MyokinE100 System for ICU-Acquired Weakness
This study is testing a new medical device called the MyokinE100 System. This device uses electrical signals to stimulate your thigh muscles if you are in the Intensive Care Unit (ICU) and at risk of losing muscle strength. The main goals are to see if the MyokinE100 System is safe and easy to use, and if it can help reduce muscle weakening in critically ill patients. You may be able to join if you are 18 to 85 years old, have been admitted to the ER or ICU within the last 48 hours, have a certain illness severity score (APACHE II score ≥ 13), and meet criteria for sepsis or severe sepsis. The study will measure changes in your leg muscle strength from when you enter the ICU until you leave, and also track any unexpected problems with the device. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive electrical muscle stimulation using the MyokinE100 device. Muscle strength will be assessed daily in the ICU for up to 14 days or until ICU discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for unanticipated adverse device effects from enrollment through 3 months after the study begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Oussama Hassan, M.D. · PRINCIPAL_INVESTIGATOR · Health Discovery Labs
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.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.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.