<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/NCT04455295</url>
  </required_header>
  <id_info>
    <org_study_id>Roosevelt_102218</org_study_id>
    <nct_id>NCT04455295</nct_id>
  </id_info>
  <brief_title>Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation</brief_title>
  <official_title>Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Tech University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Tech University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the&#xD;
      ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power.&#xD;
      Non-invasive alteration in locus coeruleus output is of interest in regard to basic science&#xD;
      and has potential clinical implications in a number of conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pupil Diameter</measure>
    <time_frame>Within single one hour session</time_frame>
    <description>Pupil diameter is measured via camera.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EEG Alpha power.</measure>
    <time_frame>Within single one hour session</time_frame>
    <description>Alpha power will be determined from EEG.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>no Condition</condition>
  <condition>Electroencephalography</condition>
  <condition>Pupil Diameter</condition>
  <arm_group>
    <arm_group_label>Active Stimulation 0.5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lobe Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonstimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placement of electrode without any stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transdermal Vagus Nerve Stimulation (tVNS)</intervention_name>
    <description>Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies.</description>
    <arm_group_label>Active Stimulation 0.5</arm_group_label>
    <arm_group_label>Lobe Control</arm_group_label>
    <arm_group_label>Nonstimulation</arm_group_label>
    <arm_group_label>Sham Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, 18 years of age or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self-report of mood disorders, prescription and non-prescription drug use which&#xD;
             includes stimulants including caffeine and nicotine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rodney W Roosevelt, Ph.D.</last_name>
    <phone>4793562006</phone>
    <email>rroosevelt@atu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Arkansas Tech University</name>
      <address>
        <city>Russellville</city>
        <state>Arkansas</state>
        <zip>72801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodney W Roosevelt, Ph.D.</last_name>
      <phone>479-356-2144</phone>
      <email>rroosevelt@atu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT04455295/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04455295
org study id: Roosevelt_102218
nct id: NCT04455295
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the
      ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power.
      Non-invasive alteration in locus coeruleus output is of interest in regard to basic science
      and has potential clinical implications in a number of conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Pupil Diameter
time frame: Within single one hour session
description: Pupil diameter is measured via camera.
measure: EEG Alpha power.
time frame: Within single one hour session
description: Alpha power will be determined from EEG.
arm group label: Active Stimulation 0.5
arm group type: Experimental
description: 0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.
arm group label: Lobe Control
arm group type: Placebo Comparator
description: 0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles.
arm group label: Sham Stimulation
arm group type: Placebo Comparator
description: 0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.
arm group label: Nonstimulation
arm group type: Placebo Comparator
description: Placement of electrode without any stimulation.
intervention type: Device
intervention name: Transdermal Vagus Nerve Stimulation (tVNS)
description: Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies.
arm group label: Active Stimulation 0.5
arm group label: Lobe Control
arm group label: Nonstimulation
arm group label: Sham Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rodney W Roosevelt, Ph.D.
phone: 4793562006
email: rroosevelt@atu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 