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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Critical Illness; Sarcopenia; ICU-acquired Weakness; ICU-acquired Muscle Weakness; ICUAW; Secondary Sarcopenia
• Intervention / Treatment: Device: Electrical Muscle Stimulation System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oussama Hassan, M.D.; Phone Number: 512-203-9474; Email: O.Hassan@healthdiscoverylabs.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Division of Nursing Research; Phone Number: 507-422-5523; Email: RSTnursingresearch@mayo.edu
      • Contact: Linda L. Chlan, Ph.D., RN, ATSF, FAAN; Phone Number: 507-255-5728; Email: Chlan.Linda@mayo.edu
      • Principal Investigator: Linda L. Chlan, Ph.D., RN, ATSF, FAAN
      • Principal Investigator: Erica D. Wittwer, M.D., Ph.D.
  • Texas
    • Austin, Texas, United States, 78701
      • Not yet recruiting
      • Dell Seton Medical Center at The University of Texas
      • Contact: Paul H. Harford, M.D.; Phone Number: 512-963-6362; Email: PaulHarford@utexas.edu
      • Principal Investigator: Paul H. Harford, M.D.
    • Austin, Texas, United States, 78705
      • Not yet recruiting
      • Ascension Seton Medical Center Austin
      • Contact: Paul H. Harford, M.D.; Phone Number: 512-963-6362; Email: PaulHarford@utexas.edu
      • Principal Investigator: Paul H. Harford, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; 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.	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.
No Intervention: Control Group; Participants will receive standard of care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.	Lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Six muscle groups in lower limbs will be tested for a total best possible score of 30. A 1-point increase in MRC score per muscle group in the lower limbs is considered clinically significant.	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.	A single Unanticipated Adverse Device Effect (UADE) in any participant during the study is considered significant.	From Day 1 (enrollment) through the end of the subject's study participation at 3-months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.	Upper and lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score scale grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Twelve muscle groups will be tested for a total possible best score of 60. A 1-point change in MRC sum score is considered clinically significant.	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.	Handgrip muscle strength will be assessed using a handheld dynamometer (HHD) as an indicator of global muscle function. Participants will be considered to have ICU-Acquired Weakness (ICUAW) if the average handgrip strength is below the threshold of 11Kg for men or 7 Kg for woman. Higher scores in Kg indicate greater global muscle function.	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.	Functional mobility will be assessed using the ICU Mobility Scale (IMS), which ranges from 0 (lying in bed, no active movement) to 10 (walking independently without a gait aid). Higher scores indicate greater mobility.	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.	Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) which measures the distance a participant can walk on a flat surface in six minutes. A greater distance walked indicates better functional status.	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.	Functional exercise capacity will be assessed using the 30-Second Sit-to-Stand Test (30 s STS) which measures how many times a person can stand up from and sit down (one repetition) in an armless chair in 30 seconds. A higher number of repetitions indicates greater functional capacity.	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.	The Rectus Femoris muscle structure will be evaluated using musculoskeletal ultrasound. Measurements will include cross-sectional area, muscle circumference, pennation angle, and echo-intensity. Higher cross-sectional area, muscle circumference, and pennation angle indicate better muscle structure, while increased echo-intensity suggests worse muscle structure.	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.	Frailty will be assessed using the Clinical Frailty Scale (CFS), which ranges from 1 (very fit) to 7 (severely frail). Higher scores are worse.	Enrollment to 3-month follow-up.
Change in functional independence assessed by Barthel Index from ICU discharge to hospital discharge.	Functional independence will be assessed using the Barthel Index, which measures patient's ability in 10 activities of daily living (feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, chair transfers, mobility on level surfaces, and stairs). A higher score closer to 100 indicate greater functional independence.	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.	Fatigue will be assessed using the Visual Analog Scale for Fatigue (VAS-F), where participants rate their fatigue on a scale from 0 (no fatigue) to 10 (worst possible fatigue). Higher scores indicate greater fatigue.	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.	Health-related quality of life will be assessed using the RAND 36-Item Health Survey (SF-36), which evaluates eight domains including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health. Scores range from 0 to 100, with higher scores indicating better health status.	Hospital discharge to 3-month follow-up after hospital discharge.
Change in employment status and work ability after hospital discharge.	Employment status will be assessed during follow-up after hospital discharge using a structured questionnaire. Participants will report their current employment status and whether their ICU stay affected their ability to work. Return to work is considered best outcome.	From ICU discharge to 3-month follow up after hospital discharge.
Duration of mechanical ventilation.	The number of days from the initiation of mechanical ventilation to the discontinuation of mechanical ventilation. A lower number of days is better.	From ICU admission to ICU discharge, an average of 7 days.
Number of ventilator-free days within 28 days after ICU admission.	Ventilator-free days will be calculated as 28 minus total number of days on invasive mechanical ventilation during which the participant is alive and not receiving invasive mechanical ventilation. Participants who die within 28 days will be assigned zero ventilator-free days.	From extubation to day 28.
Number of days in ICU, hospital ward, and total hospital stay from admission to discharge.	Length of stay will be recorded in three categories: (1) ICU stay, defined as the total number of consecutive days from ICU admission to ICU discharge; (2) ward stay, defined as the number of days spent in a hospital ward after ICU discharge; and (3) total hospital stay, defined as the number of days from hospital admission to hospital discharge. The shorter the length of stay, the better.	From hospital admission to hospital discharge, an average of 14 days.
Discharge location after hospital stay.	Discharge location will be recorded at the time of hospital discharge using predefined categories: home, home with home health services, inpatient rehabilitation facility, skilled nursing facility, long-term acute care hospital, hospice, or death. Discharge home is considered the best outcome.	At the last day of hospitalization, average day 14.
Number of participants tolerating electrical muscle stimulation sessions during ICU stay.	Treatment session tolerance will be assessed using standardized scales. Tolerance is defined as: CPOT less than 7; NRS less than 8 at the thigh level; RASS less than +3 Scale ranges: CPOT (0 = relaxed, 8 = severe pain/agitation); NRS for pain (0 = no pain, 10 = worst pain),; RASS (-5 = unarousable, +4 = combative)	From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Number of participants with electrical interference on ECG monitoring during the stimulation sessions in the ICU.	Electrical interference with cardiac monitoring will be assessed during each electrical muscle stimulation (EMS) session using ECG tracings from standard ICU cardiac monitoring devices. Interference is defined as continuous 60-cycle (60 Hz) artifact for more than 60 seconds that impairs accurate interpretation of cardiac rhythm. ECG data will be captured only during EMS intervention sessions. Success is defined as 20% or less of ECG samples showing electrical interference as defined above.	From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.
Number of participants achieving significant muscle contraction during electrical muscle stimulation sessions as assessed by Muscle Contraction Scale during the ICU stay.	"Muscle contraction during electrical muscle stimulation (EMS) sessions will be assessed using the Muscle Contraction Scale, which classifies contraction from Type 1 (no palpable or visible contraction) to Type 5 (palpable and visible contraction with full muscle bulk). Participants achieved a response if they scored muscle contraction grade 3 or higher.	From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Impedance (Z), Reactance (X), and Phase Angle (PA) of the quadriceps muscle during the hospital stay.	Quadriceps muscle electrical properties will be measured using Electrical Impedance Myography (EIM). Measurements will include Impedance (Z in ohms), Reactance (X in ohms), and Phase Angle (PA in degrees), which reflect muscle composition. Lower Phase Angle and Reactance values indicate reduced muscle composition. Higher Impedance values generally indicate reduced muscle health.	From day 1 up to hospital discharge or day 14 whichever comes first.
Change in C-Terminal Agrin Fragment (CAF) level in blood and urine from enrollment to day 14.	C-Terminal Agrin Fragment (CAF) levels will be measured in blood and urine samples collected from enrollment through Day 14. Higher CAF levels may indicate increased neuromuscular junction degradation, while lower levels suggest better preservation of muscle function.	From enrollment to day 14.

Collaborators and Investigators

• Sponsor: Health Discovery Labs
• Collaborators: Mayo Clinic; National Institute for Biomedical Imaging and Bioengineering (NIBIB); University of Texas at Austin; Ascension Health
• Investigators: Principal Investigator: Oussama Hassan, M.D., Health Discovery Labs

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Critical illness; Sepsis; Bioimpedance; Electrical Impedance Myography; Electrical muscle stimulation; ICU-acquired weakness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Critical Illness; Sepsis; Sarcopenia
• Other Study ID Numbers: STUDY00006725; R44EB033725 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No