NCT07362862 MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
| NCT ID | NCT07362862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Health Discovery Labs |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-05-05 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Oussama Hassan, M.D.
PRINCIPAL INVESTIGATOR
Health Discovery Labs
Frequently Asked Questions
Who can join the NCT07362862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07362862 currently recruiting?
Yes, NCT07362862 is actively recruiting participants. Contact the research team at O.Hassan@healthdiscoverylabs.com for enrollment information.
Where is the NCT07362862 trial being conducted?
This trial is being conducted at Rochester, United States, Austin, United States, Austin, United States.
Who is sponsoring the NCT07362862 clinical trial?
NCT07362862 is sponsored by Health Discovery Labs. The principal investigator is Oussama Hassan, M.D. at Health Discovery Labs. The trial plans to enroll 50 participants.