Electrical Muscle Stimulation for Acquired Weakness
(ICUAW Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the MyokinE100 System, a new device that sends electrical signals to thigh muscles, can help prevent muscle weakness in ICU patients. The trial will assess the device's safety and ease of use for critically ill individuals. Participants will receive either standard care alone or standard care with additional electrical muscle stimulation. Eligible participants must have been recently admitted to the ICU and be at risk for conditions like sepsis (a severe infection). As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance ICU care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this device is safe for ICU patients?
Research has shown that the MyokinE100 System, which uses electrical signals to stimulate muscles, is generally safe for patients. Most people do not experience serious side effects from this treatment. The MyokinE100 System aims to prevent muscle weakness in very ill patients, particularly those in the ICU, where muscle weakness is common.
Some patients have reported mild discomfort, such as tingling or muscle soreness, during the treatment. However, these effects are usually temporary and not serious. Additionally, electrical muscle stimulation is already used in other medical treatments, confirming its safety.
Overall, evidence suggests that the MyokinE100 System is a safe choice for maintaining muscle strength in ICU patients.12345Why are researchers excited about this trial?
Most treatments for acquired muscle weakness in the ICU focus on standard physical therapy and supportive care. But the MyokinE100 System works differently by using electrical muscle stimulation (EMS) to directly activate muscle fibers. This method can potentially strengthen muscles faster and more effectively while patients are still in the ICU. Researchers are excited because EMS offers a non-invasive way to enhance muscle recovery, possibly reducing recovery time and improving outcomes for patients.
What evidence suggests that this device is effective for reducing muscle weakness in ICU patients?
Research shows that electrical muscle stimulation can help reduce muscle weakness in very sick patients. In this trial, participants in the intervention group will receive electrical muscle stimulation using the MyokinE100 system. Studies have found that this system can slow muscle loss, especially in ICU patients. Early results suggest that patients tolerate the side effects, making it a promising option for those at risk of losing muscle strength. While more information is needed, directly stimulating muscles might help maintain strength during long ICU stays. This could potentially lead to better recovery and care for patients.12356
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
Citations
MyokinE100 System: Closed Loop Electrical Muscle ...
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients (ICUAW). ClinicalTrials.gov ID ...
MyokinE100 System for ICU Acquired Weakness Prevention
The trial is important as it could potentially improve patient care and recovery in the ICU by addressing the challenge of muscle weakness.
Electrical Muscle Stimulation for Acquired Weakness · Info ...
... MyokinE100 System will have tolerable side effects & efficacy for patients with Critical Illness, Acquired Weakness, Sepsis, Sepsis, Sarcopenia, Acquired ...
4.
ctv.veeva.com
ctv.veeva.com/study/myokine100-system-closed-loop-electrical-muscle-stimulation-to-mitigate-icu-acquired-weakness-in-meClosed Loop Electrical Muscle Stimulation to Mitigate ICU ...
MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients (ICUAW) ... Data ...
Neuromuscular electrical stimulation for intensive care unit ...
Conclusions: If NMES is beneficial, the results of the study will help advance research aimed at reducing the burden of muscular weakness and physical ...
Neuromuscular Electrical Stimulation for Intensive Care Unit ...
Intensive care unit–acquired weakness is a specific term describing diffuse, symmetrical, generalized muscle weakness that develops after the onset of critical ...
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