StrokePhase 2MITONCT06930638
MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes
A Phase 2 study testing Ischemic Conditioning and Antioxidant Supplement in people with Stroke, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve… 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 and Antioxidant Supplement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 31 Dec 2026
- Phase
- Phase 2
- 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
- 18 - 85 years of age
- Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
- Able to give informed consent and follow 2-step command.
- English Speaking
Who cannot join
- Unable to stand from chair without physical assistance from another person (able to use assistive device).
- History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
- Chronic lasting symptoms (> 6 months) of severe COVID-19 (i.e., hospitalization)
- History of head trauma or concussion within the past 6 months
- Comorbid neurological disorder
- Peripheral vascular disease
Show all 10Show fewer
- Myocardial infarction or arrhythmia in the previous year
- Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
- Pregnant or breastfeeding.
- Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Matthew J Durand, Ph.D., 414-955-5619, mdurand@mcw.edu
About this study
Official title: MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve vascular function and muscle activity in individuals post-stroke.
- Conditions
- Stroke
- Being tested
- Ischemic Conditioning, Antioxidant Supplement
- Keywords
- Ischemic Conditioning, Blood Flow, Microvascular Health, Flow-Mediated Dilation, Antioxidant, Reactive Oxygen Species, Supplement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic ConditioningDevice
The cuff will be placed around the proximal, non-affected thigh and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure.
Antioxidant SupplementDietary supplement
MitoQ is an over the counter supplement that increases delivery to the mitochondria. Similar to studies performed in middle age/older adults and individuals with peripheral arterial disease, we will administer 1 single oral dose of 80mg of MitoQ or a placebo pill. As MitoQ reaches peak concentrations at ~40 to 60 minutes after ingestion, we will wait 45 minutes (time matched to Ischemic conditioning).
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning - High | Experimental | During each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a high cuff inflation pressure on the leg, called ischemic conditioning - high (225 mmHg). Receives: Device: Ischemic Conditioning |
| Ischemic Conditioning - Low | Experimental | During each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a low cuff inflation pressure on the leg, called ischemic conditioning - low (25 mmHg). Receives: Device: Ischemic Conditioning |
| Antioxidant Supplement | Experimental | During each testing session, the investigators will be measuring how one treatment of an over-the-counter antioxidant supplement affects blood flow and muscle function. One day participants will orally ingest an over-the-counter antioxidant supplement called MitoQ. Receives: Dietary Supplement: Antioxidant Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow-Mediated Dilation
We will measure brachial artery vascular health in the non-paretic arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
Measured: Change from BL to Post Intervention (5 hours)
Microvascular Vasodilation
Laser Doppler Flowmetry (LDF) with Dermal Microdialysis (DM) will measure blood flow flux during microinfusions of study drugs (limited to an area on the skin approximately the size of a nickel) to examine endothelial dependent vasodilation (Acetylcholine, ACh) and nitric-oxide mediated vasodilation (ACH +/- LNAME, and endothelial nitric oxide synthase inhibitor).
Measured: Change from BL to Post Intervention (5 hours)
Secondary outcomes (2)
Muscle Tissue Oxygenation
We will also place a near-infrared spectroscopy (NIRS) pad on the thenar eminence of the non-paretic hand to non-invasively measure tissue oxygenation via infrared light following the pneumatic forearm cuff inflation/deflation.
Measured: Change from BL to Post Intervention (5 hours)
Blood Draw
We will collect blood before and after the intervention via an in-dwelling intravenous catheter. The blood draw analysis may include but will not be limited to examining complete blood counts, glucose levels, cholesterol, and plasma redox and bioenergetic analyses.
Measured: Change from BL to Post Intervention (5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start22 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- Investigators
- Matthew Durand, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930638
- Sponsor's protocol ID
- PRO00054821
- Acronym
- MITO
- Status last verified
- Sep 2025
- First submitted
- 9 Apr 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- 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
- MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)
- ClinicalTrials.gov ID
- NCT06930638
- Acronym / sponsor ID
- MITO / PRO00054821
- Conditions
- Stroke
- Keywords
- Ischemic Conditioning, Blood Flow, Microvascular Health, Flow-Mediated Dilation, Antioxidant, Reactive Oxygen Species, Supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2025 (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.
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve vascular function and muscle activity in individuals post-stroke.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning - High | Experimental | Device: Ischemic ConditioningDuring each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a high cuff inflation pressure on the leg, called ischemic conditioning - high (225 mmHg). |
| Ischemic Conditioning - Low | Experimental | Device: Ischemic ConditioningDuring each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a low cuff inflation pressure on the leg, called ischemic conditioning - low (25 mmHg). |
| Antioxidant Supplement | Experimental | Dietary Supplement: Antioxidant SupplementDuring each testing session, the investigators will be measuring how one treatment of an over-the-counter antioxidant supplement affects blood flow and muscle function. One day participants will orally ingest an over-the-counter antioxidant supplement called MitoQ. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 85 years of age
- Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
- Able to give informed consent and follow 2-step command.
- English Speaking
Key exclusion criteria (10 listed)
- Unable to stand from chair without physical assistance from another person (able to use assistive device).
- History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
- Chronic lasting symptoms (> 6 months) of severe COVID-19 (i.e., hospitalization)
- History of head trauma or concussion within the past 6 months
- 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 ConditioningThe cuff will be placed around the proximal, non-affected thigh and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure. | Device | Ischemic Conditioning - High, Ischemic Conditioning - Low |
| Antioxidant SupplementMitoQ is an over the counter supplement that increases delivery to the mitochondria. Similar to studies performed in middle age/older adults and individuals with peripheral arterial disease, we will administer 1 single oral dose of 80mg of MitoQ or a placebo pill. As MitoQ reaches peak concentrations at ~40 to 60 minutes after ingestion, we will wait 45 minutes (time matched to Ischemic conditioning). | Dietary supplement | Antioxidant Supplement |
Primary outcome
Brachial Artery Flow-Mediated Dilation
Time frame: Change from BL to Post Intervention (5 hours)
We will measure brachial artery vascular health in the non-paretic arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
Microvascular Vasodilation
Time frame: Change from BL to Post Intervention (5 hours)
Laser Doppler Flowmetry (LDF) with Dermal Microdialysis (DM) will measure blood flow flux during microinfusions of study drugs (limited to an area on the skin approximately the size of a nickel) to examine endothelial dependent vasodilation (Acetylcholine, ACh) and nitric-oxide mediated vasodilation (ACH +/- LNAME, and endothelial nitric oxide synthase inhibitor).
2 secondary outcomes
Muscle Tissue Oxygenation
Time frame: Change from BL to Post Intervention (5 hours)
Blood Draw
Time frame: Change from BL to Post Intervention (5 hours)
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.
Matthew Durand, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ischemic Conditioning and Antioxidant Supplement in people with Stroke, run by Medical College of Wisconsin at 1 site 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 10 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jennifer Nguyen (414-955-5713, jnguyen@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Flow-Mediated Dilation (time frame: Change from BL to Post Intervention (5 hours)). The study lists 2 primary outcomes in all. 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; AzTrials last refreshed its copy on 8 Nov 2026.