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MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients

RecruitingNAAges 18 Years - 85 YearsAllHealth Discovery Labs
NCT07362862 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening. The main questions this study aims to answer are: * Do participants develop medical problems when receiving electrical muscle stimulation in the ICU? * Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients? Researchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use. Participants will: * Receive either standard of care or standard of care plus electrical

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📋 Eligibility rules (as published)
Inclusion Criteria: * Admitted to ER or ICU within the previous 48 hours * APACHE II score ≥ 13 * Meets the criteria for sepsis or severe sepsis Exclusion Criteria: * Anticipated transfer to an ICU not participating in this study * Myopathies (e.g. congenital) * Acquired myopathies with CK levels 5-times above the upper limit of normal * Unable to transfer from bed to chair at baseline * Moribund * Comfort care * New onset deep vein thrombosis within the previous 6-months * Malignancy in lower limb * Technical obstacles - fracture, burns, amputation * Open wound or skin abrasion at the garment application site * Pregnancy * Pacemaker and implantable cardioverter-defibrillator
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What it tests

  • Electrical Muscle Stimulation System
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Where

3 sites
Mayo Clinic
Rochester, United States
Dell Seton Medical Center at The University of Texas
Austin, United States
Ascension Seton Medical Center Austin
Austin, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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