Ischemic Conditioning for Stroke Recovery

Recruiting at 1 trial location

Overseen By Matthew J Durand, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Deep vein thrombosis, Neurological disorder, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method called Ischemic Conditioning (IC) to help stroke survivors improve their walking ability. IC is a simple, non-invasive procedure that has shown promise in boosting motor and cardiovascular functions in healthy individuals. The trial will test the effects of IC combined with treadmill training against other variations, including a placebo version of IC. Ideal candidates for this trial are stroke survivors who have experienced a stroke on one side of the brain, have difficulty walking, and have some leg weakness. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new rehabilitation methods for stroke survivors.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have any uncontrolled medical conditions, you may be excluded from participating.

What prior data suggests that ischemic conditioning is safe for stroke recovery?

Studies have shown that ischemic conditioning (IC) is generally safe and well tolerated. Research indicates that IC, which involves temporarily stopping blood flow to aid recovery, does not harm heart health. It has been tested in both healthy individuals and those with certain artery conditions without major issues.

Treadmill training, a common rehabilitation exercise, is usually safe and helps improve walking speed and leg strength. When combined with IC, both treatments aim to enhance recovery after a stroke.

Overall, studies have demonstrated that both IC and treadmill training are safe, making them promising options for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ischemic conditioning and treadmill training approach for stroke recovery because it combines a novel technique with physical therapy to enhance rehabilitation. Unlike standard post-stroke treatments like medication and physical therapy alone, ischemic conditioning involves brief, controlled blood flow restriction, which may stimulate brain repair and improve recovery outcomes. This method could offer a new avenue to enhance brain plasticity and functional recovery, potentially speeding up progress and offering hope for better long-term results for stroke survivors.

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

Research has shown that ischemic conditioning, a treatment in this trial, can help stroke patients recover by improving movement and blood flow. Studies indicate that this technique aids brain recovery and reduces damage to brain tissue. Treadmill training, another treatment option in this trial, also benefits stroke survivors by increasing walking speed and leg strength. The trial will evaluate the effects of combining these methods, which may lead to even better results, such as faster walking and stronger muscles. This combination helps the body adapt and recover more effectively after a stroke. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-85 who are at least one year post-diagnosis of a unilateral, cortical stroke and still have weakness in their lower limbs. They must be able to consent to the study and walk slower than what's expected for their age and sex.

Inclusion Criteria

I had a stroke over a year ago and still have weakness in my leg.

I walk slower than others my age and gender.

be able to give informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ischemic conditioning and treadmill training for 4 weeks, 3 times per week, totaling 12 sessions

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in walking speed, leg strength, and other physiological measures

4 weeks

Long-term Follow-up

Participants are assessed for durability of ischemic conditioning effects and other long-term outcomes

1 month post intervention

What Are the Treatments Tested in This Trial?

Interventions

• Ischemic Conditioning
• Ischemic Conditioning Sham
• Treadmill Training

Trial Overview The study tests Ischemic Conditioning (IC), a non-invasive procedure thought to improve motor function, exercise performance, and cardiovascular health. Participants will undergo IC alongside treadmill training compared with those receiving a sham treatment.

How Is the Trial Designed?

Group I: Ischemic Conditioning + Treadmill Training Experimental Treatment 2 Interventions

Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.

Group II: Ischemic Conditioning Only Active Control 1 Intervention

Study participants with prior history of stroke will receive only ischemic conditioning.

Group III: Healthy Control - Ischemic Conditioning + Treadmill Training Active Control 2 Interventions

Healthy control participants will receive both ischemic conditioning and treadmill training.

Group IV: Ischemic Conditioning Sham + Treadmill Training Placebo Group 2 Interventions

Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.

Ischemic Conditioning is already approved in China for the following indications:

Approved in China as Remote Ischemic Conditioning for:

• Acute ischemic stroke

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Marquette University

Collaborator

Trials

68

Recruited

202,000+

Published Research Related to This Trial

Remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) is safe for treating acute ischemic stroke, showing no significant differences in hemorrhagic transformation or adverse events compared to a sham treatment in a study of 49 patients.

While RIC did not improve overall functional outcomes measured by the modified Rankin Scale or NIHSS scores, it significantly reduced levels of high-sensitivity C-reactive protein, suggesting potential anti-inflammatory benefits that merit further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke. He, YD., Guo, ZN., Qin, C., et al.[2021]

Remote ischemic conditioning (RIC) was well tolerated in a pilot study of 26 patients with acute ischemic stroke, with 49 out of 52 treatment cycles completed, suggesting it is a safe intervention.

Patients receiving RIC showed a significant improvement in neurological outcomes at day 90, with a lower NIHSS score compared to the sham group, indicating potential efficacy in enhancing recovery after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke. England, TJ., Hedstrom, A., O'Sullivan, S., et al.[2022]

In a study of 1,776 patients with acute moderate ischemic stroke, early initiation of Remote Ischemic Conditioning (RIC) within 24 hours of stroke onset was associated with an 8.1% higher likelihood of achieving excellent functional outcomes at 90 days compared to usual care.

No significant benefits were observed for patients who received RIC treatment later (24-48 hours after onset) compared to the control group, indicating that timing of RIC is crucial for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time from Onset to Remote Ischemic Conditioning and Clinical Outcome After Acute Moderate Ischemic Stroke. Cui, Y., Chen, YN., Nguyen, TN., et al.[2023]

Remote ischemic conditioning (RIC) may enhance rehabilitation after ischemic stroke by triggering the body's own protective mechanisms, although its specific effects on the neural repair process are still not fully understood.

This review suggests that RIC could be a promising therapeutic strategy for stroke rehabilitation, highlighting the need for further research to clarify its mechanisms and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of remote ischemic conditioning as a potential strategy for neural repair poststroke. Yu, W., Ren, C., Ji, X.[2023]

The SERIC-IVT trial is evaluating the effectiveness and safety of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in 558 patients with acute ischemic stroke, aiming to improve functional outcomes at 90 days.

The study will assess whether RIC can lead to a 13.14% increase in favorable outcomes, measured by the modified Rankin Scale, while also monitoring for safety issues such as mortality and adverse events within the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke: A multicenter, randomized, parallel-controlled clinical trial (SERIC-IVT) Study design and protocol. Abuduxukuer, R., Guo, ZN., Zhang, P., et al.[2023]

Remote ischemic conditioning (RIC) was found to be safe and feasible for 20 patients with acute ischemic stroke undergoing endovascular treatment, with no serious RIC-related adverse events reported during the study.

At the 3-month follow-up, 55% of patients achieved functional independence, suggesting potential benefits of RIC, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Zhao, W., Che, R., Li, S., et al.[2022]

The study assessed the safety and feasibility of a novel rehabilitation strategy called early remote ischemic conditioning followed by exercise (RICE) in 40 patients with acute ischemic stroke, finding no significant safety concerns during the treatment.

While RICE showed a trend towards better recovery (55% achieving excellent recovery compared to 40% in the sham group), the results were not statistically significant, indicating the need for larger trials to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning (RIC) with exercise (RICE) is safe and feasible for acute ischemic stroke (AIS) patients. Tong, Y., Lee, H., Kohls, W., et al.[2022]

Remote ischemic conditioning (RIC) has been shown to significantly reduce the recurrence of ischemic stroke and improve patient prognosis at 90 days, based on a meta-analysis of 6392 patients from 17 randomized controlled trials.

RIC is considered safe, as it does not increase the risk of serious adverse events like death or intracerebral hemorrhage, although it may cause some benign RIC-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. Kan, X., Yan, Z., Wang, F., et al.[2023]

Citations

1. 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 ...

2. 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.

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

Effect of Remote Ischemic Conditioning vs Usual Care on ... In 2012, an estimated 37% of patients had a good prognosis through intravenous thrombolysis, and a 2016 meta-analysis estimated that about 46% ...

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. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033609

Duration of Remote Ischemic Conditioning and Outcome in ... Remote ischemic conditioning has been found to be effective in improving functional outcomes in acute ischemic stroke.

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

Efficacy and safety of remote ischemic conditioning for acute ... RIC could reduce the stroke recurrence and improve patients' prognosis. Intervention on bilateral upper limbs, 5 cycles, and a length of 50 min in each ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.981498/full

Remote ischemic conditioning (RIC) with exercise (RICE) ... Clinical studies have confirmed that RIC is safe and feasible within 24 h after stroke, including in patients with intravenous thrombolysis or mechanical ...