Muscle WeaknessSTRENGTH-ICUNCT03270163
Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation
A study testing Transcutaneous electrical stimulation, Magnetic stimulation and ultrasound measurement in people with Muscle Weakness, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Transcutaneous electrical stimulation, Magnetic stimulation and ultrasound measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2021to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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.
- Conditions
- Muscle Weakness
- Being tested
- Transcutaneous electrical stimulation, Magnetic stimulation, ultrasound measurement
- Keywords
- Intensive care unit acquired muscle weakness, Transcutaneous electrical stimulation, magnetic stimulation
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulationDiagnostic 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 stimulationDiagnostic 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 measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Magnetic and Transcutaneous electrical stimulation of quadriceps Receives: Diagnostic Test: Transcutaneous electrical stimulation; Diagnostic Test: Magnetic stimulation; Diagnostic Test: ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductibility
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Measured: At day 2
Secondary outcomes (12)
Reproductibility
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Measured: At day 4
Reproductibility
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
Measured: 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.
Measured: At day 2
Reproductibility
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Measured: At day 4
Reproductibility
Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
Measured: when the patient wakes up (on average 15 days)
Reproductibility
Reproductibility of the force measurement after one simple electrical muscle stimulation
Measured: At day 2
Reproductibility
Reproductibility of the force measurement after one simple electrical muscle stimulation
Measured: At day 4
Reproductibility
Reproductibility of the force measurement after one simple electrical muscle stimulation
Measured: when the patient wakes up (on average 15 days)
Reproductibility
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Measured: At day 2
Reproductibility
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Measured: At day 4
Reproductibility
Reproductibility of the force measurement after one simple magnetic muscle stimulation
Measured: At day 6
Intensive care unit acquired muscle weakness (ICUAW)
Occurrence of ICUAW defined by a MRC score less than 48
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start10 Feb 2021
- Primary completion23 Jul 2024
- Study completion20 Aug 2024
Why it stopped: no more inclusions possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Physiologie de l'Exercice
- Responsible party
- Sponsor
- Investigators
- Jérôme MOREL, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270163
- Sponsor's protocol ID
- 1708055
- Other IDs
- 2017-A00919-44
- Acronym
- STRENGTH-ICU
- Status last verified
- Nov 2024
- First submitted
- 10 Aug 2017
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT03270163
- Acronym / sponsor ID
- STRENGTH-ICU / 1708055
- Conditions
- Muscle Weakness
- Keywords
- Intensive care unit acquired muscle weakness, Transcutaneous electrical stimulation, magnetic stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more inclusions possible
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Laboratoire de Physiologie de l'Exercice
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Transcutaneous electrical stimulation, Diagnostic Test: Magnetic stimulation, Diagnostic Test: ultrasound measurementMagnetic and Transcutaneous electrical stimulation of quadriceps |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical stimulationThe 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 | Experimental |
| Magnetic stimulationThe 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 | Experimental |
| ultrasound measurementThe 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. | Diagnostic test | Experimental |
Primary outcome
Reproductibility
Time frame: At day 2
Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
12 secondary outcomes
Reproductibility
Time frame: At day 4
Reproductibility
Time frame: when the patient wakes up (on average 15 days)
Reproductibility
Time frame: At day 2
Reproductibility
Time frame: At day 4
Reproductibility
Time frame: when the patient wakes up (on average 15 days)
Reproductibility
Time frame: At day 2
Reproductibility
Time frame: At day 4
Reproductibility
Time frame: when the patient wakes up (on average 15 days)
Reproductibility
Time frame: At day 2
Reproductibility
Time frame: At day 4
Reproductibility
Time frame: At day 6
Intensive care unit acquired muscle weakness (ICUAW)
Time frame: 1 month
Results and safety
The study was stopped early (reason given: no more inclusions possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme MOREL, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical stimulation, Magnetic stimulation and ultrasound measurement in people with Muscle Weakness, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no more inclusions possible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductibility (time frame: At day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.