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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Health Discovery Labs
Study ID
NCT07362862
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Electrical Muscle Stimulation System — DEVICE
    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.

Study Details

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

Key Dates

Start date
May 5, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

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. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Division of Nursing Research
[email protected]
507-422-5523
Linda L. Chlan, Ph.D., RN, ATSF, FAAN
[email protected]
507-255-5728
Linda L. Chlan, Ph.D., RN, ATSF, FAAN (PRINCIPAL_INVESTIGATOR)
Erica D. Wittwer, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Ascension Seton Medical Center AustinAustinTexas78705
Paul H. Harford, M.D.
[email protected]
512-963-6362
Paul H. Harford, M.D. (PRINCIPAL_INVESTIGATOR)
Dell Seton Medical Center at The University of TexasAustinTexas78701
Paul H. Harford, M.D.
[email protected]
512-963-6362
Paul H. Harford, M.D. (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic· Rochester, MNAscension Seton Medical Center Austin· Austin, TXDell Seton Medical Center at The University of Texas· Austin, TX

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