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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.

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.

How does the ischemic conditioning device treatment for stroke differ from other treatments?

The ischemic conditioning device for stroke is unique because it likely involves a non-invasive method to protect brain tissue by temporarily restricting blood flow, which is different from traditional stroke treatments that focus on restoring blood flow or rehabilitation. This approach is novel as it aims to condition the brain to better withstand reduced blood supply, potentially offering a preventative strategy rather than just a reactive one. ^{1 2 3 4 5}

Research Team

Enrique Leira, MD

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

SMART Arm with outcome-triggered electrical stimulation: a pilot randomized clinical trial. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical improvement with intensive robot-assisted arm training in chronic stroke is unchanged by supplementary tDCS. [2019]

3. Sweden pubmed.ncbi.nlm.nih.gov

Robot-assisted rehabilitation of the paretic upper limb: rationale of the ARAMIS project. [2016]

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

Home stroke rehabilitation for the upper limbs. [2020]

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

Evaluation of functional electrical stimulation-assisted leg-propelled wheelchair in hemiplegic patients. [2008]