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 range18 Years – 65 Years

SexALL

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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

What they're measuring

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.

Trial details

NCT IDNCT06023511

SponsorHealth Discovery Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-23

View on ClinicalTrials.gov More ICU Acquired Weakness trials