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NCT06368908: FMS_ICU

Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill

Recruiting now NA Last updated 16 April 2024
What this trial tests

NA trial testing Transcutaneous Functional Magnetic Muscle Stimulation in Critical Illness Myopathy in 20 participants. Currently enrolling.

Timeline
8 December 2023
Primary endpoint
30 October 2024
30 December 2024

Quick facts

Lead sponsorGeneral and Teaching Hospital Celje
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment20
Start date8 December 2023
Primary completion30 October 2024
Estimated completion30 December 2024
Sites1 location across Slovenia

Drugs / interventions tested

Conditions studied

Sponsor

General and Teaching Hospital Celje

Who can join

Adults 18 to 100, any sex, with Critical Illness Myopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Functional Magnetic Neuromuscular Stimulation vs. Routine Physiotherapy in the Critically Ill for Prevention of ICU Acquired Muscle Loss: A Randomised Controlled Trial.
    Skočir A, Jevšnik A, Plaskan L, Podbregar M. · · 2024 · cited 3× · PMID 39459511 · DOI 10.3390/medicina60101724

Verify or expand the search:

Other recruiting trials for Critical Illness Myopathy

Currently open trials in the same condition.

Other General and Teaching Hospital Celje trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06368908.

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