What side effects are associated with this type of intervention?

Common treatments for stroke, such as physical therapy, exercise, and ischemic conditioning, generally have minimal side effects. Physical therapy and exercise can sometimes lead to muscle soreness, fatigue, or transient increases in pain. Ischemic conditioning, which aims to improve motor function and vascular health, may cause transient skin petechiae in the treated area. Pharmacological treatments, such as anticoagulants and antiplatelet agents, can have more significant side effects, including bleeding risks. Overall, non-invasive treatments like exercise and ischemic conditioning are well-tolerated with few adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for stroke primarily include thrombolytics like alteplase (tPA), which dissolves blood clots to restore blood flow. Other treatments focus on antiplatelet agents (e.g., aspirin) and anticoagulants (e.g., warfarin) to prevent clot formation. While these treatments do not directly align with the mechanisms of ischemic conditioning, they aim to improve blood flow and reduce further ischemic damage. There are no specific FDA-approved treatments that enhance motoneuron recruitment or neural adaptations similar to ischemic conditioning.

What other types of research exist?

Promising novel alternatives to Ischemic Conditioning for stroke patients include: 1) Neuromodulation techniques such as noninvasive nerve stimulation, which has shown efficacy in improving motor function. 2) Adaptive devices like wearable robots and neuroprostheses that assist in motor function and tremor reduction. 3) High-intensity exercise programs, which have been shown to improve vascular function and neural adaptations. These alternatives offer potential benefits in enhancing motoneuron recruitment, neural adaptations, and vascular function.

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Ischemic Conditioning for Stroke Recovery

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

be ≥ 1 year post diagnosis of a unilateral, cortical stroke and have residual lower extremity paresis

walk slower than normative values based on age and sex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 4 weeks.

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, IC is generally considered low-risk. Potential side effects may include discomfort during the procedure or temporary changes in skin sensation where the conditioning is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I walk slower than others my age and gender.

Select...

I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 4 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 4 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 4 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self Selected Walking Speed

Secondary study objectives

Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery

Knee Extensor Fatigability

Knee Extensor Leg Strength

+1 more

Other study objectives

Ankle

Bipolar Surface Electromyography (EMG) Measurements

Ground Reaction Force

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Ischemic Conditioning + Treadmill TrainingExperimental Treatment2 Interventions

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

Group II: Ischemic Conditioning OnlyActive Control1 Intervention

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

Group III: Healthy Control - Ischemic Conditioning + Treadmill TrainingActive Control2 Interventions

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

Group IV: Ischemic Conditioning Sham + Treadmill TrainingPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treadmill Training

2009

Completed Phase 1

~140

Ischemic Conditioning

2019

N/A

~90

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ischemic conditioning (IC) involves repeated, transient occlusion and reperfusion of blood vessels, which enhances motoneuron recruitment, neural adaptations, vascular endothelial function, and peripheral blood flow. These mechanisms are crucial for stroke patients as they promote recovery of motor function, improve exercise capacity, and enhance overall cardiovascular health. Additionally, IC may lead to positive neural adaptations that support better functional outcomes post-stroke. By improving blood flow and reducing brain damage, IC can significantly aid in the rehabilitation process for stroke patients.

Combination of early and delayed ischemic postconditioning enhances brain-derived neurotrophic factor production by upregulating the ERK-CREB pathway in rats with focal ischemia.Long-term functional recovery and compensation after cerebral ischemia in rats.