Ischemic Conditioning for Stroke Recovery

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

Disqualifiers: Deep vein thrombosis, Neurological disorder, others

Stay on Your Current Meds

Trial Summary

What is the purpose of this trial?

This trial will test if a simple procedure called Ischemic Conditioning can help stroke survivors walk better by improving nerve and blood vessel function. The study will involve stroke patients undergoing different combinations of this procedure and treadmill training over a period of time.

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 data supports the idea that Ischemic Conditioning for Stroke Recovery is an effective treatment?

The available research shows that Ischemic Conditioning, specifically Remote Ischemic Conditioning (RIC), is a promising treatment for stroke recovery. Studies indicate that RIC, when combined with other treatments like intravenous thrombolysis, may improve recovery outcomes for stroke patients. It is considered safe and feasible, even for those undergoing complex procedures like thrombectomy. Additionally, RIC can be used early in the recovery process, potentially offering similar protective benefits as exercise without the risks associated with early physical activity. This makes it a valuable option for patients who are not yet stable enough for traditional rehabilitation exercises. ^{1 2 3 4 5}

What safety data exists for ischemic conditioning in stroke recovery?

The safety of remote ischemic conditioning (RIC) for acute ischemic stroke (AIS) patients has been demonstrated in several studies. It is considered safe and feasible for patients undergoing endovascular treatment, combined with intravenous thrombolysis, and when used with exercise as a rehabilitation strategy. A comprehensive meta-analysis also supports the safety of RIC for AIS treatment. ^{1 2 3 6 7}

Is the treatment Ischemic Conditioning, Treadmill Training a promising treatment for stroke recovery?

Yes, Ischemic Conditioning, also known as Remote Ischemic Conditioning (RIC), is a promising treatment for stroke recovery. It has been shown to be safe and may improve recovery outcomes by protecting the brain and aiding in rehabilitation after a stroke. ^{1 2 3 5 8}

Research Team

Eligibility Criteria

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.

I am between 18 and 85 years old.

Trial Timeline

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

Treatment Details

Interventions

• Ischemic Conditioning (Procedure)
• Ischemic Conditioning Sham (Procedure)
• Treadmill Training (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Joseph E. Kerschner

Medical College of Wisconsin

Chief Medical Officer since 2011

MD, specific institution not identified

Dr. John R. Raymond, Sr.

Medical College of Wisconsin

Chief Executive Officer since 2010

MD from the Medical University of South Carolina

Marquette University

Collaborator

Trials

68

Recruited

202,000+

Dr. Kimo Ah Yun

Marquette University

Chief Executive Officer

BA from California State University, Sacramento

Dr. Raj Mitra

Marquette University

Chief Medical Officer since 2023

MD from University of Central Florida

Findings from Research

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]

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]

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) 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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute stroke patients treated with thrombectomy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning (RIC) with exercise (RICE) is safe and feasible for acute ischemic stroke (AIS) patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Time from Onset to Remote Ischemic Conditioning and Clinical Outcome After Acute Moderate Ischemic Stroke. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A review of remote ischemic conditioning as a potential strategy for neural repair poststroke. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke. [2022]