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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHealth Discovery Labs

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Electrical Muscle Stimulation System

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Health Discovery Labs

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Mayo Clinic

Collaborator

Ascension Health

Collaborator

University of Texas at Austin

Collaborator