC. Motor unit firing rates will be continuously measured during the muscle contraction using surface electromyograph (EMG). Finally, in the third test session muscle metabolite accumulation will be measured during isometric knee extensor contractions using 31P magnetic resonance spectroscopy (MRS). After all test sessions are complete, the investigators will compare the functional sympatholysis magnitude between the three test groups (paretic leg, non-paretic leg, control leg) and will examine if there is a relationship between the functional sympatholysis magnitude and 1) the time to muscle fatigue, 2) the change in motor unit firing rates during a fatiguing muscle contraction, and 3) metabolite buildup in the muscle (peak H2PO4- concentration) during fatiguing contractions.
In Aim 2 the investigators will also recruit 20 chronic stroke survivors and 20 age- and sex-matched control participants. Those participants who completed Aim 1 will also be asked to complete Aim 2. Stroke survivors will be asked to make two visits to the Translational Research Unit at the Medical College of Wisconsin, while control participants will be asked to make one visit. During these visits the investigators will separately examine the vasoactive effects of norepinephrine and acetylcholine +/- the endothelial nitric oxide inhibitor L-NAME in the cutaneous microvasculature of the legs using laser Doppler flowmetry with dermal microdialysis. The investigators will calculate the change in cutaneous vascular conductance for each compound that is infused, and the investigators will compare the maximum change between the three groups (paretic leg, non-paretic leg and control leg). The investigators will also examine the relationship between the maximum change in cutaneous vascular conductance during acetylcholine infusion (i.e., the maximum vasodilation) and 1) the functional sympatholysis magnitude, 2) the time to muscle fatigue, 3) the change in motor unit firing rates during a fatiguing muscle contraction, and 4) metabolite buildup in the muscle (peak H2PO4- concentration) during fatiguing contractions.
In Aim 3 the investigators will conduct a parallel group, randomized, controlled, double-blinded clinical trial that will enroll study participants into either an ischemic conditioning (IC) intervention group or an IC-Sham control group. The investigators will enroll a total of 40 chronic stroke survivors (20 individuals split between two groups) and the investigators will only perform testing on the paretic leg. Study participants will be asked to make a total of ten visits to the laboratories at Marquette University and the Medical College of Wisconsin over the course of six weeks. Participants in both groups will receive a handheld sphygmomanometer and blood pressure cuff and the intervention will be performed at home every other day (six total sessions). For the IC group, the cuff be placed around the proximal, paretic thigh and inflated to 225 mmHg for 5 minutes with the participants in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation/recovery will be performed. IC Sham will consist of the same physical set-up as above, but the cuff will only be inflated to 10 mmHg. The same compliment of tests described in Aim 1 will be performed at baseline, immediately after the two-week intervention, and two-weeks after the end of the intervention period. The investigators will determine whether the functional sympatholysis response improved in the IC group vs. the IC-Sham group and examine relationships between the change in functional sympatholysis and 1) the time to muscle fatigue, 2) the change in motor unit firing rates during a fatiguing muscle contraction, and 3) metabolite buildup in the muscle (specifically the peak H2PO4- concentration) during fatiguing contractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning | Experimental | Procedure: Ischemic ConditioningIschemic 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. |
| Ischemic Conditioning Sham | Sham comparator | Procedure: Ischemic ConditioningThere 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic ConditioningA cuff will be inflated to a pressure of 225 mmHg. | Procedure or surgery | Ischemic Conditioning, Ischemic Conditioning Sham |
Primary outcome
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.
4 secondary outcomes
Time to muscle fatigue
Time frame: Years 3-5
Change in motor unit firing rates
Time frame: Years 3-5
Change in muscle metabolite accumulation will include muscle pH
Time frame: Years 3-5
Change in muscle metabolite accumulation
Time frame: Years 3-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Nguyen, BS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Conditioning in people with Stroke, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Durand, Ph.D. (4149555619, mdurand@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Sympatholysis Magnitude (time frame: Years 3-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.