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 muscle stimulation of the thigh muscles * Have their muscle strength checked during the study * Complete a survey three months after ICU discharge to check on their recovery
Admitted to ER or ICU within the previous 48 hours
APACHE II score ≥ 13
Meets the criteria for sepsis or severe sepsis
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
Parallel
Electrical Muscle Stimulation System
DeviceParticipants 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.
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
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.
A single Unanticipated Adverse Device Effect (UADE) in any participant during the study is considered significant.
Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
Upper and lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score scale grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Twelve muscle groups will be tested for a total possible best score of 60. A 1-point change in MRC sum score is considered clinically significant.
Change in hand-grip muscle strength measured by handheld dynamometry from ICU admission to hospital discharge.
Handgrip muscle strength will be assessed using a handheld dynamometer (HHD) as an indicator of global muscle function. Participants will be considered to have ICU-Acquired Weakness (ICUAW) if the average handgrip strength is below the threshold of 11Kg for men or 7 Kg for woman. Higher scores in Kg indicate greater global muscle function.
Change in mobility status assessed by ICU Mobility Scale (IMS) from ICU admission to ICU discharge.
Functional mobility will be assessed using the ICU Mobility Scale (IMS), which ranges from 0 (lying in bed, no active movement) to 10 (walking independently without a gait aid). Higher scores indicate greater mobility.
Change in functional exercise capacity assessed by Six-Minute Walk Test (6MWT) between ICU discharge to hospital discharge.
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) which measures the distance a participant can walk on a flat surface in six minutes. A greater distance walked indicates better functional status.
Change in Impedance (Z), Reactance (X), and Phase Angle (PA) of the quadriceps muscle during the hospital stay.
Quadriceps muscle electrical properties will be measured using Electrical Impedance Myography (EIM). Measurements will include Impedance (Z in ohms), Reactance (X in ohms), and Phase Angle (PA in degrees), which reflect muscle composition. Lower Phase Angle and Reactance values indicate reduced muscle composition. Higher Impedance values generally indicate reduced muscle health.
Change in C-Terminal Agrin Fragment (CAF) level in blood and urine from enrollment to day 14.
C-Terminal Agrin Fragment (CAF) levels will be measured in blood and urine samples collected from enrollment through Day 14. Higher CAF levels may indicate increased neuromuscular junction degradation, while lower levels suggest better preservation of muscle function.
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Health Discovery Labs
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Mayo Clinic
Collaborator
Ascension Health
Collaborator
University of Texas at Austin
Collaborator
