xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06023511</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004235</org_study_id>
      <nct_id>NCT06023511</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers</brief_title>
    <official_title>Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Health Discovery Labs</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ascension Health</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Health Discovery Labs</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Every patient admitted to the Intensive Care Unit (ICU) is at risk of developing &quot;Intensive&#xD;
        Care Unit Acquired Weakness&quot; (ICUAW). ICUAW is associated with increased rate of mortality,&#xD;
        prolonged duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and&#xD;
        reduced quality of life. Currently, there is no effective treatment for ICUAW.&#xD;
  &#xD;
        Health Discovery Labs is conducting a research study to evaluate the safety of using an&#xD;
        innovative experimental medical device in ICU settings that could mitigate ICUAW.&#xD;
  &#xD;
        This study is meant to demonstrate whether this new device interferes with standard ICU&#xD;
        monitors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Every patient admitted to the ICU is at risk of developing ICU Acquired Weakness (ICUAW).&#xD;
        ICUAW begins within the first couple hours of hospitalization with approximately 11% of&#xD;
        muscle strength is lost per day. Further, 2.4 million patients per year in the US develop an&#xD;
        advanced form of ICUAW which is associated with increased rate of mortality, prolonged&#xD;
        duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced&#xD;
        quality of life. To mitigate ICUAW, early mobility is the lone strategy readily available to&#xD;
        clinicians to thwart ICUAW. Early mobility programs require patient's cooperation and&#xD;
        numerous ICU staff safely implement the intervention. Thus, uncooperative patients are&#xD;
        excluded from mobility efforts. Clearly, interventions that can be implemented with most any&#xD;
        ICU patient are urgently needed. Electrical muscle stimulation (EMS) is uniquely capable of&#xD;
        addressing this need by contracting muscles using skin-surface electrodes and electrical&#xD;
        pulses. Clinical data assessing the feasibility, safety, and efficacy of such intervention is&#xD;
        promising. However, technical limitations such as lack of electric safety in commercially&#xD;
        available devices, and the need for a skilled operator to install, setup, and monitor the&#xD;
        treatment session render the application of electrical muscle stimulation as a tool for early&#xD;
        rehabilitation in the ICU complex and expensive. To solve this problem, Health Discovery Labs&#xD;
        is developing an easy-to-use closed loop electrical muscle stimulation system (CL-EMS) with&#xD;
        improved electric safety. The objective of this interventional, open label single group&#xD;
        feasibility study is to assess whether the MyokinE100 (CL-EMS alpha) device developed by&#xD;
        Health Discovery Labs will interfere with cardiac monitoring devices commonly used in ICU&#xD;
        settings while inducing muscle contraction or twitching.&#xD;
  &#xD;
        In Simulation Lab ICU setting, at the Ascension Texas Clinical Education Center (CEC),&#xD;
        healthy volunteers will be placed in supine position on an electrically powered ICU bed,&#xD;
        connected to the cardiac monitor system, and to an external defibrillator in monitor mode. A&#xD;
        pair of garments containing off-the-shelf (OTS) electrodes will be wrapped around the thigh&#xD;
        area (both right and left lower limb) and connected to the MyokinE100 (CL-EMS alpha) device&#xD;
        developed by Health Discovery Labs. Volunteers will receive electrical muscle stimulation of&#xD;
        contralateral muscle groups for a total of 25 minutes. Before and during the electrical&#xD;
        muscle stimulation process, data related to the ECG patterns will be collected from the ECG&#xD;
        monitoring system, and the external defibrillator. Data related to the applied electrical&#xD;
        pulse characteristics will be collected from the device. Muscle response to electrical&#xD;
        stimulation will be objectively graded by the research team based on a scale for rating the&#xD;
        quality of muscle contractions. Comfort level will be graded by the volunteer using the&#xD;
        Numeric Rating Scale (NRS).&#xD;
  &#xD;
        Success will be judged based on the following criteria: (1) the use of the MyokinE100 (CL-EMS&#xD;
        alpha) device does not induce ECG noise of more than 0.1mV in amplitude in at least 70% of&#xD;
        the healthy volunteers; (2) does not introduce signals suggestive of cardiac dysrhythmias&#xD;
        (VF/VT/AF/PVC/PAC) in at least 70% of the healthy volunteers; and (3) induces visible muscle&#xD;
        contraction at the level of the quadriceps muscle group in at least 70% of the healthy&#xD;
        volunteers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 22, 2023</start_date>
    <completion_date type="Anticipated">August 23, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 23, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Interference with cardiac monitoring devices: detection of ECG noise of more than 0.1mV in amplitude or ECG changes suggestive of cardiac dysrhythmias</measure>
      <time_frame>During the 25 minutes that the EMS is applied to each test subject.</time_frame>
      <description>During electrical muscle stimulation using the MyokinE100 (CL-EMS alpha) device at the level of the quadriceps muscle, volunteers will be connected to cardiac monitoring device. ECG will be monitored for the detection of electric interference or the detection of noise suggestive of dysrhythmias.&#xD;
  Success will be based on the following criteria: (1) intervention does not induce noise of more than 0.1mV in amplitude; and (2) does not introduce signal suggestive of cardiac dysrhythmias (VT/VF/AF/PVC/PAC)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Grading of muscle contraction to electrical stimulation using the Gosselink scale</measure>
      <time_frame>During the 25 minutes that the EMS is applied to each test subject.</time_frame>
      <description>Evaluate the type of muscle contraction generated by the device in healthy volunteers using the scale of muscle contractions published by Gosselink et al. [PMID 25108833]</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>ICU Acquired Weakness</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Volunteers will receive electrical muscle stimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Electrical muscle stimulation</intervention_name>
      <description>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).</description>
      <arm_group_label>Intervention group</arm_group_label>
      <other_name>MyokinE100 (CL-EMS alpha)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Age 18 to 65&#xD;
  &#xD;
            -  Healthy volunteers with no significant past medical history&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            -  History of heart disease&#xD;
  &#xD;
            -  Family history of sudden cardiac death&#xD;
  &#xD;
            -  History of neurological or neuromuscular diseases, or genetic muscular disorders&#xD;
  &#xD;
            -  History of deep vein thrombosis&#xD;
  &#xD;
            -  Presence of implantable devices&#xD;
  &#xD;
            -  Recent hospitalization within the last 3-months (surgical or medical)&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Allergy to latex&#xD;
  &#xD;
            -  Allergy to carbon-based electrodes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Oussama Hassan, MD</last_name>
      <role>Study Director</role>
      <affiliation>Health Discovery Labs LLC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Paul Harford, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dell Medical School at The University of Texas at Austin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Oussama Hassan, MD</last_name>
      <phone>5122039474</phone>
      <email>O.Hassan@HealthDiscoveryLabs.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ascension Texas Clinical Education Center (CEC)</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Neosha Nunn</last_name>
        <phone>512-324-7349</phone>
        <email>neosha.nunn@ascension.org</email>
      </contact>
      <investigator>
        <last_name>Paul Harford, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Oussama Hassan, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Colleen O'Neill, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Daniel Ahle, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/24758618/</url>
      <description>ICU-acquired weakness and recovery from critical illness</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/25108833/</url>
      <description>Feasibility of neuromuscular electrical stimulation in critically ill patients</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Muscle weakness</keyword>
    <keyword>Critical care myopathy</keyword>
    <keyword>Electrical muscle stimulation</keyword>
    <keyword>Electromagnetic interference</keyword>
    <keyword>ICU monitoring</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06023511
  org study id: STUDY00004235
  nct id: NCT06023511
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Interference with cardiac monitoring devices: detection of ECG noise of more than 0.1mV in amplitude or ECG changes suggestive of cardiac dysrhythmias
  time frame: During the 25 minutes that the EMS is applied to each test subject.
  description: During electrical muscle stimulation using the MyokinE100 (CL-EMS alpha) device at the level of the quadriceps muscle, volunteers will be connected to cardiac monitoring device. ECG will be monitored for the detection of electric interference or the detection of noise suggestive of dysrhythmias.
  Success will be based on the following criteria: (1) intervention does not induce noise of more than 0.1mV in amplitude; and (2) does not introduce signal suggestive of cardiac dysrhythmias (VT/VF/AF/PVC/PAC)
  measure: Grading of muscle contraction to electrical stimulation using the Gosselink scale
  time frame: During the 25 minutes that the EMS is applied to each test subject.
  description: Evaluate the type of muscle contraction generated by the device in healthy volunteers using the scale of muscle contractions published by Gosselink et al. [PMID 25108833]
  arm group label: Intervention group
  arm group type: Experimental
  description: Volunteers will receive electrical muscle stimulation.
  intervention type: Device
  intervention name: Electrical muscle stimulation
  description: 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).
  arm group label: Intervention group
  other name: MyokinE100 (CL-EMS alpha)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Oussama Hassan, MD
  role: Study Director
  affiliation: Health Discovery Labs LLC
  last name: Paul Harford, MD
  role: Principal Investigator
  affiliation: Dell Medical School at The University of Texas at Austin
  last name: Oussama Hassan, MD
  phone: 5122039474
  email: O.Hassan@HealthDiscoveryLabs.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  url: https://pubmed.ncbi.nlm.nih.gov/24758618/
  description: ICU-acquired weakness and recovery from critical illness
  url: https://pubmed.ncbi.nlm.nih.gov/25108833/
  description: Feasibility of neuromuscular electrical stimulation in critically ill patients
  responsible party type: Sponsor
  mesh term: Asthenia
  sharing ipd: No