Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contractio… (NCT06023511) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers
United States8 participantsStarted 2023-08-22
Plain-language summary
Every patient admitted to the Intensive Care Unit (ICU) is at risk of developing "Intensive Care Unit Acquired Weakness" (ICUAW). ICUAW is associated with increased rate of mortality, prolonged duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced quality of life. Currently, there is no effective treatment for ICUAW.
Health Discovery Labs is conducting a research study to evaluate the safety of using an innovative experimental medical device in ICU settings that could mitigate ICUAW.
This study is meant to demonstrate whether this new device interferes with standard ICU monitors.
Who can participate
Age range
18 Years – 65 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:
* Male or female
* Age 18 to 65
* Healthy volunteers with no significant past medical history
Exclusion:
* History of heart disease
* Family history of sudden cardiac death
* History of neurological or neuromuscular diseases, or genetic muscular disorders
* History of deep vein thrombosis
* Presence of implantable devices
* Recent hospitalization within the last 3-months (surgical or medical)
* Pregnancy
* Allergy to latex
* Allergy to carbon-based electrodes
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
Interference with cardiac monitoring devices: detection of ECG noise of more than 0.1mV in amplitude or ECG changes suggestive of cardiac dysrhythmias
Timeframe: During the 25 minutes that the EMS is applied to each test subject.