MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Help ICU Patients Maintain Muscle Strength

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates a thigh-targeted electrical muscle stimulation device used in the ICU to see if it is safe and practical for patients at risk of muscle weakness due to critical illness or sepsis. Participants are randomized to receive standard ICU care with or without daily 60-minute sessions of electrical stimulation during their ICU stay, with muscle strength monitored over time. The trial emphasizes safety, feasibility, and potential impact on muscle weakness progression. It involves adults admitted to participating ICUs with APACHE II scores indicating severity and sepsis criteria, excluding those with conditions that could interfere with the device or care plan. Results will inform whether a closed-loop EMS approach can be integrated into critical-care rehabilitation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Admitted to ER or ICU within the previous 48 hours
* APACHE II score ≥ 13
* Meets the criteria for sepsis or severe sepsis

Exclusion Criteria:

* 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's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Dell Seton Medical Center at The University of Texas
  Austin, Texas, United States Recruiting
• Ascension Seton Medical Center Austin
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Oussama Hassan, M.D. — Health Discovery Labs
• Study coordinator: Oussama Hassan, M.D.
• Email: O.Hassan@healthdiscoverylabs.com
• Phone: 512-203-9474

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.