Recruiting

Electrical Muscle Stimulation

Sponsor:

Health Discovery Labs

Code:

NCT07362862

Conditions

Sepsis

Critical Illness

ICU-acquired Muscle Weakness

ICU-acquired Weakness

ICUAW

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electrical Muscle Stimulation System

Study Details

Brief 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

Study ID

NCT07362862

Start date

May 5, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted to ER or ICU within the previous 48 hours
  • APACHE II score ≥ 13
  • Meets the criteria for sepsis or severe sepsis

Exclusion Criteria:

  • Anticipated transfer to an ICU not participating in this study
  • 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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge. [ Time Frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first. ]
  • Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge. [ Time Frame: From Day 1 (enrollment) through the end of the subject's study participation at 3-months. ]

Central Contacts and Locations

Central contacts

Oussama Hassan, M.D.

512-203-9474O.Hassan@healthdiscoverylabs.com

Grace RH McDonough, MD Candidate, Class of 2030

G.McDonough@healthdiscoverylabs.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Division of Nursing Research

507-422-5523RSTnursingresearch@mayo.edu

Linda L. Chlan, Ph.D., RN, ATSF, FAAN

507-255-5728Chlan.Linda@mayo.edu

Principal Investigator:

Linda L. Chlan, Ph.D., RN, ATSF, FAAN

Dell Seton Medical Center at The University of Texas

Recruiting

Austin, Texas, United States, 78701

Contacts

Paul H. Harford, M.D.

512-963-6362PaulHarford@utexas.edu

Principal Investigator:

Paul H. Harford, M.D.

Ascension Seton Medical Center Austin

Recruiting

Austin, Texas, United States, 78705

Contacts

Paul H. Harford, M.D.

512-963-6362PaulHarford@utexas.edu

Principal Investigator:

Paul H. Harford, M.D.

More Information

Sponsor

Health Discovery Labs

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Electrical muscle stimulation
  • Electrical Impedance Myography
  • Bioimpedance
  • Rehabilitation
  • Sepsis
  • Critical illness
  • ICU-acquired weakness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Health Discovery Labs on 2026-07-10.