Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation (NCT03270163) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation
Stopped: no more inclusions possible
France47 participantsStarted 2021-02-10
Plain-language 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).
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reproductibility
Timeframe: At day 2
Trial details
NCT IDNCT03270163
SponsorCentre Hospitalier Universitaire de Saint Etienne