UnknownNot Applicable

Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill

Slovenia20 participantsStarted 2023-12-08

Plain-language summary

ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge. Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans. In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers. In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy. To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals. The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * consecutive critically ill patients, already after 2 to 3 days of treatment in the ICU, whose treatment is expected to require at least 10 days in the intensive care unit. Exclusion Criteria: * Patients under 18 years of age * Patients with implanted electrical devices affected by magnetic fields * Patients with expected survival of less than 5 days * Pregnant women * Patients with bone and tissue injuries in the legs where standard physiotherapy cannot be performed * Patients receiving high-dose corticosteroids (equivalent to \>300 mg hydrocortisone per day) * Patients receiving muscle relaxants * Patients whose relatives/caregivers do not provide written consent for participation in the study * Patients with extreme obesity (BMI over 35 kg/m2) or cachexia (BMI less than 20 kg/m2 or loss of 5% Body weight over 12 months): * Patients with brain death * Patients who do not consent to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of Thickness of Thigh Muscles

Timeframe: 0 day, 3-5 days, 9-12 days

Trial details

NCT IDNCT06368908

SponsorGeneral and Teaching Hospital Celje

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-30

Contact for this trial

Matej Podbregar, MD PhD

+3864021560 matej.podbregar@guest.arnes.si

View on ClinicalTrials.gov More Critical Illness Myopathy trials