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TerminatedNCT03270163STRENGTH-ICUUpdated Nov 15, 2024

Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation

An interventional study of Transcutaneous electrical stimulation and Magnetic stimulation in Muscle Weakness, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic

Why this study was terminated
no more inclusions possible
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Muscle Weakness

Keywords

  • Intensive care unit acquired muscle weakness
  • Transcutaneous electrical stimulation
  • magnetic stimulation
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Experimental

    Magnetic and Transcutaneous electrical stimulation of quadriceps

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

Interventions

  • Diagnostic testTranscutaneous 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 testMagnetic 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 testultrasound 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.

05

What researchers measure

Primary outcomes

  1. Reproductibility

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

    Time frame: At day 2

Secondary outcomes

  1. Reproductibility

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

    Time frame: At day 4

  2. Reproductibility

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

    Time frame: when the patient wakes up (on average 15 days)

  3. Reproductibility

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

    Time frame: At day 2

  4. Reproductibility

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

    Time frame: At day 4

  5. Reproductibility

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

    Time frame: when the patient wakes up (on average 15 days)

  6. Reproductibility

    Reproductibility of the force measurement after one simple electrical muscle stimulation

    Time frame: At day 2

  7. Reproductibility

    Reproductibility of the force measurement after one simple electrical muscle stimulation

    Time frame: At day 4

  8. Reproductibility

    Reproductibility of the force measurement after one simple electrical muscle stimulation

    Time frame: when the patient wakes up (on average 15 days)

  9. Reproductibility

    Reproductibility of the force measurement after one simple magnetic muscle stimulation

    Time frame: At day 2

  10. Reproductibility

    Reproductibility of the force measurement after one simple magnetic muscle stimulation

    Time frame: At day 4

  11. Reproductibility

    Reproductibility of the force measurement after one simple magnetic muscle stimulation

    Time frame: At day 6

  12. Intensive care unit acquired muscle weakness (ICUAW)

    Occurrence of ICUAW defined by a MRC score less than 48

    Time frame: 1 month

06

Study locations

1 site
  • Chu Saint-Etienne
    Saint-etienne, 42055, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03270163
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire de Physiologie de l'Exercice
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Feb 10, 2021
Primary completion
Jul 23, 2024
Completion
Aug 20, 2024
Last update
Nov 15, 2024

Study contacts

Jérôme MOREL, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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