MitoQ + Ischemic Conditioning for Stroke

(MITO Trial)

Overseen By Alicen Whitaker-Hilbig, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Disqualifiers: Blood clots, Severe COVID-19, Neurological disorder, Peripheral vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day per treatment session

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores treatments to help stroke survivors improve blood flow and muscle function. Researchers are testing two methods: ischemic conditioning, which uses a cuff to restrict blood flow on the leg, and an antioxidant supplement called MitoQ. They aim to determine if these treatments can lower the risk of future strokes and enhance exercise ability. The trial seeks participants who experienced a stroke over six months ago and still have some muscle weakness. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in stroke recovery.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that remote ischemic conditioning (RIC) is a safe and simple treatment. It involves temporarily stopping and then restoring blood flow, which can help protect the brain after a stroke. Research indicates that patients tolerate it well, with no serious side effects reported in trials for stroke management.

Studies have also shown that MitoQ, an antioxidant supplement targeting mitochondria (the energy producers in cells), is safe for humans. Researchers have tested it at doses up to eight times the daily recommendation and for periods up to a year without serious adverse effects. MitoQ is well-tolerated, making it a promising option for improving vascular function after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer innovative approaches to enhancing blood flow and muscle function after a stroke. Unlike typical treatments that may rely on medication to manage stroke recovery, ischemic conditioning involves using controlled blood pressure on the leg to stimulate the body’s natural protective mechanisms, with both low and high pressure options being explored. MitoQ, on the other hand, is an antioxidant supplement that targets oxidative stress, a key player in stroke damage, offering a novel way to potentially protect brain cells. These methods, focusing on non-invasive techniques and cellular protection, provide promising alternatives that could complement or enhance current stroke recovery strategies.

What evidence suggests that this trial's treatments could be effective for stroke survivors?

In this trial, participants will receive either ischemic conditioning or MitoQ to explore their potential benefits for stroke recovery. Previous studies have shown that ischemic conditioning can aid recovery after a stroke by improving blood flow and reducing brain damage, leading to better outcomes for stroke patients. Research indicates it can support neurological recovery and decrease brain damage after a stroke. Meanwhile, MitoQ enhances brain and cognitive functions after an injury by reducing oxidative stress, which results from free radicals. Studies have found that MitoQ can improve blood vessel health, crucial for stroke recovery. This trial explores both treatments for their potential to help stroke survivors regain better blood vessel and muscle function. ^{1 4 6 7 8}

Who Is on the Research Team?

Matthew Durand, PhD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for stroke survivors who had a cortical or sub-cortical stroke at least 6 months ago and still have some muscle weakness on one side. Participants must speak English, be able to understand and consent to the study's procedures, and follow simple instructions.

Inclusion Criteria

I can understand and follow simple instructions.

I speak English.

I had a stroke over 6 months ago and still have weakness on one side.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ischemic conditioning or take an antioxidant supplement to assess vascular health outcomes

1 day per treatment session

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ischemic Conditioning
• MitoQ

Trial Overview The trial is testing whether ischemic conditioning (a technique that briefly restricts blood flow) or taking an antioxidant supplement called MitoQ can improve vascular health and muscle function in people who have had a stroke.

How Is the Trial Designed?

Group I: Ischemic Conditioning - Low Experimental Treatment 1 Intervention

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).

Group II: Ischemic Conditioning - High Experimental Treatment 1 Intervention

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).

Group III: Antioxidant Supplement Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6331204/

Remote ischemic conditioning for stroke: clinical data, ... This review focuses on recent advances in clinical studies of RIC in stroke management, its challenges, and the potential directions of future studies.

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.045040

Remote Ischemic Conditioning and Outcomes in Acute ... The primary outcome was excellent functional outcome at 90 days, defined as modified Rankin Scale score of 0 to 1. Compared with patients ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2795267

Effect of Remote Ischemic Conditioning vs Usual Care on ... Remote ischemic conditioning may improve outcomes of patients with cerebral small-vessel disease.  Stroke. 2017;48(11):3064-3072. doi ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405580825002717

Research progress on remote ischemic conditioning for ... Clinical studies have confirmed that remote ischemic conditioning improves neurological recovery, reduces infarct volume, and enhances prognosis. However, the ...

5. academic.oup.com academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaf570/8232488

the SERIC-EVT trial | European Heart Journal | Oxford Academic Remote ischaemic conditioning improves outcomes of ischaemic stroke treated by endovascular thrombectomy: the SERIC-EVT trial Open Access · PDF.

6. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.046615

Remote Ischemic Conditioning for Acute Ischemic Stroke Remote ischemic conditioning (RIC) is a safe and simple treatment that is being studied as a promising strategy to mitigate infarct growth and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04980651

Safety and Efficacy of Remote Ischemic Conditioning for ... Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10401132/

Efficacy and safety of remote ischemic conditioning for acute ... Remote ischemic conditioning (RIC) is a remote, transient, and noninvasive procedure providing temporary ischemia and reperfusion.