Electrical Muscle Stimulation for Acquired Weakness
(ICUAW Trial)
What You Need to Know Before You Apply
What is the purpose of 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
Who Is on the Research Team?
Oussama Hassan, M.D.
Principal Investigator
Health Discovery Labs
Are You a Good Fit for This Trial?
This trial is for ICU patients at risk of muscle weakness due to critical illness, sepsis, or sarcopenia. Participants must be in the medical ICU and could benefit from interventions to prevent muscle loss. Specific criteria for joining or reasons for exclusion aren't provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard of care or standard of care plus daily 60-minute sessions of electrical muscle stimulation during ICU stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a survey three months after ICU discharge
What Are the Treatments Tested in This Trial?
Interventions
- MyokinE100 System
Trial Overview
The study tests a new device that uses electrical signals to stimulate thigh muscles in ICU patients. It aims to determine if this treatment is safe, practical, and can help reduce muscle weakening compared to standard care alone.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants will receive a daily 60-minute session of electrical muscle stimulation applied to the quadriceps for up to 7 days during ICU stay or until ICU discharge, alongside standard of care.
Participants will receive standard of care only
Find a Clinic Near You
Who Is Running the Clinical Trial?
Health Discovery Labs
Lead Sponsor
Mayo Clinic
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Ascension Health
Industry Sponsor
University of Texas at Austin
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.