RecruitingNot Applicable

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

United States50 participantsStarted 2026-05-05

Plain-language 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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Admitted to ER or ICU within the previous 48 hours * APACHE II score ≥ 13 * Meets the criteria for sepsis or severe sepsis * Baseline Clinical Frailty Scale (CFS) ≤ 4 Exclusion Criteria: * Anticipated transfer to an ICU not participating in this study * Expected length of ICU stay \< 48 hours * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1My loved one is in the medical ICU with sepsis and is at risk for ICU-acquired muscle weakness — is the MyokinE100 electrical muscle stimulation device something worth discussing as a possible option for their care?
2Since this trial is listed as Phase NA, which often means it's evaluating a device rather than a drug, what is currently known about the safety of using electrical muscle stimulation on critically ill patients, and what kinds of adverse effects are they specifically watching for in this study?
3The trial is measuring muscle strength using something called the MRC sum score — can you explain what that means in practical terms, and what kind of improvement in strength or recovery would be considered meaningful for my family member's situation?
4Because this study is still in an early stage of recruiting and is actively collecting safety data on the device, how would you weigh the potential benefits of participating against the uncertainties that still exist, compared to the standard care my family member would receive in the ICU without the device?
5What are the day-to-day logistics of using the MyokinE100 system on a patient who is critically ill — does it require them to be awake or cooperative, and would it interfere with other treatments they are already receiving?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.

Timeframe: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.

Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge.

Timeframe: From Day 1 (enrollment) through the end of the subject's study participation at 3-months.

Trial details

NCT IDNCT07362862

SponsorHealth Discovery Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Oussama Hassan, M.D.

512-203-9474 O.Hassan@healthdiscoverylabs.com

View on ClinicalTrials.gov More Sepsis trials