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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two groups of participants will each receive different interventions
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
No Intervention
Control Group 		Participants will receive standard of care only

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Division of Nursing Research
507-422-5523
RSTnursingresearch@mayo.edu

More Details

Status
Recruiting
Sponsor
Health Discovery Labs

Study Contact

Oussama Hassan, M.D.
512-203-9474
O.Hassan@healthdiscoverylabs.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.