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

Official title

Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness

Overview

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

Interventions

• Device Electrical Muscle Stimulation System
  Participants will receive electrical muscle stimulation at the level of the quadriceps using the MyokinE100 device, a closed-loop electrical muscle stimulation system. The closed-loop system monitors muscle response to electrical stimulation in real time using a biofeedback sensor and automatically adjusts stimulation intensity to achieve safe and effective muscle contractions.

Primary outcome measures

• Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge. [Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.]
• Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge. [Time frame: From Day 1 (enrollment) through the end of the subject's study participation at 3-months.]

Secondary outcome measures (12)

• Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge. [Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.]
• Change in hand-grip muscle strength measured by handheld dynamometry from ICU admission to hospital discharge. [Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14, and on hospital discharge day.]
• Change in mobility status assessed by ICU Mobility Scale (IMS) from ICU admission to ICU discharge. [Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.]
• Change in functional exercise capacity assessed by Six-Minute Walk Test (6MWT) between ICU discharge to hospital discharge. [Time frame: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.]
• Change in functional exercise capacity assessed by 30-Second Sit-to-Stand Test (30 s STS) between ICU discharge to hospital discharge. [Time frame: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.]
• Change in Rectus Femoris muscle structure assessed by musculoskeletal ultrasound from ICU admission to hospital discharge. [Time frame: From ICU admission to day 14.]
• Change in frailty status assessed by Clinical Frailty Scale (CFS) from ICU admission to 3-month post hospital discharge. [Time frame: Enrollment to 3-month follow-up.]
• Change in functional independence assessed by Barthel Index from ICU discharge to hospital discharge. [Time frame: Enrollment to 3-month follow-up.]
• Change in fatigue severity assessed by Visual Analog Scale for Fatigue (VAS-F) from ICU admission to hospital discharge. [Time frame: From ICU admission up to Day 14 or upon ICU discharge whichever comes first.]
• Change in health-related quality of life assessed by the RAND 36-Item Health Survey (SF-36) from the time of hospital discharge to 3-month follow-up after hospital discharge. [Time frame: Hospital discharge to 3-month follow-up after hospital discharge.]
• Change in employment status and work ability after hospital discharge. [Time frame: From ICU discharge to 3-month follow up after hospital discharge.]
• Duration of mechanical ventilation. [Time frame: From ICU admission to ICU discharge, an average of 7 days.]

Eligibility criteria

Inclusion criteria

• Admitted to ER or ICU within the previous 48 hours
• APACHE II score ≥ 13
• Meets the criteria for sepsis or severe sepsis

Exclusion criteria

• Anticipated transfer to an ICU not participating in this study
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 3 centers

• Mayo Clinic — Rochester
• Dell Seton Medical Center at The University of Texas — Austin
• Ascension Seton Medical Center Austin — Austin

Identifiers

NCT: NCT07362862 · STUDY00006725 · R44EB033725

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗