Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation (STRENGTH-ICU)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Muscle Weakness
• Intervention / Treatment: Diagnostic test: Transcutaneous electrical stimulation; Diagnostic test: Magnetic stimulation; Diagnostic test: ultrasound measurement

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme MOREL, MD; Phone Number: 33 0477828553; Email: jerome.morel@chu-st-etienne.fr

Study Locations

• France
  • Saint-etienne, France, 42055
    • Recruiting
    • CHU Saint-Etienne
    • Contact: Jérôme MOREL, MD; Email: jerome.morel@chu-st-etienne.fr
    • Principal Investigator: Jérôme MOREL
    • Sub-Investigator: Laetitia BURNOL
    • Sub-Investigator: Jean Baptiste BOUCHET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; Magnetic and Transcutaneous electrical stimulation of quadriceps

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.; Diagnostic test: 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.; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproductibility	Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.	At day 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Laboratoire de Physiologie de l'Exercice

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: magnetic stimulation; Intensive care unit acquired muscle weakness; Transcutaneous electrical stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: 1708055; 2017-A00919-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No