Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill

NCT06368908 | Recruiting DMC

• 1 other identifier: 6I/2023/3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Critical illness; ICU acquired weakness; Functional magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Measurement of Thickness of Thigh Muscles

  Measurement of Thickness of Thigh Muscles by Ultrasound Thickness and cross-section of the muscle, muscle structure, assessment of subcutaneous edema will be evaluated using ultrasound examination with a linear probe 8-12MHz (UZ apparatus Vivid 70, GE Health care, USA). Ultrasound apparatus settings (frequency 12 Hz, Gain: 55 dB, Dynamic range: 75) will be kept constant for all patients, with depth adjusted only in the case of larger muscles. Measurements will be performed in transverse and sagittal muscle sections without and with compression of the ultrasound probe.

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

Secondary Outcomes (5)

• Measurement of Thigh Circumference

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

• Assessment of Muscle Strength and Communication Ability

  at admission and at the end of study (9-12day)

• Body composition measurement by bioimpedance- Extracellular water

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

• Body composition measurement by bioimpedance- Intracellular water

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

• Body composition measurement by bioimpedance- skeletal muscle mass

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

Study Arms (2)

Transcutaneous functional magnetic muscle stimulation

EXPERIMENTAL

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.

Device: Transcutaneous Functional Magnetic Muscle Stimulation

Control

NO INTERVENTION

the quadriceps femoris muscle of the control leg will not be stimulated by Transcutaneous Functional Magnetic Stimulation

Interventions

Transcutaneous Functional Magnetic Muscle Stimulation DEVICE

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.

Transcutaneous functional magnetic muscle stimulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• General and Teaching Hospital Celje: lead

Study Sites (1)

General Hospital Celje

Celje, 300, Slovenia

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman Parežnik, MD PhD

  General Hospital Celje

  STUDY CHAIR

Central Study Contacts

Matej Podbregar, MD PhD

CONTACT

+3864021560; matej.podbregar@guest.arnes.si

Anej Skočir, MD

CONTACT

+386 41 209802; anejskocir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One of legs is randomised to be stimulated by trans-cutaneous functional magnetic stimulation (Arm 1), the other leg is control (Arm 2)

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 16, 2024
• Study Start: December 8, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

SL (1)