<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/NCT04484285</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201901518 -A</org_study_id>
    <nct_id>NCT04484285</nct_id>
  </id_info>
  <brief_title>Home Operations Utilizing Stimulation</brief_title>
  <official_title>Home Operations Utilizing Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will utilize a home-operated stimulator in 1) a healthy young adult population&#xD;
      and 2) a healthy older adult population to provide a proof of concept of home-use of&#xD;
      transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive&#xD;
      performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vagal nerve is a major component of the autonomic nervous system and mediates the&#xD;
      physiological responses of major organs during moments of stress and learning, including&#xD;
      brain areas that modulate cognitive performance. Vagal nerve stimulation (VNS) has been&#xD;
      indicated to improve stress response and to enhance neuroplasticity by directly impacting&#xD;
      brain structures critical for cognition. Historically, VNS methods required neurosurgery and&#xD;
      were reserved for medically intractable epilepsy or other severe conditions. Today, vagal&#xD;
      nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery&#xD;
      through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will&#xD;
      utilize a home-operated stimulator in healthy young adult and healthy older populations to&#xD;
      provide a proof of concept of practical home-use stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">September 6, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 6, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>Up through Day 7</time_frame>
    <description>This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cognitive Performance</condition>
  <arm_group>
    <arm_group_label>Younger Cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy individuals aged 18 - 55</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Older Cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy individuals aged 56 - 85</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous Vagal Nerve Stimulation (tVNS)</intervention_name>
    <description>vagal nerve stimulation</description>
    <arm_group_label>Older Cohort</arm_group_label>
    <arm_group_label>Younger Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants for one cohort will be adults between the ages of 18-55, consistent with&#xD;
             the typical college population&#xD;
&#xD;
          -  Participants for the other cohort will be adults between the ages of 56 - 85.&#xD;
             Participants must read and write English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major medical illnesses including diagnosed severe neurological illnesses (e.g.,&#xD;
             stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g.,&#xD;
             schizophrenia) will be excluded. Participants with any history of brain surgery,&#xD;
             tumor, intracranial metal implantation, pacemakers or other implanted devices will be&#xD;
             excluded.&#xD;
&#xD;
          -  Sleep medications and/or psychostimulants are exclusionary. Subjects in the older&#xD;
             cohort will NOT be excluded for taking blood pressure and cholesterol medication.&#xD;
             Participants who are pregnant will be excluded. If participants have a history of&#xD;
             adverse reaction to electrical nerve stimulation, they will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eric Porges, PhD</last_name>
    <phone>352-294-5838</phone>
    <email>eporges@ufl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida McKnight Brain Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32643</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Porges, PhD</last_name>
      <phone>352-294-5838</phone>
      <email>eporges@ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Eric Porges, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</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/NCT04484285
org study id: IRB201901518 -A
nct id: NCT04484285
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This project will utilize a home-operated stimulator in 1) a healthy young adult population
      and 2) a healthy older adult population to provide a proof of concept of home-use of
      transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive
      performance.
The vagal nerve is a major component of the autonomic nervous system and mediates the
      physiological responses of major organs during moments of stress and learning, including
      brain areas that modulate cognitive performance. Vagal nerve stimulation (VNS) has been
      indicated to improve stress response and to enhance neuroplasticity by directly impacting
      brain structures critical for cognition. Historically, VNS methods required neurosurgery and
      were reserved for medically intractable epilepsy or other severe conditions. Today, vagal
      nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery
      through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will
      utilize a home-operated stimulator in healthy young adult and healthy older populations to
      provide a proof of concept of practical home-use stimulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: System Usability Scale
time frame: Up through Day 7
description: This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree).
arm group label: Younger Cohort
arm group type: Active Comparator
description: Healthy individuals aged 18 - 55
arm group label: Older Cohort
arm group type: Active Comparator
description: Healthy individuals aged 56 - 85
intervention type: Device
intervention name: Transcutaneous Vagal Nerve Stimulation (tVNS)
description: vagal nerve stimulation
arm group label: Older Cohort
arm group label: Younger Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Porges, PhD
phone: 352-294-5838
email: eporges@ufl.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor