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NOT YET RECRUITING
NCT07362862
NA

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

Sponsor: Health Discovery Labs

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-01-01

Completion Date

2026-08-31

Last Updated

2026-01-23

Healthy Volunteers

No

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.

Locations (3)

Mayo Clinic

Rochester, Minnesota, United States

Dell Seton Medical Center at The University of Texas

Austin, Texas, United States

Ascension Seton Medical Center Austin

Austin, Texas, United States