Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation

NCT ID: NCT03270163

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2024-08-20

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Muscle Weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

Magnetic and Transcutaneous electrical stimulation of quadriceps

Group Type EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type 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.

Magnetic stimulation

Intervention Type 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.

ultrasound measurement

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire de Physiologie de l'Exercice

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme MOREL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2017-A00919-44

Identifier Type: OTHER

Identifier Source: secondary_id

1708055

Identifier Type: -

Identifier Source: org_study_id

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