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

Health Discovery Labs

Status: Not yet enrolling

Conditions: ICUAW; Secondary Sarcopenia; Critical Illness; ICU-acquired Weakness; Sarcopenia; ICU-acquired Muscle Weakness; Sepsis

Treatments: Device: Electrical Muscle Stimulation System

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07362862

STUDY00006725

R44EB033725 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

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.

Treatment:

Device: Electrical Muscle Stimulation System

Control Group

No Intervention group

Description:

Participants will receive standard of care only