<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/NCT02264262</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00036916</org_study_id>
    <nct_id>NCT02264262</nct_id>
  </id_info>
  <brief_title>Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers</brief_title>
  <official_title>Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Activation of the sympathetic nervous system is associated with increased risk of ventricular&#xD;
      arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable&#xD;
      tools to measure sympathetic outflow in human subjects is therefore highly desirable.&#xD;
&#xD;
      Microneurography is the current gold standard measurement technique, whereby multiunit&#xD;
      postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes&#xD;
      inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is&#xD;
      considered extremely safe, and has been used successfully for decades in human translational&#xD;
      physiology experiments, it has not been adopted for routine clinical assessment due to the&#xD;
      requirement for sophisticated equipment and specific technical training and skills.&#xD;
      Alternatively, many have adopted heart rate variability as a simple, noninvasive technique&#xD;
      for assessing sympathetic nerve activity. However, heart rate variability does not directly&#xD;
      measure sympathetic nerve activity, and there is much debate in the literature as to the&#xD;
      exact source of sympathetic nerve traffic. For example, many believe it is an accurate&#xD;
      reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in&#xD;
      muscle or skin sympathetic nerve activity.&#xD;
&#xD;
      To address these limitations, the investigators have developed a simple, noninvasive&#xD;
      technique to measure sympathetic nerve activity using surface electrodes.&#xD;
&#xD;
      Despite its great promise, this new approach has not yet been directly validated. The purpose&#xD;
      of this study is therefore to validate this new technique (refered to as EKG-NA) against the&#xD;
      current gold standard measurement technique, microneurography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chane in Sympathetic nerve activity</measure>
    <time_frame>Change from baseline in sympathetic nerve activity at 2 hours</time_frame>
    <description>Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve and EKG-NA by standard surface electrodes</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Sympathetic Nerve Activity</condition>
  <arm_group>
    <arm_group_label>Sympathetic nerve activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers will undergo microneurography, and non invasive sympathetic nerve activity by EKG analysis at baseline and in response to stress.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiologic maneuvers</intervention_name>
    <description>Subjects will perform cold pressor test, valsalva maneuver, hand grip and post-exercise occlusion in a controlled research environment</description>
    <arm_group_label>Sympathetic nerve activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-45 years of age&#xD;
&#xD;
          -  BMI &lt; 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypertension, diabetes, pulmonary disease, metabolic disease or heart&#xD;
             failure&#xD;
&#xD;
          -  Cardiac rhythm disorder, specifically: rhythm other than sinus&#xD;
&#xD;
          -  Use of any medications other than common supplements&#xD;
&#xD;
          -  Unable to perform handgrip exercise&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Victor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02264262
org study id: PRO00036916
nct id: NCT02264262
lead sponsor: 
has dmc: No
Activation of the sympathetic nervous system is associated with increased risk of ventricular
      arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable
      tools to measure sympathetic outflow in human subjects is therefore highly desirable.

      Microneurography is the current gold standard measurement technique, whereby multiunit
      postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes
      inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is
      considered extremely safe, and has been used successfully for decades in human translational
      physiology experiments, it has not been adopted for routine clinical assessment due to the
      requirement for sophisticated equipment and specific technical training and skills.
      Alternatively, many have adopted heart rate variability as a simple, noninvasive technique
      for assessing sympathetic nerve activity. However, heart rate variability does not directly
      measure sympathetic nerve activity, and there is much debate in the literature as to the
      exact source of sympathetic nerve traffic. For example, many believe it is an accurate
      reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in
      muscle or skin sympathetic nerve activity.

      To address these limitations, the investigators have developed a simple, noninvasive
      technique to measure sympathetic nerve activity using surface electrodes.

      Despite its great promise, this new approach has not yet been directly validated. The purpose
      of this study is therefore to validate this new technique (refered to as EKG-NA) against the
      current gold standard measurement technique, microneurography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Chane in Sympathetic nerve activity
time frame: Change from baseline in sympathetic nerve activity at 2 hours
description: Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve and EKG-NA by standard surface electrodes
arm group label: Sympathetic nerve activity
arm group type: Experimental
description: Healthy volunteers will undergo microneurography, and non invasive sympathetic nerve activity by EKG analysis at baseline and in response to stress.
intervention type: Other
intervention name: Physiologic maneuvers
description: Subjects will perform cold pressor test, valsalva maneuver, hand grip and post-exercise occlusion in a controlled research environment
arm group label: Sympathetic nerve activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald Victor, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Sponsor