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

NCT07362862 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STUDY00006725R44EB033725
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

Electrical muscle stimulation; Electrical Impedance Myography; Bioimpedance; Rehabilitation; Sepsis; Critical illness; ICU-acquired weakness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.

  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.

  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.

  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.

  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.

  Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.

Other Outcomes (2)

• Change in Impedance (Z), Reactance (X), and Phase Angle (PA) of the quadriceps muscle during the hospital stay.

  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.

  From enrollment to day 14.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

Participants will receive standard of care only

Interventions

Electrical Muscle Stimulation System DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: collaborator
• Mayo Clinic: collaborator
• Ascension Health: collaborator
• Health Discovery Labs: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Dell Seton Medical Center at The University of Texas

Austin, Texas, 78701, United States

Location

Ascension Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Sepsis; Critical Illness; Sarcopenia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Oussama Hassan, M.D.

  Health Discovery Labs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oussama Hassan, M.D.

CONTACT

512-203-9474; O.Hassan@healthdiscoverylabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two groups of participants will each receive different interventions

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (3)