Electrical Muscle Stimulation for Acquired Weakness

(ICUAW Trial)

Not yet recruiting at 2 trial locations
OH
Overseen ByOussama Hassan, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Health Discovery Labs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

OH

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

I am mostly independent in daily activities.
I have been diagnosed with sepsis or severe sepsis.
I was admitted to the ER or ICU in the last 2 days.
See 1 more

Exclusion Criteria

I am receiving care focused on my comfort.
Anticipated transfer to an ICU not participating in this study
Myopathies (e.g. congenital)
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either standard of care or standard of care plus daily 60-minute sessions of electrical muscle stimulation during ICU stay

Up to 7 days or until ICU discharge
Daily sessions in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a survey three months after ICU discharge

3 months

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

Group I: Intervention GroupActive Control1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Health Discovery Labs

Lead Sponsor

Trials
1
Recruited
8+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

Ascension Health

Industry Sponsor

Trials
28
Recruited
543,000+

University of Texas at Austin

Collaborator

Trials
387
Recruited
86,100+

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 ...

Closed 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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/22421734/

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 ...