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ICUAWMyokinE100 System for ICU Acquired Weakness Prevention

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Study Aim

This study aims to prevent ICU acquired weakness using the MyokinE100 system.

What is being tested

Electrical Muscle Stimulation System

Device
Who is being recruted

Atrophy+13

+ Infections

+ Inflammation

From 18 to 85 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorHealth Discovery Labs
Study ContactOussama Hassan, M.D.
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on testing the safety and usability of a new medical device, the MyokinE100 System, in the Intensive Care Unit (ICU). The device is designed to send electrical signals to the thigh muscles of ICU patients who are at risk of losing muscle strength. The study's main aim is to explore whether this treatment can help slow down muscle weakening, a common issue among critically ill patients. The trial is important as it could potentially improve patient care and recovery in the ICU by addressing the challenge of muscle weakness. During the study, participants will either receive standard care or standard care along with daily 60-minute sessions of electrical muscle stimulation using the MyokinE100 System. Researchers will compare these two groups to evaluate the safety and practicality of the device. Participants' muscle strength will be checked throughout the study. Additionally, they will complete a survey three months after leaving the ICU to assess their recovery progress. The study will investigate if participants experience any medical problems while receiving electrical muscle stimulation in the ICU.

Official TitleSafety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness 
NCT07362862
Principal SponsorHealth Discovery Labs
Study ContactOussama Hassan, M.D.
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AtrophyInfectionsInflammationMuscular AtrophyNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsCritical IllnessSystemic Inflammatory Response SyndromeSepsisPathological Conditions, AnatomicalNeuromuscular ManifestationsDisease AttributesSarcopenia

Criteria

4 inclusion criteria required to participate
APACHE II score ≥ 13

Meets the criteria for sepsis or severe sepsis

Admitted to ER or ICU within the previous 48 hours

Baseline Clinical Frailty Scale (CFS) ≤ 4

13 exclusion criteria prevent from participating
Expected length of ICU stay < 48 hours

Unable to transfer from bed to chair at baseline

Comfort care

Open wound or skin abrasion at the garment application site

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Mayo Clinic

Rochester, United StatesSee the location
Suspended

Dell Seton Medical Center at The University of Texas

Austin, United States
Suspended

Ascension Seton Medical Center Austin

Austin, United States
Recruiting soon3 Study Centers