Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation (STRENGTH-ICU)
Primary Purpose
Muscle Weakness
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcutaneous electrical stimulation
Magnetic stimulation
ultrasound measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Muscle Weakness focused on measuring Intensive care unit acquired muscle weakness, Transcutaneous electrical stimulation, magnetic stimulation
Eligibility Criteria
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
Sites / Locations
- Chu Saint-EtienneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Magnetic and Transcutaneous electrical stimulation of quadriceps
Outcomes
Primary Outcome Measures
Reproductibility
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Secondary Outcome Measures
Reproductibility
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Reproductibility
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Reproductibility
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Reproductibility
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Reproductibility
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Reproductibility
Reproductibility of the force measurement after one simple electrical muscle stimulation
Reproductibility
Reproductibility of the force measurement after one simple electrical muscle stimulation
Reproductibility
Reproductibility of the force measurement after one simple electrical muscle stimulation
Reproductibility
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Reproductibility
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Reproductibility
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Intensive care unit acquired muscle weakness (ICUAW)
Occurrence of ICUAW defined by a MRC score less than 48
Full Information
NCT ID
NCT03270163
First Posted
August 10, 2017
Last Updated
April 24, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire de Physiologie de l'Exercice
1. Study Identification
Unique Protocol Identification Number
NCT03270163
Brief Title
Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation
Acronym
STRENGTH-ICU
Official Title
Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation in Intensive Care Unit Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire de Physiologie de l'Exercice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Intensive care unit acquired muscle weakness, Transcutaneous electrical stimulation, magnetic stimulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Magnetic and Transcutaneous electrical stimulation of quadriceps
Intervention Type
Diagnostic Test
Intervention Name(s)
Transcutaneous electrical stimulation
Intervention Description
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
Intervention Name(s)
Magnetic stimulation
Intervention Description
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
Intervention Name(s)
ultrasound measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reproductibility
Description
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Time Frame
At day 2
Secondary Outcome Measure Information:
Title
Reproductibility
Description
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Time Frame
At day 4
Title
Reproductibility
Description
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)
Title
Reproductibility
Description
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Time Frame
At day 2
Title
Reproductibility
Description
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Time Frame
At day 4
Title
Reproductibility
Description
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)
Title
Reproductibility
Description
Reproductibility of the force measurement after one simple electrical muscle stimulation
Time Frame
At day 2
Title
Reproductibility
Description
Reproductibility of the force measurement after one simple electrical muscle stimulation
Time Frame
At day 4
Title
Reproductibility
Description
Reproductibility of the force measurement after one simple electrical muscle stimulation
Time Frame
when the patient wakes up (on average 15 days)
Title
Reproductibility
Description
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Time Frame
At day 2
Title
Reproductibility
Description
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Time Frame
At day 4
Title
Reproductibility
Description
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Time Frame
At day 6
Title
Intensive care unit acquired muscle weakness (ICUAW)
Description
Occurrence of ICUAW defined by a MRC score less than 48
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme MOREL, MD
Phone
0477828553
Ext
33
Email
jerome.morel@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Béatrice DEYGAS, CRA
Email
beatrice.deygas@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme MOREL, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme MOREL, MD
Email
jerome.morel@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Jérôme MOREL
First Name & Middle Initial & Last Name & Degree
Laetitia BURNOL
First Name & Middle Initial & Last Name & Degree
Jean Baptiste BOUCHET
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation
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