Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Slovenia
General Hospital Celje
RECRUITING
Celje
Contact Information
Primary
Matej Podbregar, MD PhD
matej.podbregar@guest.arnes.si
+3864021560
Backup
Anej Skočir, MD
anejskocir@gmail.com
+386 41 209802
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 20
Treatments
Experimental: Transcutaneous functional magnetic muscle stimulation
Transcutaneous Functional Magnetic Stimulation (FMS) Peripheral neuromuscular system stimulation will be conducted for the quadriceps femoris muscle using a magnetic stimulator (Tesla stym, Iskra Medical, Otoče, Slovenia). For magnetic stimulation, we will use pulse trains (20-50 Hz) with intensities ranging from 0.5 to 2.5 Tesla. The stimulation trains will be up to 3-6 seconds long, and the duty cycle will be varied from 1:1 to 1:10. Muscles will be stimulated with a magnetic field intensity that triggers visible contraction. The stimulation will last for 55 minutes per selected limb and will be performed 5 days a week.
No_intervention: Control
the quadriceps femoris muscle of the control leg will not be stimulated by Transcutaneous Functional Magnetic Stimulation
Sponsors
Leads: General and Teaching Hospital Celje

This content was sourced from clinicaltrials.gov