Clinical trial NCT06023511: Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers
Official title: Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICU Acquired Weakness
Keywords: Muscle weakness
Critical care myopathy
Electrical muscle stimulation
Electromagnetic interference
ICU monitoring
Lead sponsor: Health Discovery Labs
Sponsor class: INDUSTRY
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: University of Texas at Austin
name: Ascension Health
First posted: 2023-09-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Grading of muscle contraction to electrical stimulation using the scale for rating the quality of muscle contractions.
timeFrame: During the 25 minutes that the EMS is applied to each test subject.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ascension Texas Clinical Education Center (CEC)
state: Texas
Study officials:
affiliation: Health Discovery Labs LLC
name: Oussama Hassan, MD
role: STUDY_DIRECTOR
affiliation: Dell Medical School at The University of Texas at Austin
name: Paul Harford, MD
role: PRINCIPAL_INVESTIGATOR
References: