Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers
Condition: ICU Acquired Weakness
MeSH terms: Asthenia
Study type: Interventional

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.
    

Detailed description: 
      Every patient admitted to the ICU is at risk of developing ICU Acquired Weakness (ICUAW).
      ICUAW begins within the first couple hours of hospitalization with approximately 11% of
      muscle strength is lost per day. Further, 2.4 million patients per year in the US develop an
      advanced form of ICUAW which is associated with increased rate of mortality, prolonged
      duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced
      quality of life. To mitigate ICUAW, early mobility is the lone strategy readily available to
      clinicians to thwart ICUAW. Early mobility programs require patient's cooperation and
      numerous ICU staff safely implement the intervention. Thus, uncooperative patients are
      excluded from mobility efforts. Clearly, interventions that can be implemented with most any
      ICU patient are urgently needed. Electrical muscle stimulation (EMS) is uniquely capable of
      addressing this need by contracting muscles using skin-surface electrodes and electrical
      pulses. Clinical data assessing the feasibility, safety, and efficacy of such intervention is
      promising. However, technical limitations such as lack of electric safety in commercially
      available devices, and the need for a skilled operator to install, setup, and monitor the
      treatment session render the application of electrical muscle stimulation as a tool for early
      rehabilitation in the ICU complex and expensive. To solve this problem, Health Discovery Labs
      is developing an easy-to-use closed loop electrical muscle stimulation system (CL-EMS) with
      improved electric safety. The objective of this interventional, open label single group
      feasibility study is to assess whether the MyokinE100 (CL-EMS alpha) device developed by
      Health Discovery Labs will interfere with cardiac monitoring devices commonly used in ICU
      settings while inducing muscle contraction or twitching.

      In Simulation Lab ICU setting, at the Ascension Texas Clinical Education Center (CEC),
      healthy volunteers will be placed in supine position on an electrically powered ICU bed,
      connected to the cardiac monitor system, and to an external defibrillator in monitor mode. A
      pair of garments containing off-the-shelf (OTS) electrodes will be wrapped around the thigh
      area (both right and left lower limb) and connected to the MyokinE100 (CL-EMS alpha) device
      developed by Health Discovery Labs. Volunteers will receive electrical muscle stimulation of
      contralateral muscle groups for a total of 25 minutes. Before and during the electrical
      muscle stimulation process, data related to the ECG patterns will be collected from the ECG
      monitoring system, and the external defibrillator. Data related to the applied electrical
      pulse characteristics will be collected from the device. Muscle response to electrical
      stimulation will be objectively graded by the research team based on a scale for rating the
      quality of muscle contractions. Comfort level will be graded by the volunteer using the
      Numeric Rating Scale (NRS).

      Success will be judged based on the following criteria: (1) the use of the MyokinE100 (CL-EMS
      alpha) device does not induce ECG noise of more than 0.1mV in amplitude in at least 70% of
      the healthy volunteers; (2) does not introduce signals suggestive of cardiac dysrhythmias
      (VF/VT/AF/PVC/PAC) in at least 70% of the healthy volunteers; and (3) induces visible muscle
      contraction at the level of the quadriceps muscle group in at least 70% of the healthy
      volunteers.
    

Intervention name(s): Electrical muscle stimulation
Intervention type(s): Device
Intervention description(s): While study subjects are connected to standard ICU monitors, electrical muscle stimulation will be applied at the level of the quadriceps muscle to induce palpable or visible muscle contraction. (No control group or sham procedure in this study).
Other intervention name(s): MyokinE100 (CL-EMS alpha)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Muscle weakness; Critical care myopathy; Electrical muscle stimulation; Electromagnetic interference; ICU monitoring