Clinical Trial

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

Study acronym: ICUAW
Recruiting
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Summary
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
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-19
notable Primary completion pushed: 2026-08-31 -> 2027-08-31 2026-05-19
minor Completion pushed: 2026-08-31 -> 2027-08-31 2026-05-19
Trial Details
NCT Number NCT07362862
Lead Sponsor Health Discovery Labs
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB), Mayo Clinic, Ascension Health, University of Texas at Austin
Conditions Sepsis, Critical Illness, ICU-acquired Muscle Weakness, ICU-acquired Weakness, ICUAW, Sarcopenia, Secondary Sarcopenia
Enrollment 50 participants
Start Date 2026-05-05
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-10