Ischemic Conditioning Device for Stroke

(ICARUS Trial)

Overseen By Amir Shaban, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amir Shaban

Disqualifiers: Intracranial hemorrhage, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 30 minutes to 3 hours

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment for individuals experiencing a stroke caused by a blockage in a large blood vessel. The focus is on using the Doctormate device, similar to a blood pressure cuff, to perform remote limb ischemic conditioning (a process to improve blood flow) while patients are transported by helicopter to a hospital for further treatment. Ideal participants are those with sudden stroke symptoms such as difficulty speaking or understanding, vision problems, or difficulty paying attention. As an unphased trial, this study provides a unique opportunity to contribute to innovative stroke treatment research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the Doctormate device is safe for use in stroke patients?

Research has shown that the Doctormate device, used for remote limb ischemic conditioning (RLIC), is generally safe. In one study, researchers tested RLIC on patients who had a sudden stroke and found it to be well-tolerated with no serious side effects. Another study demonstrated that using RLIC with the Doctormate device did not cause significant problems in patients with mild Alzheimer's disease. These findings suggest that the treatment is safe, with patients handling it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for strokes, which often involves clot-busting drugs and invasive procedures, the Doctormate device offers a non-invasive approach. This device is unique because it uses ischemic conditioning, a method that involves brief, controlled periods of reduced blood flow, to potentially protect brain tissue and improve outcomes. Researchers are excited about this treatment because it can be used en route to the hospital, potentially starting the protective process earlier than traditional methods. This innovative approach could lead to better recovery rates and improved quality of life for stroke patients.

What evidence suggests that the Doctormate device is effective for stroke?

Research has shown that remote limb ischemic conditioning (RLIC) might improve recovery for stroke patients. One study found that 79.6% of patients who received RLIC recovered well within 90 days, compared to 75.5% of those who did not. In this trial, participants will use the Doctormate device, which gently squeezes the limbs for short periods, potentially protecting the brain during a stroke. Early studies have shown promise for this method, suggesting it could effectively reduce stroke damage. While more research is needed, these early results are encouraging. ^{2 4 6 7 8}

Who Is on the Research Team?

Enrique Leira, MD

Principal Investigator

University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who have had a stroke due to a blocked large vessel and show certain symptoms like speech difficulty or vision loss. They must be able to consent, not be in another study, not pregnant (women under 55 need a test), and without diabetes, limb injuries, or other specific vascular issues.

Inclusion Criteria

You have a National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20.

I was evaluated for and received rtPA treatment if I was eligible.

I am experiencing symptoms like difficulty speaking or understanding, ignoring one side of my body, vision problems, or difficulty controlling my gaze, which may suggest a stroke.

Exclusion Criteria

I have diabetes.

I have had issues with blood flow or injuries in my arms or legs, or surgeries that affect measuring blood pressure there.

I am not pregnant, confirmed by a test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive remote limb ischemic conditioning (RLIC) using the Doctormate device during air transport

30 minutes to 3 hours

1 visit (in-person during transport)

Initial Evaluation

Participants are evaluated for side effects upon arrival at the comprehensive stroke center

Upon arrival

Follow-up

Participants are monitored for adverse events at 24 hours post-admission and at 3 months

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Doctormate device

Trial Overview The trial tests the Doctormate device on stroke patients during helicopter transport to see if it can protect brain tissue by temporarily restricting blood flow in a limb. The goal is to improve outcomes for those heading for clot removal procedures.

How Is the Trial Designed?

Group I: Ischemic Conditioning Experimental Treatment 1 Intervention

Doctormate device used en route to the comprehensive stroke center

Who Is Running the Clinical Trial?

Amir Shaban

Lead Sponsor

Trials

1

Recruited

10+

Enrique Leira

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

The SMART Arm training, whether combined with outcome-triggered electrical stimulation (OT-stim) or not, significantly improved upper arm function in stroke survivors compared to usual therapy alone, based on a study involving 8 participants over 4 weeks.

There was no significant difference in improvement between the two training methods (with or without OT-stim), suggesting that SMART Arm training itself is effective for enhancing rehabilitation outcomes in patients with severe paresis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMART Arm with outcome-triggered electrical stimulation: a pilot randomized clinical trial. Hayward, KS., Barker, RN., Brauer, SG., et al.[2013]

Robot ARAMIS is designed to enhance rehabilitation for patients with upper limb paralysis after a stroke, offering a more efficient and cost-effective alternative to traditional therapy methods.

The system aims to improve robot-patient interaction, addressing some of the limitations found in conventional rehabilitation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted rehabilitation of the paretic upper limb: rationale of the ARAMIS project. Dolce, G., Lucca, LF., Pignolo, L.[2016]

The functional electrical stimulation-assisted leg-propelled wheelchair (FES-LW) allowed hemiplegic stroke patients to complete tasks 40.1% faster and with significantly better control compared to traditional manual wheelchairs, as shown in a study with 20 participants.

Using the FES-LW also resulted in a notable reduction in spasticity of the affected ankle, indicating its potential benefits for improving mobility and comfort in hemiplegic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of functional electrical stimulation-assisted leg-propelled wheelchair in hemiplegic patients. Lo, HC., Tsai, KH., Yeh, CY., et al.[2008]

Intensive robot-assisted arm training significantly improved motor function in chronic stroke patients, with an average increase of 7.36 points on the Upper Extremity Fugl-Meyer scale after 12 weeks of training.

Transcranial direct current stimulation (tDCS) did not provide additional benefits over sham treatment when combined with robotic training, indicating that while robotic training is effective, tDCS may not enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical improvement with intensive robot-assisted arm training in chronic stroke is unchanged by supplementary tDCS. Edwards, DJ., Cortes, M., Rykman-Peltz, A., et al.[2019]

The Stroke Rehabilitation Exerciser is designed to enhance rehabilitation for stroke patients by providing personalized motor exercise plans that can be executed at home, improving both efficiency and effectiveness of therapy.

It utilizes a wireless inertial sensor system to track patient movements and offers real-time feedback to both patients and therapists, helping to ensure exercises are performed correctly and intensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home stroke rehabilitation for the upper limbs. Willmann, RD., Lanfermann, G., Saini, P., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330956/

Induced neuroprotection by remote ischemic ... Doctormate device,. 5 × 5′. 200 mmHg. Both upper extremities ... outcomes in patients with acute ischemic stroke: the RESCUE BRAIN randomized clinical trial.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01570231

Feasibility, Safety and Efficacy of Remote Ischemic ... This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect ...

3. neurologylive.com neurologylive.com/view/remote-ischemic-conditioning-improves-likelihood-excellent-outcomes-post-stroke

Remote Ischemic Conditioning Improves Likelihood of ... On secondary outcomes, 79.6% of patients in the RIC group had mRS score of 0 to 2 within 90 days, compared with 75.5% in the control grouo, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4424736/

combined treatment with remote ischemic conditioning and ... The only two treatments effective for acute ischemic stroke are reperfusion therapies. Despite testing of hundreds of neuroprotective agents and treatments, ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/1074248417715003

Remote Ischemic Conditioning: The Commercial Market The device uses a straightforward approach: once activated, a controller unit inflates an air bladder limb tourniquet to 200 mm Hg, maintains ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01570231

Feasibility, Safety and Efficacy of Remote Ischemic ... This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1592829/full

Evaluating the safety and feasibility of remote ischemic ... This trial aims to determine the safety, feasibility, and potential effectiveness of RIC as a multi-target intervention for mild Alzheimer's dementia.

8. journals.lww.com journals.lww.com/brci/fulltext/9900/a_randomized_blinded_dose_response_human_biomarker.44.aspx

A randomized blinded dose–response human biomarker ... Remote ischemic conditioning (RIC) is emerging as a simple, inexpensive, and safe intervention for improving systemic vascular health in ...