Ischemic Conditioning Device for Stroke

(ICARUS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Amir Shaban, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Amir Shaban

Disqualifiers: Intracranial hemorrhage, Diabetes, Pregnancy, others

No Placebo Group

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.

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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.

Trial 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)

Participant Groups

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.

Group I: Ischemic Conditioning Experimental Treatment 1 Intervention

Doctormate device used en route to the comprehensive stroke center

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

Who Is Running the Clinical Trial?

Amir Shaban Lead Sponsor

Enrique Leira Lead Sponsor

References

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

SMART Arm with outcome-triggered electrical stimulation: a pilot randomized clinical trial. [2013] The SMART (SensoriMotor Active Rehabilitation Training) Arm is a nonrobotic device designed to allow stroke survivors with severe paresis to practice reaching. It can be used with or without outcome-triggered electrical stimulation (OT-stim) to augment movement. The aim of this study was to evaluate the efficacy of SMART Arm training when used with or without OT-stim, in addition to usual care, as compared with usual care alone during inpatient rehabilitation.

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

Clinical improvement with intensive robot-assisted arm training in chronic stroke is unchanged by supplementary tDCS. [2019] Intensive robot-assisted arm training in the chronic phase of stroke recovery can lead to clinical improvement. Combinatorial therapeutic approaches are sought to further optimize stroke recovery. Transcranial direct current stimulation (tDCS) is one candidate to combine with robotic training, as transient increases in excitability and improvements in motor behavior have separately been reported.

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

Robot-assisted rehabilitation of the paretic upper limb: rationale of the ARAMIS project. [2016] Robot ARAMIS (Automatic Recovery Arm Motility Integrated System) is intended to provide the therapist with novel and time/cost-efficient approaches to the rehabilitation of the paretic upper limb after stroke. The system has been designed and implemented based on common experience in rehabilitation and will provide a robot-patient interaction compensating for some intrinsic limitations of traditional treatments. Rationale, technical characteristics and application are described in detail here.

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

Home stroke rehabilitation for the upper limbs. [2020] Philips Research is developing and clinically testing solutions to increase the efficiency and effectiveness of rehabilitation. The Stroke Rehabilitation Exerciser supports patients and therapists in the implementation and execution of a personalized neurological motor exercise plan at home. It enables an efficient therapy planning for the medical professional and increases the training intensity for the patient. The Stroke Rehabilitation Exerciser coaches the patient through a sequence of neurological motor exercises, which are prescribed by the physiotherapist and uploaded to a patient unit. A wireless inertial sensor system records the patient's movements. The data is automatically analyzed for deviations from a personal movement target and patient and therapist are provided with adequate feedback.

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

Evaluation of functional electrical stimulation-assisted leg-propelled wheelchair in hemiplegic patients. [2008] Manual wheelchairs are an important mobility device for hemiplegic stroke patients, but understandably difficult to operate. A novel mobility device termed the functional electrical stimulation-assisted leg-propelled wheelchair (FES-LW) was proposed and a field test conducted to evaluate its clinical performance by comparison against a manual wheelchair (MW).