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

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

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

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.

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• National Institute for Biomedical Imaging and Bioengineering (NIBIB)

  collaborator NIH

• Ascension Health

  collaborator INDUSTRY

• University of Texas at Austin

  collaborator OTHER

• Health Discovery Labs

  lead INDUSTRY

Principal Investigators

• Oussama Hassan, M.D. · Health Discovery Labs

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-05

Primary Completion

2027-08-31

Completion

2027-08-31

FDA Device

Yes

Countries

• United States

Study Locations