NCT07362862 · Health Discovery Labs
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
(ICUAW)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Electrical Muscle Stimulation System
Participants will receive electrical muscle stimulation at the level of the quadriceps using the MyokinE100 device, a closed-loop electrical muscle stimulation system. The closed-loop system monitors muscle response to electrical stimulation in real time using a biofeedback sensor and automatically adjusts stimulation intensity to achieve safe and effective muscle contractions.
Primary outcome measures
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Six muscle groups in lower limbs will be tested for a total best possible score of 30. A 1-point increase in MRC score per muscle group in the lower limbs is considered clinically significant.
Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge.
Time frame: From Day 1 (enrollment) through the end of the subject's study participation at 3-months.
A single Unanticipated Adverse Device Effect (UADE) in any participant during the study is considered significant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Pacemaker and implantable cardioverter-defibrillator
Where
- Rochester, Minnesota
- Austin, Texas
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), Mayo Clinic, Ascension Health, University of Texas at Austin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations