Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation

Muscle Weakness Clinical Trial

— STRENGTH-ICU  

Official title:

Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation in Intensive Care Unit Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270163
• Other study ID #: 1708055
• Secondary ID: 2017-A00919-44
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jérôme MOREL, MD
• Phone: 0477828553
• Email: jerome.morel[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acquired Neuromyopathy of Resuscitation (NMAR) is a common condition. Its diagnosis is difficult and often late because it is based on a clinical assessment of muscle strength (MRC score) requiring the patient to be awake and cooperative.

Transcutaneous electrical stimulation consists of applying electrical stimulation along the path of a motor nerve in order to generate contraction of the previously relaxed muscle. The mechanical response thus generated is recorded and allows the muscular strength developed to be assessed. Non-invasive and easily performed in the patient's bed, transcutaneous electrical stimulation could be an interesting alternative for early assessment of muscle strength in the still sedated resuscitation patient. However, this technique could be perceived as uncomfortable or painful in the awake patient so that magnetic stimulation, which is generally much better tolerated, should be preferred. However, magnetic stimulators have a limited maximum magnetic field which may prevent supramaximal stimulation especially in patients developing generalized edema (i.e., in the initial resuscitation phase).

Description:

We propose to conduct a reproducibility study of quadriceps force measurement in patients undergoing resuscitation by transcutaneous electrical and/or magnetic neurostimulation in the initial (i.e., < 96 h) and late (> 96 h) phases of resuscitation and then in the recovery phase. For each investigative technique (i.e., electrical vs. magnetic), we will perform 2 types of stimulation: single stimulation and high frequency doublet stimulation (100 Hz), repeated 3 times each.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• admitted in intensive care unit B of ST-Etienne hospital

• Predictable duration of mechanical ventilation of more than 72 hours

• Patient whose family has given informed and written consent to the patient's participation in the study

Exclusion Criteria:

• Pregnant woman,

• Patients with peripheral nerve damage prior to or at the time of measurement

• Curarized patients (non-efficacy of neurostimulation)

• Fracture of limb or pelvis

• Presence of a catheter in the stimulation zone (femoral artery or vein)

• Patients suffering from psychiatric pathologies.

• Brain pathology leading the patient to intensive care.

• Patients with neuromuscular pathology.

• Patients carrying equipment subject to possible electrical and/or magnetic interference,

• Patient with spinal fracture(s) at risk of spinal cord injury

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

Diagnostic Test:
• Transcutaneous electrical stimulation
The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening: three simple electrical stimulations, three electrical doublets at the frequency of 100Hz For each type of electrical stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.
• Magnetic stimulation
The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening: three simple magnetic stimulations, three magnetic doublets at the frequency of 100Hz For each type of magnetic stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.
• ultrasound measurement
The ultrasound measurement of the thickness of the quadriceps muscle will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Laboratoire de Physiologie de l'Exercice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproductibility	Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.	At day 2
Secondary	Reproductibility	Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.	At day 4
Secondary	Reproductibility	Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.	when the patient wakes up (on average 15 days)
Secondary	Reproductibility	Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.	At day 2
Secondary	Reproductibility	Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.	At day 4
Secondary	Reproductibility	Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.	when the patient wakes up (on average 15 days)
Secondary	Reproductibility	Reproductibility of the force measurement after one simple electrical muscle stimulation	At day 2
Secondary	Reproductibility	Reproductibility of the force measurement after one simple electrical muscle stimulation	At day 4
Secondary	Reproductibility	Reproductibility of the force measurement after one simple electrical muscle stimulation	when the patient wakes up (on average 15 days)
Secondary	Reproductibility	Reproductibility of the force measurement after one simple magnetic muscle stimulation	At day 2
Secondary	Reproductibility	Reproductibility of the force measurement after one simple magnetic muscle stimulation	At day 4
Secondary	Reproductibility	Reproductibility of the force measurement after one simple magnetic muscle stimulation	At day 6
Secondary	Intensive care unit acquired muscle weakness (ICUAW)	Occurrence of ICUAW defined by a MRC score less than 48	1 month