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Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill

NCT06368908 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-16

No results posted yet for this study

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.

Conditions

  • Critical Illness Myopathy

Interventions

DEVICE

Transcutaneous Functional Magnetic Muscle Stimulation

Peripheral neuromuscular system stimulation will be conducted for the quadriceps femoris muscle using a magnetic stimulator (Tesla stym, Iskra Medical, Otoče, SLO). 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.

Sponsors & Collaborators

  • General and Teaching Hospital Celje

    lead OTHER

Principal Investigators

  • Roman Parežnik, MD PhD · General Hospital Celje

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2024-10-30
Completion
2024-12-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368908 on ClinicalTrials.gov