MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
Recruiting now · Not applicable
Conditions studied: Sepsis, Critical Illness, ICU-acquired Muscle Weakness, ICU-acquired Weakness, ICUAW, Sarcopenia, Secondary Sarcopenia
In brief
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
Key facts
- Study ID
- NCT07362862
- Run by
- Health Discovery Labs
- People needed
- 50
- Starts
- 2026-05-05
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Admitted to ER or ICU within the previous 48 hours
- APACHE II score ≥ 13
- Meets the criteria for sepsis or severe sepsis
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Dell Seton Medical Center at The University of Texas — Austin, Texas, United States (enrolling)
- Ascension Seton Medical Center Austin — Austin, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.