Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation

NCT03270163 | Terminated

• 2 other identifiers: 17080552017-A00919-44
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Muscle Weakness

Keywords

Intensive care unit acquired muscle weakness; Transcutaneous electrical stimulation; magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Reproductibility

  Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.

  At day 2

Secondary Outcomes (12)

• Reproductibility

  At day 4

• Reproductibility

  when the patient wakes up (on average 15 days)

• Reproductibility

  At day 2

• Reproductibility

  At day 4

• Reproductibility

  when the patient wakes up (on average 15 days)

Study Arms (1)

Experimental

EXPERIMENTAL

Magnetic and Transcutaneous electrical stimulation of quadriceps

Diagnostic Test: Transcutaneous electrical stimulation; Diagnostic Test: Magnetic stimulation; Diagnostic Test: ultrasound measurement

Interventions

Transcutaneous electrical stimulation DIAGNOSTIC_TEST

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.

Experimental

Magnetic stimulation DIAGNOSTIC_TEST

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.

Experimental

ultrasound measurement DIAGNOSTIC_TEST

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Laboratoire de Physiologie de l'Exercice: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jérôme MOREL, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: September 1, 2017
• Study Start: February 10, 2021
• Primary Completion: July 23, 2024
• Study Completion: August 20, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)