Muscle Atrophy Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Texas
Ascension Seton Medical Center Austin
NOT_YET_RECRUITING
Austin
Dell Seton Medical Center at The University of Texas
NOT_YET_RECRUITING
Austin
Contact Information
Primary
Oussama Hassan, M.D.
O.Hassan@healthdiscoverylabs.com
512-203-9474
Time Frame
Start Date: 2026-05-05
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Treatments
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.
No_intervention: Control Group
Participants will receive standard of care only
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Ascension Health, National Institute for Biomedical Imaging and Bioengineering (NIBIB), University of Texas at Austin
Leads: Health Discovery Labs

This content was sourced from clinicaltrials.gov